Back to resultsSpinal Cord Stimulation and Physiotherapy for Treatment of Neuropathic Pain (SCS-PHYSIO)
Primary Purpose
Neuropathic Pain
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Spinal Cord Stimulation (SCS)
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring Pain, Quality of Life, Electric Stimulation Therapy, Physiotherapy
Eligibility Criteria
Inclusion Criteria:
- Neuropathic pain > 6 months
- Pain intensity ≥ 5 according to NRS (for neuropathic pain component to be treated with SCS)
- Known cause of the pain
- Neuroanatomical correlation to the pain
- ≥50% of the painful area is to be treated with SCS
- The patient has a physical and psychological health status that allows the patient to participate in physiotherapy and undergo SCS implantation.
Exclusion Criteria:
- Not able to undergo SCS implantation
- Inadequate knowledge of the Swedish language
- Alcohol or substance abuse
- Severe untreated psychiatric disorders including psychiatric disease and/or psychological conditions which are the primary determinant to the patient's pain condition
- Incapacitating pain conditions of other causes than neuropathic pain
- Pregnancy
- Insufficient compliance
- Malignant disease with short expected survival
Sites / Locations
- Pain center, Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Spinal Cord Stimulation (SCS)
Physiotherapy
Arm Description
Spinal Cord Stimulation (SCS) Pharmacological analgetic treatment and treatment with SCS for 3 months Add-on physiotherapy for 6 months to SCS and pharmacological analgetic treatment Pharmacological analgetic treatment, SCS treatment and add-on self management physical activity for 12 months
Physiotherapy Pharmacological analgetic treatment for 3 months Physiotherapy for 3 months and pharmacological analgetic treatment Add-on SCS in combination with physiotherapy and pharmacological analgetic treatment for 3 months Pharmacological analgetic treatment, SCS treatment and add-on self management physical activity for 12 months
Outcomes
Primary Outcome Measures
Pain intensity according to numeric rating scale (NRS)
Number of patients who report ≥50% pain reduction (pain intensity) according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to neuropathic pain.
Secondary Outcome Measures
Pain intensity according to NRS
Number of patients who report ≥50% pain reduction (pain intensity) according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to neuropathic pain.
Pain intensity according to NRS
Number of patients who report ≥50% pain reduction (pain intensity) according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to neuropathic pain.
Pain intensity according to NRS
Number of patients who report ≥50% pain reduction (pain intensity) according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to neuropathic pain.
Pain intensity according to NRS
Number of patients who report ≥50% pain reduction (pain intensity) according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to neuropathic pain.
Pain intensity according to NRS
Number of patients who report ≥50% pain reduction (pain intensity) according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to neuropathic pain.
Health Related Quality of Life (HRQL) according to SF36
Assessed with RAND Short Form 36 (SF36). The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health. The subscale scores range from 0-100, the higher score, the better health related quality of life.
Health Related Quality of Life (HRQL) according to SF36
Assessed with RAND Short Form 36 (SF36). The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health. The subscale scores range from 0-100, the higher score, the better health related quality of life.
Health Related Quality of Life (HRQL) according to SF36
Assessed with RAND Short Form 36 (SF36). The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health. The subscale scores range from 0-100, the higher score, the better health related quality of life.
Health Related Quality of Life (HRQL) according to SF36
Assessed with RAND Short Form 36 (SF36). The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health. The subscale scores range from 0-100, the higher score, the better health related quality of life.
Health Related Quality of Life (HRQL) according to SF36
Assessed with RAND Short Form 36 (SF36). The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health. The subscale scores range from 0-100, the higher score, the better health related quality of life.
Health Related Quality of Life (HRQL) according to SF36
Assessed with RAND Short Form 36 (SF36). The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health. The subscale scores range from 0-100, the higher score, the better health related quality of life.
Health Related Quality of Life (HRQL) assessed with EQ-5D
Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Health Related Quality of Life (HRQL) assessed with EQ-5D
Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Health Related Quality of Life (HRQL) assessed with EQ-5D
Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Health Related Quality of Life (HRQL) assessed with EQ-5D
Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Health Related Quality of Life (HRQL) assessed with EQ-5D
Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Health Related Quality of Life (HRQL) assessed with EQ-5D
Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Physical activity
Assessed with accelerometer
Physical activity
Assessed with accelerometer
Physical activity
Assessed with accelerometer
Physical activity
Assessed with accelerometer
Physical activity
Assessed with accelerometer
Physical activity
Assessed with accelerometer
Return to work
Number of patients who return to work part time or full time.
Return to work
Number of patients who return to work part time or full time.
Days of sick-leave
Number of days of sick-leave
Days of sick-leave
Number of days of sick-leave
Medicine consumption
Number of pills and dosage.
Medicine consumption
Number of pills and dosage.
Number of hospital and primary care visits
Number of hospital and primary care visits
Number of hospital and primary care visits
Number of hospital and primary care visits
Patient treatment satisfaction according to NRS
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Patient treatment satisfaction according to NRS
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Patient treatment satisfaction according to NRS
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Patient treatment satisfaction according to NRS
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Patient treatment satisfaction according to NRS
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Patient treatment satisfaction according to NRS
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Full Information
NCT ID
NCT03740763
First Posted
May 9, 2018
Last Updated
November 9, 2018
Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region
1. Study Identification
Unique Protocol Identification Number
NCT03740763
Brief Title
Spinal Cord Stimulation and Physiotherapy for Treatment of Neuropathic Pain
Acronym
SCS-PHYSIO
Official Title
Treatment of Neuropathic Pain With Spinal Cord Stimulation and Physiotherapy for More Effective Pain Relief, Increased Physical Activity and Improved Health Related Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 9, 2018 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study evaluates the combined effect of optimized pharmacological treatment, spinal cord stimulation and physiotherapy on pain relief, health-related quality of life and physical function in patients with neuropathic pain. All patients will receive optimized pharmacological treatment before start of spinal cord stimulation treatment. Half of the participants will be randomized to physiotherapy before start of spinal cord stimulation treatment while the other half will start physiotherapy after spinal cord stimulation treatment.
Detailed Description
Previous studies have indicated that almost half of the patients with moderate-severe pain receive inadequate pain relief. Neuropathic pain is a common pain condition, affecting 1.5-8% of the population. Conventional pharmacological treatment reduces pain but is often insufficient. Spinal cord stimulation (SCS) is associated with improved pain relief and health-related quality of life compared to conventional medical management. Despite SCS treatment, only half of the patients report >50% pain relief. Other studies have indicated that active, specific physiotherapy led by professionals reduces pain in chronic pain conditions. The aim of the study is to access the combined effect of optimized pharmacological treatment, SCS and physiotherapy on pain relief, health-related quality of life and physical function in patients with neuropathic pain. Furthermore, the study evaluates when it is most effective to start the physiotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Pain, Quality of Life, Electric Stimulation Therapy, Physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Care Provider and Participants ar not masked. Data analysis of accelerometer data is masked (outcome assessor).
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spinal Cord Stimulation (SCS)
Arm Type
Active Comparator
Arm Description
Spinal Cord Stimulation (SCS)
Pharmacological analgetic treatment and treatment with SCS for 3 months
Add-on physiotherapy for 6 months to SCS and pharmacological analgetic treatment
Pharmacological analgetic treatment, SCS treatment and add-on self management physical activity for 12 months
Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
Physiotherapy
Pharmacological analgetic treatment for 3 months
Physiotherapy for 3 months and pharmacological analgetic treatment
Add-on SCS in combination with physiotherapy and pharmacological analgetic treatment for 3 months
Pharmacological analgetic treatment, SCS treatment and add-on self management physical activity for 12 months
Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulation (SCS)
Intervention Description
SCS for treatment of neuropathic pain
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Physiotherapy 2 hours/week with physiotherapist and physical activity counseling for treatment of neuropathic pain
Primary Outcome Measure Information:
Title
Pain intensity according to numeric rating scale (NRS)
Description
Number of patients who report ≥50% pain reduction (pain intensity) according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to neuropathic pain.
Time Frame
3 months after implantation
Secondary Outcome Measure Information:
Title
Pain intensity according to NRS
Description
Number of patients who report ≥50% pain reduction (pain intensity) according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to neuropathic pain.
Time Frame
9 months after implantation
Title
Pain intensity according to NRS
Description
Number of patients who report ≥50% pain reduction (pain intensity) according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to neuropathic pain.
Time Frame
6 months after implantation
Title
Pain intensity according to NRS
Description
Number of patients who report ≥50% pain reduction (pain intensity) according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to neuropathic pain.
Time Frame
12 months after implantation
Title
Pain intensity according to NRS
Description
Number of patients who report ≥50% pain reduction (pain intensity) according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to neuropathic pain.
Time Frame
15 months after implantation
Title
Pain intensity according to NRS
Description
Number of patients who report ≥50% pain reduction (pain intensity) according to numeric rating scale (score from 0 to 10, where 0 is described as "no pain" and 10 as "worst pain imaginable") with regard to neuropathic pain.
Time Frame
21 months after implantation
Title
Health Related Quality of Life (HRQL) according to SF36
Description
Assessed with RAND Short Form 36 (SF36). The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health. The subscale scores range from 0-100, the higher score, the better health related quality of life.
Time Frame
3 months after implantation
Title
Health Related Quality of Life (HRQL) according to SF36
Description
Assessed with RAND Short Form 36 (SF36). The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health. The subscale scores range from 0-100, the higher score, the better health related quality of life.
Time Frame
6 months after implantation
Title
Health Related Quality of Life (HRQL) according to SF36
Description
Assessed with RAND Short Form 36 (SF36). The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health. The subscale scores range from 0-100, the higher score, the better health related quality of life.
Time Frame
9 months after implantation
Title
Health Related Quality of Life (HRQL) according to SF36
Description
Assessed with RAND Short Form 36 (SF36). The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health. The subscale scores range from 0-100, the higher score, the better health related quality of life.
Time Frame
12 months after implantation
Title
Health Related Quality of Life (HRQL) according to SF36
Description
Assessed with RAND Short Form 36 (SF36). The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health. The subscale scores range from 0-100, the higher score, the better health related quality of life.
Time Frame
15 months after implantation
Title
Health Related Quality of Life (HRQL) according to SF36
Description
Assessed with RAND Short Form 36 (SF36). The 36 items in the questionnaire are grouped into eight subscale scores: physical functioning, role limitations caused by physical problems, bodily pain, general health, energy/vitality, social functioning, role limitations caused by emotional problems and mental health. The subscale scores range from 0-100, the higher score, the better health related quality of life.
Time Frame
21 months after implantation
Title
Health Related Quality of Life (HRQL) assessed with EQ-5D
Description
Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Time Frame
3 months after implantation
Title
Health Related Quality of Life (HRQL) assessed with EQ-5D
Description
Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Time Frame
6 months after implantation
Title
Health Related Quality of Life (HRQL) assessed with EQ-5D
Description
Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Time Frame
9 months after implantation
Title
Health Related Quality of Life (HRQL) assessed with EQ-5D
Description
Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Time Frame
12 months after implantation
Title
Health Related Quality of Life (HRQL) assessed with EQ-5D
Description
Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Time Frame
15 months after implantation
Title
Health Related Quality of Life (HRQL) assessed with EQ-5D
Description
Assessed with EQ-5D-5L. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Time Frame
21 months after implantation
Title
Physical activity
Description
Assessed with accelerometer
Time Frame
3 months
Title
Physical activity
Description
Assessed with accelerometer
Time Frame
6 months
Title
Physical activity
Description
Assessed with accelerometer
Time Frame
9 months
Title
Physical activity
Description
Assessed with accelerometer
Time Frame
12 months
Title
Physical activity
Description
Assessed with accelerometer
Time Frame
15 months
Title
Physical activity
Description
Assessed with accelerometer
Time Frame
21 months
Title
Return to work
Description
Number of patients who return to work part time or full time.
Time Frame
9 months
Title
Return to work
Description
Number of patients who return to work part time or full time.
Time Frame
21 months
Title
Days of sick-leave
Description
Number of days of sick-leave
Time Frame
9 months
Title
Days of sick-leave
Description
Number of days of sick-leave
Time Frame
21 months
Title
Medicine consumption
Description
Number of pills and dosage.
Time Frame
9 months
Title
Medicine consumption
Description
Number of pills and dosage.
Time Frame
21 months
Title
Number of hospital and primary care visits
Description
Number of hospital and primary care visits
Time Frame
9 months
Title
Number of hospital and primary care visits
Description
Number of hospital and primary care visits
Time Frame
21 months
Title
Patient treatment satisfaction according to NRS
Description
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Time Frame
3 months after implantation
Title
Patient treatment satisfaction according to NRS
Description
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Time Frame
6 months after implantation
Title
Patient treatment satisfaction according to NRS
Description
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Time Frame
9 months after implantation
Title
Patient treatment satisfaction according to NRS
Description
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Time Frame
12 months after implantation
Title
Patient treatment satisfaction according to NRS
Description
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Time Frame
15 months after implantation
Title
Patient treatment satisfaction according to NRS
Description
Self-reported treatment satisfaction with regard to pain relief, how acceptable the patient finds the treatment and hospital care. Numeric rating scale (score from 0 to 10, where 0 is described as "not satisfied at all" and 10 as "very satisfied") and numeric rating scale (score from 0 to 10, where 0 is described as "not acceptable at all" and 10 as "very acceptable").
Time Frame
21 months after implantation
Other Pre-specified Outcome Measures:
Title
Anxiety, depression
Description
Assessed with the Hospital Anxiety and Depression (HAD) scale. The scale consists of 14 items on a four-point response scale ranging from 0-3. Seven items for depression and 7 items for anxiety with a score range from 0-21. For each factor (anxiety or depression), the results are interpreted as follows: < 8 points indicates within normal range, 8-10 points indicates possible and >10 points indicates probable anxiety or depression.
Time Frame
3 months after implantation
Title
Anxiety, depression
Description
Assessed with the Hospital Anxiety and Depression (HAD) scale. The scale consists of 14 items on a four-point response scale ranging from 0-3. Seven items for depression and 7 items for anxiety with a score range from 0-21. For each factor (anxiety or depression), the results are interpreted as follows: < 8 points indicates within normal range, 8-10 points indicates possible and >10 points indicates probable anxiety or depression.
Time Frame
6 months after implantation
Title
Anxiety, depression
Description
Assessed with the Hospital Anxiety and Depression (HAD) scale. The scale consists of 14 items on a four-point response scale ranging from 0-3. Seven items for depression and 7 items for anxiety with a score range from 0-21. For each factor (anxiety or depression), the results are interpreted as follows: < 8 points indicates within normal range, 8-10 points indicates possible and >10 points indicates probable anxiety or depression.
Time Frame
9 months after implantation
Title
Anxiety, depression
Description
Assessed with the Hospital Anxiety and Depression (HAD) scale. The scale consists of 14 items on a four-point response scale ranging from 0-3. Seven items for depression and 7 items for anxiety with a score range from 0-21. For each factor (anxiety or depression), the results are interpreted as follows: < 8 points indicates within normal range, 8-10 points indicates possible and >10 points indicates probable anxiety or depression.
Time Frame
12 months after implantation
Title
Anxiety, depression
Description
Assessed with the Hospital Anxiety and Depression (HAD) scale. The scale consists of 14 items on a four-point response scale ranging from 0-3. Seven items for depression and 7 items for anxiety with a score range from 0-21. For each factor (anxiety or depression), the results are interpreted as follows: < 8 points indicates within normal range, 8-10 points indicates possible and >10 points indicates probable anxiety or depression.
Time Frame
15 months after implantation
Title
Anxiety, depression
Description
Assessed with the Hospital Anxiety and Depression (HAD) scale. The scale consists of 14 items on a four-point response scale ranging from 0-3. Seven items for depression and 7 items for anxiety with a score range from 0-21. For each factor (anxiety or depression), the results are interpreted as follows: < 8 points indicates within normal range, 8-10 points indicates possible and >10 points indicates probable anxiety or depression.
Time Frame
21 months after implantation
Title
Physical activity
Description
Assessed with the "Saltin-Grimby Physical Activity Level Scale" (SGPALS) is a scale that measures physical activity during the last year using the question "How much do you move and exert yourself physically during your leisure time?". The question has four options, where 1 is physically inactive and 4 is regular hard physical training for competitive sports.
Time Frame
3 months after implantations
Title
Physical activity
Description
Assessed with the "Saltin-Grimby Physical Activity Level Scale" (SGPALS) is a scale that measures physical activity during the last year using the question "How much do you move and exert yourself physically during your leisure time?". The question has four options, where 1 is physically inactive and 4 is regular hard physical training for competitive sports.
Time Frame
6 months after implantations
Title
Physical activity
Description
Assessed with the "Saltin-Grimby Physical Activity Level Scale" (SGPALS) is a scale that measures physical activity during the last year using the question "How much do you move and exert yourself physically during your leisure time?". The question has four options, where 1 is physically inactive and 4 is regular hard physical training for competitive sports.
Time Frame
9 months after implantations
Title
Physical activity
Description
Assessed with the "Saltin-Grimby Physical Activity Level Scale" (SGPALS) is a scale that measures physical activity during the last year using the question "How much do you move and exert yourself physically during your leisure time?". The question has four options, where 1 is physically inactive and 4 is regular hard physical training for competitive sports.
Time Frame
12 months after implantations
Title
Physical activity
Description
Assessed with the "Saltin-Grimby Physical Activity Level Scale" (SGPALS) is a scale that measures physical activity during the last year using the question "How much do you move and exert yourself physically during your leisure time?". The question has four options, where 1 is physically inactive and 4 is regular hard physical training for competitive sports.
Time Frame
15 months after implantations
Title
Physical activity
Description
Assessed with the "Saltin-Grimby Physical Activity Level Scale" (SGPALS) is a scale that measures physical activity during the last year using the question "How much do you move and exert yourself physically during your leisure time?". The question has four options, where 1 is physically inactive and 4 is regular hard physical training for competitive sports.
Time Frame
21 months after implantations
Title
Sleep quality according to Pittsburgh Sleep Quality Index
Description
Assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-rated questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep related problems. The 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component score are then summed to yield a global PSQI score which has a range of 0-21; higher scores indicate worse sleep quality.
Time Frame
3 months after implantation
Title
Sleep quality according to Pittsburgh Sleep Quality Index
Description
Assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-rated questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep related problems. The 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component score are then summed to yield a global PSQI score which has a range of 0-21; higher scores indicate worse sleep quality.
Time Frame
6 months after implantation
Title
Sleep quality according to Pittsburgh Sleep Quality Index
Description
Assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-rated questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep related problems. The 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component score are then summed to yield a global PSQI score which has a range of 0-21; higher scores indicate worse sleep quality.
Time Frame
9 months after implantation
Title
Sleep quality according to Pittsburgh Sleep Quality Index
Description
Assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-rated questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep related problems. The 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component score are then summed to yield a global PSQI score which has a range of 0-21; higher scores indicate worse sleep quality.
Time Frame
12 months after implantation
Title
Sleep quality according to Pittsburgh Sleep Quality Index
Description
Assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-rated questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep related problems. The 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component score are then summed to yield a global PSQI score which has a range of 0-21; higher scores indicate worse sleep quality.
Time Frame
15 months after implantation
Title
Sleep quality according to Pittsburgh Sleep Quality Index
Description
Assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 19 self-rated questions which assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and latency and of the frequency and severity of specific sleep related problems. The 19 items are grouped into seven component scores, each weighted equally on a 0-3 scale. The seven component score are then summed to yield a global PSQI score which has a range of 0-21; higher scores indicate worse sleep quality.
Time Frame
21 months after implantation
Title
Kinesiophobia
Description
Assessed with Tampa Scale of Kinesiophobia (TSK). The TSK is a 17 item scale, developed to measure pain related fear of movement. A total scores from 17 to 68 is calculated where the higher scores indicate an increasing degree of kinesiophobia.
Time Frame
3 months
Title
Kinesiophobia
Description
Assessed with Tampa Scale of Kinesiophobia (TSK). The TSK is a 17 item scale, developed to measure pain related fear of movement. A total scores from 17 to 68 is calculated where the higher scores indicate an increasing degree of kinesiophobia.
Time Frame
6 months
Title
Kinesiophobia
Description
Assessed with Tampa Scale of Kinesiophobia (TSK). The TSK is a 17 item scale, developed to measure pain related fear of movement. A total scores from 17 to 68 is calculated where the higher scores indicate an increasing degree of kinesiophobia.
Time Frame
9 months
Title
Kinesiophobia
Description
Assessed with Tampa Scale of Kinesiophobia (TSK). The TSK is a 17 item scale, developed to measure pain related fear of movement. A total scores from 17 to 68 is calculated where the higher scores indicate an increasing degree of kinesiophobia.
Time Frame
12 months
Title
Kinesiophobia
Description
Assessed with Tampa Scale of Kinesiophobia (TSK). The TSK is a 17 item scale, developed to measure pain related fear of movement. A total scores from 17 to 68 is calculated where the higher scores indicate an increasing degree of kinesiophobia.
Time Frame
15 months
Title
Kinesiophobia
Description
Assessed with Tampa Scale of Kinesiophobia (TSK). The TSK is a 17 item scale, developed to measure pain related fear of movement. A total scores from 17 to 68 is calculated where the higher scores indicate an increasing degree of kinesiophobia.
Time Frame
21 months
Title
Self-efficacy: A-SES-S
Description
Assessed with self-efficacy for arthritis (A-SES-S). A-SES is a self-efficacy questionnaire that contains 20 questions and measure a paitent's self-efficacy in three categories: capacity to handle pain, function and other symptoms. A total score between 10 and 100 is calculated, were a high total score indicates a high self-efficacy. The three categories can also be calculated separately and divided in number of questions also resulting of a score between 10 and 100. In the study we will analyze the categories "capacity to handle pain" and "other symptoms".
Time Frame
3 months
Title
Self-efficacy: A-SES-S
Description
Assessed with self-efficacy for arthritis (A-SES-S). A-SES is a self-efficacy questionnaire that contains 20 questions and measure a paitent's self-efficacy in three categories: capacity to handle pain, function and other symptoms. A total score between 10 and 100 is calculated, were a high total score indicates a high self-efficacy. The three categories can also be calculated separately and divided in number of questions also resulting of a score between 10 and 100. In the study we will analyze the categories "capacity to handle pain" and "other symptoms".
Time Frame
6 months
Title
Self-efficacy
Description
Assessed with self-efficacy for arthritis (A-SES-S). A-SES is a self-efficacy questionnaire that contains 20 questions and measure a paitent's self-efficacy in three categories: capacity to handle pain, function and other symptoms. A total score between 10 and 100 is calculated, were a high total score indicates a high self-efficacy. The three categories can also be calculated separately and divided in number of questions also resulting of a score between 10 and 100. In the study we will analyze the categories "capacity to handle pain" and "other symptoms".
Time Frame
9 months
Title
Self-efficacy: A-SES-S
Description
Assessed with self-efficacy for arthritis (A-SES-S). A-SES is a self-efficacy questionnaire that contains 20 questions and measure a paitent's self-efficacy in three categories: capacity to handle pain, function and other symptoms. A total score between 10 and 100 is calculated, were a high total score indicates a high self-efficacy. The three categories can also be calculated separately and divided in number of questions also resulting of a score between 10 and 100. In the study we will analyze the categories "capacity to handle pain" and "other symptoms".
Time Frame
12 months
Title
Self-efficacy: A-SES-S
Description
Assessed with self-efficacy for arthritis (A-SES-S). A-SES is a self-efficacy questionnaire that contains 20 questions and measure a paitent's self-efficacy in three categories: capacity to handle pain, function and other symptoms. A total score between 10 and 100 is calculated, were a high total score indicates a high self-efficacy. The three categories can also be calculated separately and divided in number of questions also resulting of a score between 10 and 100. In the study we will analyze the categories "capacity to handle pain" and "other symptoms".
Time Frame
15 months
Title
Self-efficacy: A-SES-S
Description
Assessed with self-efficacy for arthritis (A-SES-S). A-SES is a self-efficacy questionnaire that contains 20 questions and measure a paitent's self-efficacy in three categories: capacity to handle pain, function and other symptoms. A total score between 10 and 100 is calculated, were a high total score indicates a high self-efficacy. The three categories can also be calculated separately and divided in number of questions also resulting of a score between 10 and 100. In the study we will analyze the categories "capacity to handle pain" and "other symptoms".
Time Frame
21 months
Title
Self-efficacy for exercise
Description
Assessed with self-efficacy for exercise (SEE-SV). The self efficacy scale measures a patient's self-efficacy when it comes to physical exercise. The questionnaire consists of 9 questions that can be answered on a 1-10 scale. A total score between 9 and 90 is calculated, were a higher number represent a better outcome.
Time Frame
3 months
Title
Self-efficacy for exercise
Description
Assessed with self-efficacy for exercise (SEE-SV). The self efficacy scale measures a patient's self-efficacy when it comes to physical exercise. The questionnaire consists of 9 questions that can be answered on a 1-10 scale. A total score between 9 and 90 is calculated, were a higher number represent a better outcome.
Time Frame
6 months
Title
Self-efficacy for exercise
Description
Assessed with self-efficacy for exercise (SEE-SV). The self efficacy scale measures a patient's self-efficacy when it comes to physical exercise. The questionnaire consists of 9 questions that can be answered on a 1-10 scale. A total score between 9 and 90 is calculated, were a higher number represent a better outcome.
Time Frame
9 months
Title
Self-efficacy for exercise
Description
Assessed with self-efficacy for exercise (SEE-SV). The self efficacy scale measures a patient's self-efficacy when it comes to physical exercise. The questionnaire consists of 9 questions that can be answered on a 1-10 scale. A total score between 9 and 90 is calculated, were a higher number represent a better outcome.
Time Frame
12 months
Title
Self-efficacy for exercise
Description
Assessed with self-efficacy for exercise (SEE-SV). The self efficacy scale measures a patient's self-efficacy when it comes to physical exercise. The questionnaire consists of 9 questions that can be answered on a 1-10 scale. A total score between 9 and 90 is calculated, were a higher number represent a better outcome.
Time Frame
15 months
Title
Self-efficacy for exercise
Description
Assessed with self-efficacy for exercise (SEE-SV). The self efficacy scale measures a patient's self-efficacy when it comes to physical exercise. The questionnaire consists of 9 questions that can be answered on a 1-10 scale. A total score between 9 and 90 is calculated, were a higher number represent a better outcome.
Time Frame
21 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Neuropathic pain > 6 months
Pain intensity ≥ 5 according to NRS (for neuropathic pain component to be treated with SCS)
Known cause of the pain
Neuroanatomical correlation to the pain
≥50% of the painful area is to be treated with SCS
The patient has a physical and psychological health status that allows the patient to participate in physiotherapy and undergo SCS implantation.
Exclusion Criteria:
Not able to undergo SCS implantation
Inadequate knowledge of the Swedish language
Alcohol or substance abuse
Severe untreated psychiatric disorders including psychiatric disease and/or psychological conditions which are the primary determinant to the patient's pain condition
Incapacitating pain conditions of other causes than neuropathic pain
Pregnancy
Insufficient compliance
Malignant disease with short expected survival
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulin Andréll, MD, PhD
Organizational Affiliation
Göteborgs Universitet/Västra Götalandsregionen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain center, Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
416 50
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34854473
Citation
O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
Results Reference
derived
Links:
URL
https://www.researchweb.org/is/vgr/project/216271
Description
Project description in Swedish
Learn more about this trial
Spinal Cord Stimulation and Physiotherapy for Treatment of Neuropathic Pain
We'll reach out to this number within 24 hrs