Back to resultsNeuroscience Pain Education in Patients With Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain, Manual Therapy, Neuroscience Pain Education
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
neuroscience pain education
manual therapy
home exercises
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Volunteered to participate in the study.
- Patients with 18-65 years
- Had low back pain for at least 6 months,
- Reported pain severity of 5 or greater according to the numeric pain rating scale
- Used pregabalin and gabapentin derivatives,
Exclusion Criteria:
- Previous spine or lower extremity surgery
- Severe osteoporosis
- Spondyloarthropathy
- Spondylolisthesis
- Lumbar stenosis
- Systemic inflammatory diseases
Sites / Locations
- Yoncali Physical Therapy and Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Neuroscience pain education group
Manual therapy group
Control group
Arm Description
in Group 1, participants received Neuroscience pain education, manual therapy and a home exercise program.
in Group 2, participants received manual therapy and a home exercise program.
in Group 3, participants received home exercise program only.
Outcomes
Primary Outcome Measures
Numeric pain rating scale (NPRS)
The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale from 0 to 10. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme.
Secondary Outcome Measures
Oswestry Disability Index (ODI)
The participants' level of functioning was evaluated using the Turkish adaptation of the ODI. The scale comprises 10 items, each with 6 options worth 0 to 5 points. For each item, participants are asked to mark the option that best describes their current condition. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Back Performance Scale (BPS)
The BPS includes five tests of trunk mobility. Each test is scored from 0 to 3 based on the observed level of physical performance, and total score ranges from 0 to 15 points (18). High score indicates poor performance.
Tampa Scale for Kinesiophobia (TSK)
TSK was used for the assessment of kinesiophobia. The items are rated on a 4-point Likert-type scale (1=definitely disagree, 4=completely agree) and the total score is between 17 and 68 points. Higher total score indicates higher level of kinesiophobia.
Full Information
NCT ID
NCT03886636
First Posted
March 19, 2019
Last Updated
March 21, 2019
Sponsor
Kutahya Health Sciences University
1. Study Identification
Unique Protocol Identification Number
NCT03886636
Brief Title
Neuroscience Pain Education in Patients With Chronic Low Back Pain
Official Title
The Effectiveness of Neuroscience Pain Education Combining Manual Therapy in Patients With Chronic Low Back Pain: a Single-blinded Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The cognitive educational strategies such as neuroscience pain education, has been a popular and promising technique for treatment patients with chronic pain. However, there are not sufficient randomized controlled and blinded studies to explore clinical effectiveness of these techniques. Therefore, the aim of this study was determining the short- and mid-term effects of neuroscience pain education combined with manual therapy and home exercise on pain level, disability, and kinesiophobia in patients with chronic low back pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Manual Therapy, Neuroscience Pain Education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neuroscience pain education group
Arm Type
Experimental
Arm Description
in Group 1, participants received Neuroscience pain education, manual therapy and a home exercise program.
Arm Title
Manual therapy group
Arm Type
Experimental
Arm Description
in Group 2, participants received manual therapy and a home exercise program.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
in Group 3, participants received home exercise program only.
Intervention Type
Other
Intervention Name(s)
neuroscience pain education
Intervention Description
A total of 4 NPE (Neuroscience paine education) sessions were held, once each week, before an MT session. The NPE sessions were conducted by an experienced physiotherapist certified in NPE in face-to-face, one-on-one sessions lasting 40-45 minutes. In NPE, the patient is taught about the physiology of pain, central sensitization, representation of the different body regions in the brain, pain-related changes in body perception, and the psychosocial dimensions of pain.
Intervention Type
Other
Intervention Name(s)
manual therapy
Intervention Description
In our study, Manual therapy (MT) was individualized according to each patient's response to treatment. In this method, the physiotherapist identifies and performs techniques suitable for the patient's symptoms. If the selected techniques do not have a direct positive effect on the patient's symptoms, they are replaced with other techniques.MT were performed in a total of 8 sessions, held twice a week for 4 weeks. Treatment sessions lasted an average of 40-45 minute.The entire treatment program was carried out by the same physiotherapist who is trained and experienced in this area.
Intervention Type
Other
Intervention Name(s)
home exercises
Intervention Description
All participants in all groups were assigned the home exercise program. The program aims to increase strength and flexibility of the abdominal, erector spinae, gluteal, quadriceps, and hamstring muscles. The participants were then asked to perform all of the exercises with 10 repetitions of each exercise 3 times a day for 4 weeks.
Primary Outcome Measure Information:
Title
Numeric pain rating scale (NPRS)
Description
The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale from 0 to 10. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme.
Time Frame
Change from Baseline NPRS at 4th weeks and 12th weeks
Secondary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Description
The participants' level of functioning was evaluated using the Turkish adaptation of the ODI. The scale comprises 10 items, each with 6 options worth 0 to 5 points. For each item, participants are asked to mark the option that best describes their current condition. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Time Frame
Change from Baseline ODI at 4th weeks and 12th weeks
Title
Back Performance Scale (BPS)
Description
The BPS includes five tests of trunk mobility. Each test is scored from 0 to 3 based on the observed level of physical performance, and total score ranges from 0 to 15 points (18). High score indicates poor performance.
Time Frame
Change from Baseline BPS at 4th weeks and 12th weeks
Title
Tampa Scale for Kinesiophobia (TSK)
Description
TSK was used for the assessment of kinesiophobia. The items are rated on a 4-point Likert-type scale (1=definitely disagree, 4=completely agree) and the total score is between 17 and 68 points. Higher total score indicates higher level of kinesiophobia.
Time Frame
Change from Baseline TSK at 4th weeks and 12th weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Volunteered to participate in the study.
Patients with 18-65 years
Had low back pain for at least 6 months,
Reported pain severity of 5 or greater according to the numeric pain rating scale
Used pregabalin and gabapentin derivatives,
Exclusion Criteria:
Previous spine or lower extremity surgery
Severe osteoporosis
Spondyloarthropathy
Spondylolisthesis
Lumbar stenosis
Systemic inflammatory diseases
Facility Information:
Facility Name
Yoncali Physical Therapy and Rehabilitation Hospital
City
Kutahya
ZIP/Postal Code
43000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neuroscience Pain Education in Patients With Chronic Low Back Pain
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