The Effect of Neuroscience Pain Education on Quality of Life in Patients With Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain, Quality of Life, Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neuroscience pain education
Traditional patient education
Manual therapy
Sponsored by

About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Manual Therapy, Neuroscience pain education, Quality of life, 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
Exclusion Criteria:
- Previous spine or lower extremity surgery
- Severe osteoporosis
- Spondyloarthropathy
- Spondylolisthesis
- Lumbar stenosis
- Lumbar fractures
- Malign tumor
Sites / Locations
- Yoncali Physical Therapy and Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Patient received manual therapy in addition neuroscience pain education sessions
Patient received manual therapy in addition tradition education sessions
Outcomes
Primary Outcome Measures
Quality of Life (QOL): Turkish Short form-36 (SF-36) questionnaire
All patients additionally completed Turkish Short form-36 (SF-36) questionnaire, 36-item generic self-administered instrument that consists of eight subscales relating to various aspects of the QoL: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role and mental health. The eight subscales are scored from 0 to 100, with higher scores indicating better health status
Secondary 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.
Full Information
NCT ID
NCT03901365
First Posted
April 1, 2019
Last Updated
March 3, 2021
Sponsor
Kutahya Health Sciences University
1. Study Identification
Unique Protocol Identification Number
NCT03901365
Brief Title
The Effect of Neuroscience Pain Education on Quality of Life in Patients With Chronic Low Back Pain
Official Title
The Effect of Neuroplastic Pain Education on Quality of Life in Patients With Chronic Low Back Pain Who Treated Via Manual Therapy: a Single Blind Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (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
Manual therapy are among the therapeutic approaches frequently used in chronic low back pain (CLBP). Although most clinicians conduct patient education according biomedical model of pain, a relatively new approach which is referred to as neuroscience pain education (NPE) is promising in patients with CLBP. Therefore the aim of this study was to investigate whether NPE in patients with CLBP who treated via manual therapy technique will produce different outcomes in terms of pain severity and QoL compared to traditional patient education.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Quality of Life, Pain
Keywords
Manual Therapy, Neuroscience pain education, Quality of life, Chronic low back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Patient received manual therapy in addition neuroscience pain education sessions
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Patient received manual therapy in addition tradition education sessions
Intervention Type
Other
Intervention Name(s)
Neuroscience pain education
Intervention Description
In Neuroscience pain education (NPE) sessions, patients were informed about the pain experience and the neurophysiological process about pain. NPE was performed by the method proposed by Louw et al (12). NPE was administered 4 sessions per week for four weeks. Trainings were conducted in the form of face-to-face interview and 45-50 minutes of one-to-one sessions.
Intervention Type
Other
Intervention Name(s)
Traditional patient education
Intervention Description
In traditional patient education (TPE) sessions were aimed to explain to patients a proposed treatment or efficacy of a certain manual therapy technique or approach, have focused heavily on biomechanical and anatomical models. These models would imply that injury, disease, and muscle guarding may lead to altered movement patterns, asymmetrical loading, and resultant pain and dysfunction. TPE was administered 4 sessions per week for four weeks. Trainings were conducted in the form of face-to-face interview and 45-50 minutes of one-to-one sessions.
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life (QOL): Turkish Short form-36 (SF-36) questionnaire
Description
All patients additionally completed Turkish Short form-36 (SF-36) questionnaire, 36-item generic self-administered instrument that consists of eight subscales relating to various aspects of the QoL: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role and mental health. The eight subscales are scored from 0 to 100, with higher scores indicating better health status
Time Frame
Change from Baseline SF-36 at 4th weeks.
Secondary 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.
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
Exclusion Criteria:
Previous spine or lower extremity surgery
Severe osteoporosis
Spondyloarthropathy
Spondylolisthesis
Lumbar stenosis
Lumbar fractures
Malign tumor
Facility Information:
Facility Name
Yoncali Physical Therapy and Rehabilitation Hospital
City
Kutahya
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Neuroscience Pain Education on Quality of Life in Patients With Chronic Low Back Pain
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