- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03901365
The Effect of Neuroscience Pain Education on Quality of Life in Patients With Chronic Low Back Pain
March 3, 2021 updated by: Ismail Saracoglu, Kutahya Health Sciences University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kutahya, Turkey
- Yoncali Physical Therapy and Rehabilitation Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group 1
Patient received manual therapy in addition neuroscience pain education sessions
|
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.
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.
|
ACTIVE_COMPARATOR: Group 2
Patient received manual therapy in addition tradition education sessions
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life (QOL): Turkish Short form-36 (SF-36) questionnaire
Time Frame: Change from Baseline SF-36 at 4th weeks.
|
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
|
Change from Baseline SF-36 at 4th weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale (NPRS)
Time Frame: Change from Baseline NPRS at 4th weeks.
|
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.
|
Change from Baseline NPRS at 4th weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2018
Primary Completion (ACTUAL)
June 30, 2018
Study Completion (ACTUAL)
November 30, 2018
Study Registration Dates
First Submitted
April 1, 2019
First Submitted That Met QC Criteria
April 2, 2019
First Posted (ACTUAL)
April 3, 2019
Study Record Updates
Last Update Posted (ACTUAL)
March 5, 2021
Last Update Submitted That Met QC Criteria
March 3, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KutahyaMSUFTR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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