- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06430255
Effects of Global Postural Re-education Versus Laser-guided Exercise in Non-specific Chronic Low Back Pain
May 23, 2024 updated by: Alaa Saleh Baboor, Taif University
Effects of Global Postural Re-education Versus Laser-guided Supervised Exercise in Individuals With Non-specific Chronic Low Back Pain: A Randomized Controlled Clinical Trial
Effects of Global Postural Re-education Versus Laser-guided Supervised Exercise in Individuals With Non-specific Chronic Low Back Pain
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The objective of this study will be to investigate the effectiveness of GPR or LGE, in addition to PNE and home exercise program.
The primary outcomes will be pain intensity, disability, and fingertip to floor test.
The secondary outcomes will be pain catastrophizing, kinesiophobia and depression.
Study Type
Interventional
Enrollment (Estimated)
36
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 Contact
- Name: Alaa Baboor
- Phone Number: 966596628155
- Email: Alaa.s.baboor@hotmail.com
Study Contact Backup
- Name: Ibrahim Alkayshan
- Phone Number: 966501272615
- Email: Ibrahim.alkayshan@gmail.com
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Aged between 18 and 45 years.
- Diagnosed with NSLBP.
- Experiencing NSCLBP for ≥ 3 months and score at least 3/10 on the Numerical Pain Rating Scale (NPRS).
Exclusion Criteria:
- Diagnosed with a condition that hinders their ability to engage in physical exercise (e.g., uncontrolled diabetes, cardiovascular disease, orthopedic impairments; balancing problems).
- Diagnosed with severe spine conditions (such as fractures, tumors, ankylosing spondylitis, or inflammatory disorders).
- Diagnosed with neurological problems (such as spine nerve problems or cauda equina syndrome)
- Diagnosed with mental illness or severe cognitive impairment that made it impossible to follow the PNE program.
- With a physical condition that made it impossible to complete the PNE program (the timed "up and go" test had to be completed in 10 seconds at a minimum).
- Receiving alternate therapy for related pathologies (myopathies and neurological diseases) that prevented them from completing the PNE program.
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Global Postural Re-education
is a physical therapy method developed in France by Philippe-Emmanuel Souchard.
This therapy method is founded on an integrated concept of the muscular system, which is composed of muscle chains.
These muscle chains are susceptible to shortening as a result of constitutional, behavioral, and psychological factors, Patients allocated to this group will be having a GPR method course of 8 sessions, two sessions per week for a four-week period.
Each session will consist of 3 therapeutic postures, lying, sitting, or standing, to be held for 15-20 minutes each.
The postures used are considered the most effective in lengthening the posterior chain, which is usually shortened in patients with LBP.
|
Program for treatment
|
|
Experimental: Laser-guided Supervised Exercise
Patients allocated to this group will be having a LGSE method course of 8 sessions, two sessions per week for a four-week period.
Each session will consist of lumbar movement control exercises.
The physiotherapist responsible for the intervention corrected each participant individually as required when performing the movement control exercises to ensure the correct technique.
The exercises is progress from the supine position through to standing, 4-point kneeling.
The program consists of 8 exercises first starting with abdominal-diaphragmatic breathing and isolated contraction of the transversus abdominis contractions of 10 seconds' duration 5 repetition, Abdominal preparation, Pelvic elevation with previous transversus abdominis contraction and neutral pelvis,
|
Program for treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: One month
|
assessed using the Numerical Pain Rating Scale which goes from 0 ("no pain at all") to 10 ("worst imaginable pain")
|
One month
|
|
Disability
Time Frame: 7 weeks
|
modified Oswestry Low Back Pain Disability (ODI) questionnaire Each part has six statements rated from 0 (least difficult to accomplish action) to 5 (most difficult) The overall score goes from 0 to 50 (the greatest impairment) In individuals with LBP
|
7 weeks
|
|
Fingertip-to-floor test
Time Frame: 7 weeks
|
excellent metric properties for LBP
|
7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain catastrophizing
Time Frame: One month
|
will be used to measure pain catastrophizing.
Scores range from 0 (never) to 4 (always) for each item (total score = 0-52).
Higher ratings reflect more catastrophizing of pain
|
One month
|
|
Kinesiophobia
Time Frame: One month
|
will be assessed using the 11 items that make up the TSK-11.
The overall score is between 11 and 44 points.
A higher score indicates a greater fear of discomfort, movement, and harm.
|
One month
|
|
Depression
Time Frame: 4 weeks
|
Patient Health Questionnaire (PHQ-9), The PHQ-9 is a self-administered 9-item questionnaire with four statements ranging from 0 (not at all) to 3 (nearly every day) for each item.
A higher total score (20-27) suggests that the patient is suffering from severe depression.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Hosam Alzahrani, Dr, Taif University
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 (Estimated)
May 16, 2024
Primary Completion (Estimated)
June 25, 2024
Study Completion (Estimated)
June 25, 2024
Study Registration Dates
First Submitted
May 16, 2024
First Submitted That Met QC Criteria
May 23, 2024
First Posted (Actual)
May 28, 2024
Study Record Updates
Last Update Posted (Actual)
May 28, 2024
Last Update Submitted That Met QC Criteria
May 23, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-1243
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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