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

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

Study Contact Backup

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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