NCT06430255

Brief Summary

Effects of Global Postural Re-education Versus Laser-guided Supervised Exercise in Individuals With Non-specific Chronic Low Back Pain

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

May 16, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

1 month

First QC Date

May 16, 2024

Last Update Submit

May 23, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain intensity

    assessed using the Numerical Pain Rating Scale which goes from 0 ("no pain at all") to 10 ("worst imaginable pain")

    One month

  • Disability

    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

    excellent metric properties for LBP

    7 weeks

Secondary Outcomes (3)

  • Pain catastrophizing

    One month

  • Kinesiophobia

    One month

  • Depression

    4 weeks

Study Arms (2)

Global Postural Re-education

EXPERIMENTAL

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.

Other: Global Postural Re-education

Laser-guided Supervised Exercise

EXPERIMENTAL

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,

Other: Laser-guided Supervised Exercise

Interventions

Program for treatment

Global Postural Re-education

Program for treatment

Laser-guided Supervised Exercise

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hosam Alzahrani, Dr

    Taif University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

May 16, 2024

First Posted

May 28, 2024

Study Start

May 16, 2024

Primary Completion

June 25, 2024

Study Completion

June 25, 2024

Last Updated

May 28, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share