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

Not Applicable

Not yet recruiting

• Conditions: Pain, Back

• Registration Number: NCT06430255
• Lead Sponsor: Taif University

Brief Summary

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

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 Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-16
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28
• Primary Completion: 2024-06-25
• Study Completion: 2024-06-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain intensity	One month	assessed using the Numerical Pain Rating Scale which goes from 0 ("no pain at all") to 10 ("worst imaginable pain")
Disability	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
Fingertip-to-floor test	7 weeks	excellent metric properties for LBP

Secondary Outcome Measures

Name	Time	Method
Pain catastrophizing	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
Kinesiophobia	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.
Depression	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.