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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06430255
Other study ID # 24-1243
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 16, 2024
Est. completion date June 25, 2024

Study information

Verified date May 2024
Source Taif University
Contact Alaa Baboor
Phone 966596628155
Email Alaa.s.baboor@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date June 25, 2024
Est. primary completion date June 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Global Postural Re-education
Program for treatment
Laser-guided Supervised Exercise
Program for treatment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taif University

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity assessed using the Numerical Pain Rating Scale which goes from 0 ("no pain at all") to 10 ("worst imaginable pain") One month
Primary 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
Primary Fingertip-to-floor test excellent metric properties for LBP 7 weeks
Secondary Pain catastrophizing 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
Secondary Kinesiophobia 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
Secondary Depression 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
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