Preliminary development of a tool allowing to predict which patients with low back pain who would best benefit from a specific exercise program

Not Applicable

Completed

• Conditions: ow-back pain; Musculoskeletal Diseases; Low-back pain

• Registration Number: ISRCTN94152969
• Lead Sponsor: Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST)

Brief Summary

2017 Results article in https://pubmed.ncbi.nlm.nih.gov/29097271/ (added 01/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-08-01
• Study Start: 2016-11-14
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Patients with low-back pain:
1. Aged between 18 and 65
2. Fluency in either French or English
3. Experiencing LBP for at least four weeks, with or without leg pain
4. Scoring above 12% on the Oswestry disability questionnaire (OSW) [minimum clinically important change is 10 points]

Healthy controls:
1. Aged between 18 and 65
2. Fluency in either French or English

Exclusion Criteria

Patients with low-back pain:
1. Specific lumbar pathology (fracture, infection or tumor) or scoliosis
2. One positive neurological sign in two test categories (knee and ankle reflexes, myotomes, dermatomes)
3. Having previously undergone back surgery
4. Systemic disease
5. Having begun an exercise program in the last six months and (6) pregnancy.

Healthy controls:
1. Back pain in the preceding year or back pain exceeding one week in the years before
2. Surgery of the pelvis or spinal column
3. Systemic disease
4. Having begun an exercise program in the last three months
5. Pregnancy
6. Obesity (body mass index > 30 kg/m2)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Perceived disability is measured using the Oswestry disability questionnaire (OSW) at baseline, 4 weeks, 8 weeks and 6 months<br> 2. Pain intensity, measured using an 11-point (0 to 10) numeric pain rating scale (NPRS) to assess the current, best and worst levels of pain intensity during the last week, so as to average the three ratings and obtain a more reliable composite score at baseline, 4 weeks, 8 weeks and 6 months<br> 3. Patient satisfaction is measured using the Physical Therapy Patient Satisfaction (PTPS) questionnaire at 8 weeks<br>