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

Preliminary development of a clinical prediction rule for identifying patients with non-acute low back pain who respond best to a lumbar stabilization exercise program

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN94152969
Enrollment
90
Registered
2016-11-14
Start date
2012-10-17
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low-back pain Musculoskeletal Diseases Low-back pain

Interventions

All patients will take part in an 8-week lumbar stabilization exercise program, which consists of two 30 minute sessions per week, in local physiotherapy clinics without any co-intervention allowed. P

Sponsors

Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
1. Perceived disability is measured using the Oswestry disability questionnaire (OSW) at baseline, 4 weeks, 8 weeks and 6 months 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 3. Patient satisfaction is measured using the Physical Therapy Patient Satisfaction (PTPS) questionnaire at 8 weeks

Secondary

MeasureTime frame
Clinical assessment: Outcomes will be measured at baseline and 8 weeks 1. Posture (pelvic tilt, lordosis, kyphosis) and range of motion is measured using one or two inclinometers 2. Aberrant movements are measured using observations during flexion – extension 3. Lumbar instability is measured using the prone instability test 4. Ligamentous laxity is measured using the Beighton Scale 5. Lumbar instability is measured using painful arc in flexion 6. Lumbar instability is measured using painful arc in return from flexion 7. Posterior chain flexibility is measured using the passive straight leg rising test 8. Load transfer of lumbo-pelvic area is measured using the active straight leg rising test 9. Muscle testing is measured using three brief tests: side support, active set-up, extensor endurance 10. Physical performance is measured using repeated sit-to-stand, repeated trunk flexions, loaded reach and 360 degree rollover Psychological assessment: Outcomes will be measured at at baseline, 4 weeks, 8 weeks and 6 months, unless stated otherwise 1. Fear-avoidance beliefs are measured using the Fear-avoidance beliefs questionnaire (FABQ) 2. Pain catastrophizing is measured using the Pain Catastrophizing Scale (PCS) 3. Psychological distress is measured using the Psychological distress Inventory 4. Activity-related pain is measured by asking participant "Do you experience increased pain during general activity or exercise?" 5. The physical activity level is measured using the Baecke physical activity questionnaire (last month recall) 6. Self-efficacy for exercise is measured using the Self-efficacy for exercise Scale (SEES) 7. Barriers to exercise is measur

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026