Chronic Low Back Pain Clinical Trial
Official title:
Which Exercise for Low Back Pain? Predicting Response to Exercise Treatments for Patients With Low Back Pain: a Validation Pilot Study
Verified date | August 2019 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Dr. Macedo and others involved in the proposed research recently conducted a study that investigated whether simple clinical characteristics could identify patients who benefit more from either motor control exercises or graded activity. Results were statistically significant and clinically relevant demonstrating that a simple questionnaire could help aid the selection of the most appropriate exercise therapy for each individual patient. Therefore, we aim to conduct a randomized controlled trial following a similar approach to the original study to validate in a different sample the results of the effect modification analysis.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2018 |
Est. primary completion date | September 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients will be eligible for inclusion if they meet all of the following inclusion criteria: chronic non-specific LBP (>3 months) with or without leg pain, currently seeking care for LBP, between 18 to 80 years of age, English speaking (to allow response to the questionnaires and communication with the treating physiotherapist), Clinical assessment indicating that the participant is suitable for active exercises (by a family physician or using the Physical Activity Readiness Questionnaire), Moderate or greater pain or disability measured using question 7 or question 8 of the SF-36 Health Survey, moderate or High Risk Classification on the STarT Back Tool indicating appropriateness of physiotherapy and thus an exercise program. Exclusion Criteria: - Exclusion criteria will be known or suspected serious pathology, comorbidity that would prevent participation in exercise programs and scheduled for surgery during trial period. |
Country | Name | City | State |
---|---|---|---|
Canada | McMaster University | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Macquarie University, Australia, University of Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Effect Modifier - OREBRO | OREBRO LBP screening questionnaire is a 24 item scale to measure psychosocial risk factors for poor outcomes (scale from 11 to 192) | baseline | |
Other | Effect modifier _ Lumbar instability | Lumbar Spine Instability Questionnaire is a self reported scale to evaluate clinical instability on a scale from 0-15. | baseline | |
Other | Effect modifier _ Kinesiophobia | Pain Anxiety Symptom Scale (PASS - 20) is a scale used in chronic pain to evaluate kinesiophobia, anxiety and depression symptoms associated with pain experience. Scores are divided into cognitive (0 to 5), escape/avoidance (0 to 5), fear (0 to 5) and psychological anxiety (0 to 5). Total score from 0-100 | baseline | |
Other | Effect modifier_ Coping | Coping Strategies Questionnaire is a 6 item measure of coping in patients with chronic pain (00-36) | baseline | |
Primary | Patient Specific Functional Scale | This scale evaluates patient's self function on a scale from 0-10. | 12 months | |
Secondary | Patient Specific Functional Scale | This scale evaluates patient's self reported function on a scale from 0-10 | 2 and 6 month | |
Secondary | Roland Morris Disability Questionnaire | The RMDQ questionnaires evaluates pain related disability on a scale from 0-24. | 2, 6 and 12 months | |
Secondary | Numeric Rating Scale- pain | A numeric rating scale from 0-10 will be used to assess average level of pain over the last week | 2, 6 and 12 months | |
Secondary | SF-36 | The SF-36 will be used to assess self reported quality of life | 2, 6 and 12 months |
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