The Effectiveness of the Physiotherapy Techniques Group GDS and Individual GDS for the Treatment of Nonspecific Low Back Pain in Primary Care. A Cluster, Randomized, Controlled Trial.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kovacs Foundation
- Enrollment
- 461
- Locations
- 1
- Primary Endpoint
- Low back pain, referred pain and disability
Overview
Brief Summary
A cluster, randomized, controlled clinical trial, where the hypothesis is that Group GDS and Individual GDS are effective in the treatment of nonspecific low back pain. The clusters will be the participating physiotherapy departments in primary care who treat patients with low back pain. In each physiotherapy department there will be 3 groups: education group, Group GDS and Individual GDS. Patients will be followed for 12 months. Variables will be: demographic,intensity of pain, disability, quality of life, patient satisfaction, medication intake for current episode, non-pharmacologic treatment for current episode, co-morbidity, diagnostic tests, sick leave, and habitual physical activity. The questionnaires to be used are: Roland Morris Disability Questionnaire, PI-NRS, VAS, SF-12 and EQ-5d.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosed with nonspecific low back pain by the primary care physician
- •more than or equal to 18 and less than or equal to 65 years of age
Exclusion Criteria
- •not signing the informed consent form
- •pregnancy
- •diagnosis of inflammatory rheumatologic disease, cancer, or fibromyalgia
- •signs for suspicion of fibromyalgia
- •having red flags for systemic disease
- •presenting criteria for urgent referral to surgery
- •presenting criteria for non-urgent referral to surgery
- •inability to read, understand, or follow verbal orders (dementia,blindness, doesn´t know how to read)
- •bedridden
- •having received physiotherapy in last 12 months
Outcomes
Primary Outcomes
Low back pain, referred pain and disability
Time Frame: Baseline, 2, 6 and 12 months
Secondary Outcomes
- Self-reported health (PCS and MCS summaries of SF-12), and use of other pharmacologic and non-pharmacologic treatments(Baseline, 2, 6 and 12 months)
Investigators
Francisco M. Kovacs
Director of Scientific Department, Kovacs Foundation
Kovacs Foundation