Chronic Nonspecific Low Back Pain, Subacute Nonspecific Low Back Pain
Conditions
Keywords
low back pain, physiotherapy, exercise, active management
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.
Interventions
BEHAVIORALEducation on active management
Routine clinical practice plus education on active management.
OTHERGroup GDS physiotherapy
Routine clinical practice (which will be substituted by Group GDS) plus education on active management.
OTHERIndividual GDS physiotherapy
Routine clinical practice (except for usual physiotherapy, which is substituted by Group and Individual GDS) plus education on active management.
Sponsors
Kovacs Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low back pain, referred pain and disability | Baseline, 2, 6 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Spain
Outcome results
None listed