Effectiveness of Group GDS and Individual GDS for Treatment of Low Back Pain in Primary Care

Study 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.

Official Title
-----------------
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.

Conditions
-----------------
Subacute Nonspecific Low Back Pain, Chronic Nonspecific Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: Education on active management
* Other: Group GDS physiotherapy
* Other: Individual GDS physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education group<br>Routine clinical practice (includes usual physiotherapy)plus education on active management. | Behavioral: Education on active management<br>* Routine clinical practice plus education on active management.<br>Other: Group GDS physiotherapy<br>* Routine clinical practice (which will be substituted by Group GDS) plus education on active management.<br>Other: Individual GDS physiotherapy<br>* Routine clinical practice (except for usual physiotherapy, which is substituted by Group and Individual GDS) plus education on active management.<br>|
| Active Comparator: Group GDS physiotherapy<br>Routine clinical practice (except usual physiotherapy, which is substituted for Group GDS)plus education on active management. | Other: Group GDS physiotherapy<br>* Routine clinical practice (which will be substituted by Group GDS) plus education on active management.<br>Other: Individual GDS physiotherapy<br>* Routine clinical practice (except for usual physiotherapy, which is substituted by Group and Individual GDS) plus education on active management.<br>|
| Active Comparator: Individual GDS physiotherapy<br>Routine clinical practice (except for usual physiotherapy, which will be substituted by Group and Individual GDS) plus education on active management. | Other: Individual GDS physiotherapy<br>* Routine clinical practice (except for usual physiotherapy, which is substituted by Group and Individual GDS) plus education on active management.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back pain, referred pain and disability |  | Baseline, 2, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, physiotherapy, exercise, active management