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| ID | Type | Description | Link |
|---|---|---|---|
| FK-DO 10/020 | Other Identifier | Hospital Doce de Octubre, Madrid, Spain |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education group | Active Comparator | Routine clinical practice (includes usual physiotherapy)plus education on active management. |
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| Group GDS physiotherapy | Active Comparator | Routine clinical practice (except usual physiotherapy, which is substituted for Group GDS)plus education on active management. |
|
| Individual GDS physiotherapy | Active Comparator | Routine clinical practice (except for usual physiotherapy, which will be substituted by Group and Individual GDS) plus education on active management. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education on active management | Behavioral | Routine clinical practice plus education on active management. |
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| Measure | Description | Time Frame |
|---|---|---|
| Low back pain, referred pain and disability | Baseline, 2, 6 and 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco M Kovacs, MD, PhD | Kovacs Foundation, Palma de Mallorca, Spain | Study Director |
| Mario Gestoso, MD | Kovacs Foundation, Palma de Mallorca, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Areas Nº 1 and 11. Primary Care. Spanish National Health Service in Madrid (SERMAS) | Madrid | Madrid | 28016 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15377573 | Background | Frost H, Lamb SE, Doll HA, Carver PT, Stewart-Brown S. Randomised controlled trial of physiotherapy compared with advice for low back pain. BMJ. 2004 Sep 25;329(7468):708. doi: 10.1136/bmj.38216.868808.7C. Epub 2004 Sep 17. | |
| 16721304 | Background | Rivero-Arias O, Gray A, Frost H, Lamb SE, Stewart-Brown S. Cost-utility analysis of physiotherapy treatment compared with physiotherapy advice in low back pain. Spine (Phila Pa 1976). 2006 May 20;31(12):1381-7. doi: 10.1097/01.brs.0000218486.13659.d5. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Group GDS physiotherapy | Other | Routine clinical practice (which will be substituted by Group GDS) plus education on active management. |
|
| Individual GDS physiotherapy | Other | Routine clinical practice (except for usual physiotherapy, which is substituted by Group and Individual GDS) plus education on active management. |
|
| 18713809 | Background | Little P, Lewith G, Webley F, Evans M, Beattie A, Middleton K, Barnett J, Ballard K, Oxford F, Smith P, Yardley L, Hollinghurst S, Sharp D. Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain. BMJ. 2008 Aug 19;337:a884. doi: 10.1136/bmj.a884. |
| 25359444 | Derived | Diaz-Arribas MJ, Kovacs FM, Royuela A, Fernandez-Serrano M, Gutierrez-Fernandez L, San Martin-Pariente O, Abraira V, Ramos-Sanchez M, Llorca-Palomera R, Pardo-Hervas P, Gestoso M, Sanchez-Gil GC, Elena-Lucas MA, Paniagua-de-la-Calle R, Castellanos-Lopez I, Garcia-Heredia MA, Ceron-Sanz AM, Victoria-Gonzalez B, Monsalve-Martin C, Duque-Heras JM, Juanes-Hernandez MJ, Saura-Conti J, Soto-Saez JL, Roman-Moraleda C, Ruiz-Arias C, Martin-Mora B, Escolano-Garcia R, Cantero-Bengoechea JS, Garcia-Lopez E, Lopez-Pelegrin A, Padilla-Martin E, Martinez-Rodriguez M, Casillas-Martin J, Jerez-Vazquez J, Barrientos-Gomez L; Spanish Back Pain Research Network. Effectiveness of the Godelieve Denys-Struyf (GDS) method in people with low back pain: cluster randomized controlled trial. Phys Ther. 2015 Mar;95(3):319-36. doi: 10.2522/ptj.20140099. Epub 2014 Oct 30. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |