Clinical trial NCT01060280: Effectiveness of Group GDS and Individual GDS for Treatment of Low Back Pain in Primary Care
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacute Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Keywords: low back pain
physiotherapy
exercise
active management
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 461
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Low back pain, referred pain and disability
timeFrame: Baseline, 2, 6 and 12 months
Secondary outcomes:
measure: Self-reported health (PCS and MCS summaries of SF-12), and use of other pharmacologic and non-pharmacologic treatments
timeFrame: Baseline, 2, 6 and 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Areas Nº 1 and 11. Primary Care. Spanish National Health Service in Madrid (SERMAS)
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, Spain
name: Francisco M Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kovacs Foundation, Palma de Mallorca, Spain
name: Mario Gestoso, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.