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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01060280
Other study ID # FK-DO 30
Secondary ID FK-DO 10/020
Status Completed
Phase N/A
First received January 29, 2010
Last updated August 15, 2014
Start date May 2010
Est. completion date September 2012

Study information

Verified date August 2014
Source Kovacs Foundation
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Back Pain Research Network
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 461
Est. completion date September 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Education on active management
Routine clinical practice plus education on active management.
Other:
Group GDS physiotherapy
Routine clinical practice (which will be substituted by Group GDS) plus education on active management.
Individual GDS physiotherapy
Routine clinical practice (except for usual physiotherapy, which is substituted by Group and Individual GDS) plus education on active management.

Locations

Country Name City State
Spain Areas Nº 1 and 11. Primary Care. Spanish National Health Service in Madrid (SERMAS) Madrid

Sponsors (1)

Lead Sponsor Collaborator
Kovacs Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. Epub 2004 Sep 17. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Low back pain, referred pain and disability Baseline, 2, 6 and 12 months No
Secondary 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 No
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