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OpenTrials
Completed

NCT Number: NCT01060280

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

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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Key information

Conditions

Subacute Nonspecific Low Back Pain Back Pain Behavior Chronic Nonspecific Low Back Pain Low Back Pain Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Areas Nº 1 and 11. Primary Care. Spanish National Health Service in Madrid (SERMAS)

Madrid, 28016, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education on active management

Behavioral

Routine clinical practice plus education on active management.

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.

Primary outcomes

  1. Low back pain, referred pain and disability

    Time frame: Baseline, 2, 6 and 12 months

Secondary outcomes

  1. Self-reported health (PCS and MCS summaries of SF-12), and use of other pharmacologic and non-pharmacologic treatments

    Time frame: Baseline, 2, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Kovacs Foundation

Other

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Feb 2, 2010
Registry last updated
Aug 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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