NCT01060280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
461

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 18, 2014

Status Verified

August 1, 2014

Enrollment Period

1.4 years

First QC Date

January 29, 2010

Last Update Submit

August 15, 2014

Conditions

Subacute Nonspecific Low Back PainChronic Nonspecific Low Back Pain

Keywords

low back painphysiotherapyexerciseactive management

Outcome Measures

Primary Outcomes (1)

  • Low back pain, referred pain and disability

    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

    Baseline, 2, 6 and 12 months

Study Arms (3)

Education group

ACTIVE COMPARATOR

Routine clinical practice (includes usual physiotherapy)plus education on active management.

Behavioral: Education on active managementOther: Group GDS physiotherapyOther: Individual GDS physiotherapy

Group GDS physiotherapy

ACTIVE COMPARATOR

Routine clinical practice (except usual physiotherapy, which is substituted for Group GDS)plus education on active management.

Other: Group GDS physiotherapyOther: Individual GDS physiotherapy

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.

Other: Individual GDS physiotherapy

Interventions

Education on active managementBEHAVIORAL

Routine clinical practice plus education on active management.

Education group
Group GDS physiotherapyOTHER

Routine clinical practice (which will be substituted by Group GDS) plus education on active management.

Education groupGroup GDS physiotherapy
Individual GDS physiotherapyOTHER

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

Education groupGroup GDS physiotherapyIndividual GDS physiotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Madrid, Madrid, 28016, Spain

Location

Related Publications (4)

  • 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.

    PMID: 15377573BACKGROUND

  • 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.

    PMID: 16721304BACKGROUND

  • 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.

    PMID: 18713809BACKGROUND

  • 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.

    PMID: 25359444DERIVED

MeSH Terms

Conditions

Low Back PainMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Francisco M Kovacs, MD, PhD

    Kovacs Foundation, Palma de Mallorca, Spain

    STUDY DIRECTOR

  • Mario Gestoso, MD

    Kovacs Foundation, Palma de Mallorca, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Scientific Department, Kovacs Foundation

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 2, 2010

Study Start

May 1, 2010

Primary Completion

October 1, 2011

Study Completion

September 1, 2012

Last Updated

August 18, 2014

Record last verified: 2014-08

Locations

ES(1)