Effectiveness of Group GDS and Individual GDS for Treatment of Low Back Pain in Primary Care
Primary Purpose
Subacute Nonspecific Low Back Pain, Chronic Nonspecific Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Education on active management
Group GDS physiotherapy
Individual GDS physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Subacute Nonspecific Low Back Pain focused on measuring low back pain, physiotherapy, exercise, active management
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
Sites / Locations
- Areas Nº 1 and 11. Primary Care. Spanish National Health Service in Madrid (SERMAS)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Education group
Group GDS physiotherapy
Individual GDS physiotherapy
Arm Description
Routine clinical practice (includes usual physiotherapy)plus education on active management.
Routine clinical practice (except usual physiotherapy, which is substituted for Group GDS)plus education on active management.
Routine clinical practice (except for usual physiotherapy, which will be substituted by Group and Individual GDS) plus education on active management.
Outcomes
Primary Outcome Measures
Low back pain, referred pain and disability
Secondary Outcome Measures
Self-reported health (PCS and MCS summaries of SF-12), and use of other pharmacologic and non-pharmacologic treatments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01060280
Brief Title
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
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kovacs Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacute Nonspecific Low Back Pain, Chronic Nonspecific Low Back Pain
Keywords
low back pain, physiotherapy, exercise, active management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
461 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education group
Arm Type
Active Comparator
Arm Description
Routine clinical practice (includes usual physiotherapy)plus education on active management.
Arm Title
Group GDS physiotherapy
Arm Type
Active Comparator
Arm Description
Routine clinical practice (except usual physiotherapy, which is substituted for Group GDS)plus education on active management.
Arm Title
Individual GDS physiotherapy
Arm Type
Active Comparator
Arm Description
Routine clinical practice (except for usual physiotherapy, which will be substituted by Group and Individual GDS) plus education on active management.
Intervention Type
Behavioral
Intervention Name(s)
Education on active management
Intervention Description
Routine clinical practice plus education on active management.
Intervention Type
Other
Intervention Name(s)
Group GDS physiotherapy
Intervention Description
Routine clinical practice (which will be substituted by Group GDS) plus education on active management.
Intervention Type
Other
Intervention Name(s)
Individual GDS physiotherapy
Intervention Description
Routine clinical practice (except for usual physiotherapy, which is substituted by Group and Individual GDS) plus education on active management.
Primary Outcome Measure Information:
Title
Low back pain, referred pain and disability
Time Frame
Baseline, 2, 6 and 12 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco M Kovacs, MD, PhD
Organizational Affiliation
Kovacs Foundation, Palma de Mallorca, Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mario Gestoso, MD
Organizational Affiliation
Kovacs Foundation, Palma de Mallorca, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Areas Nº 1 and 11. Primary Care. Spanish National Health Service in Madrid (SERMAS)
City
Madrid
ZIP/Postal Code
28016
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
15377573
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.
Results Reference
background
PubMed Identifier
16721304
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.
Results Reference
background
PubMed Identifier
18713809
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.
Results Reference
background
PubMed Identifier
25359444
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.
Results Reference
derived
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Effectiveness of Group GDS and Individual GDS for Treatment of Low Back Pain in Primary Care
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