Subacute Nonspecific Low Back PainNCT01060280
Effectiveness of Group GDS and Individual GDS for Treatment of Low Back Pain in Primary Care
A study testing Education on active management, Group GDS physiotherapy and Individual GDS physiotherapy in people with Subacute Nonspecific Low Back Pain and Chronic Nonspecific Low Back Pain, run by Kovacs Foundation at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subacute Nonspecific Low Back Pain, Chronic Nonspecific Low Back Pain
- What is being tested?
- Education on active management, Group GDS physiotherapy and Individual GDS physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 1 siteSpain
- Study dates
- May 2010to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Areas Nº 1 and 11. Primary Care. Spanish National Health Service in Madrid (SERMAS)
Madrid, Madrid, 28016
About this study
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.
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.
- Being tested
- Education on active management, Group GDS physiotherapy, Individual GDS physiotherapy
- Keywords
- low back pain, physiotherapy, exercise, active management
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education on active managementBehavioural
Routine clinical practice plus education on active management.
Group GDS physiotherapyOther
Routine clinical practice (which will be substituted by Group GDS) plus education on active management.
Individual GDS physiotherapyOther
Routine clinical practice (except for usual physiotherapy, which is substituted by Group and Individual GDS) plus education on active management.
| Study group | Role | What they receive |
|---|---|---|
| Education group | Active comparator | Routine clinical practice (includes usual physiotherapy)plus education on active management. Receives: Behavioral: Education on active management; Other: Group GDS physiotherapy; Other: 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. Receives: Other: Group GDS physiotherapy; Other: 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. Receives: Other: Individual GDS physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain, referred pain and disability
Measured: 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
Measured: Baseline, 2, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Subacute Nonspecific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco M. Kovacs, Kovacs Foundation
- Investigators
- Francisco M Kovacs, MD, PhD, Study director, Kovacs Foundation, Palma de Mallorca, SpainMario Gestoso, MD, Principal investigator, Kovacs Foundation, Palma de Mallorca, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060280
- Sponsor's protocol ID
- FK-DO 30
- Other IDs
- FK-DO 10/020
- Status last verified
- Aug 2014
- First submitted
- 29 Jan 2010
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15377573Rivero-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.
PubMed 16721304Little 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.
PubMed 18713809Diaz-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.
PubMed 25359444
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01060280
- Acronym / sponsor ID
- FK-DO 30
- Keywords
- low back pain, physiotherapy, exercise, active management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education group | Active comparator | Behavioral: Education on active management, Other: Group GDS physiotherapy, Other: Individual GDS physiotherapyRoutine clinical practice (includes usual physiotherapy)plus education on active management. |
| Group GDS physiotherapy | Active comparator | Other: Group GDS physiotherapy, Other: Individual GDS physiotherapyRoutine clinical practice (except usual physiotherapy, which is substituted for Group GDS)plus education on active management. |
| Individual GDS physiotherapy | Active comparator | Other: Individual GDS physiotherapyRoutine clinical practice (except for usual physiotherapy, which will be substituted by Group and Individual GDS) plus education on active management. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education on active managementRoutine clinical practice plus education on active management. | Behavioural | Education group |
| Group GDS physiotherapyRoutine clinical practice (which will be substituted by Group GDS) plus education on active management. | Other | Education group, Group GDS physiotherapy |
| Individual GDS physiotherapyRoutine clinical practice (except for usual physiotherapy, which is substituted by Group and Individual GDS) plus education on active management. | Other | Education group, Group GDS physiotherapy, Individual GDS physiotherapy |
Primary outcome
Low back pain, referred pain and disability
Time frame: Baseline, 2, 6 and 12 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
- Background: PubMed 15377573Frost 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.
- Background: PubMed 16721304Rivero-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.
- Background: PubMed 18713809Little 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.
- Derived from this study: PubMed 25359444Diaz-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco M Kovacs, MD, PhD study director
Kovacs Foundation, Palma de Mallorca, Spain
Mario Gestoso, MD principal investigator
Kovacs Foundation, Palma de Mallorca, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education on active management, Group GDS physiotherapy and Individual GDS physiotherapy in people with Subacute Nonspecific Low Back Pain and Chronic Nonspecific Low Back Pain, run by Kovacs Foundation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low back pain, referred pain and disability (time frame: Baseline, 2, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01060280, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2014.