Low Back PainPhase 2GDSNCT00624533
Efficiency of GDS Method for Lumbar Stabilization for Non-Specific Low Back Pain in Primary Care
A Phase 2 study testing GDS Method (muscular chains physical therapy method) and Conventional Physical Therapy in Primary Health Care in people with Low Back Pain, run by Carlos III Health Institute at 1 site in Spain.
Trial summary
The purpose of this randomized controlled trial was to assess the effectiveness of GDS Treatment Method for patients with subacute or chronic non-specific low back pain in Primary Care of Spanish National Health Service. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- GDS Method (muscular chains physical therapy method) and Conventional Physical Therapy in Primary Health Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2006to Oct 2006
- Phase
- Phase 2
- 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
- Participants were required to:
- Be aged 18 years or older;
- Have been diagnosed with simple mechanical LBP by their doctor and prescribed physiotherapy;
- Have an impairment secondary to functional overload and/or poor postural habits (patients with certain occupations were excluded if these could act as confounding factors);
- Not be receiving any other form of treatment;
- Not be neurologically compromised; and
- To be in a subacute or chronic stage of LBP exceeding 4 weeks.
Who cannot join
- Subjects were excluded if they:
- Showed clear symptoms of depression;
- Refused to participate;
- Did not sign the informed consent form;
- Had any cognitive impairment that would prevent them from following instructions;
- Were unable to understand Spanish sufficiently to adequately follow instructions;
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- Had the intention of moving from the area;
- Had any form of contraindication to the physiotherapeutic techniques to be applied to both groups;
- Had red flags, or warning signs, of serious illness such as cancer, infection, fracture or cauda equinal syndrome;
- Had yellow flags, or risk factors, for a psychological disorder or had lumbar pain whose main cause was not mechanical.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficiency of Physiotherapeutic Treatment of Non-Specific Low Back Pain in Primary Care Centers Through GDS Techniques for Articular and Muscular Chains
The purpose of this randomized controlled trial was to assess the effectiveness of GDS Treatment Method for patients with subacute or chronic non-specific low back pain in Primary Care of Spanish National Health Service.
Read the detailed description
Low back pain is one of the most frequent ailments in industrialized countries, with a lifetime prevalence of more than 70%. It is responsible for a major portion of work absenteeism and is actually among those conditions which generate the greatest expense due to health and labor costs.
The Spanish National Health Service is a universal and free health care system. Non-specific low back pain (LBP) is a prevalent disorder, generating large health and social costs.
There is considerable variation in LBP related clinical practice and a considerable number of clinical guidelines have been developed for the management of subacute and chronic LBP patients.
Experience in Primary Care Centers of Madrid shows that physiotherapeutic intervention based on GDS Method for Articular and Muscular Chains is an efficient technique in the treatment of patients with diagnosis of non-specific low back pain compared with conventional physiotherapy treatment in Primary Care based on electrotherapy (TENS and microwave)
Currently, no randomized studies examining the effects of this method for patients with subacute or chronic non-specific low back pain have been published.
- Conditions
- Low Back Pain
- Being tested
- GDS Method (muscular chains physical therapy method), Conventional Physical Therapy in Primary Health Care
- Keywords
- Low back Pain, Physical Therapy Modalities, Exercise Movement Techniques, Primary Health Care
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDS Method (muscular chains physical therapy method)Behavioural
Experimental group received 15 GDS method sessions based on the equilibration of articular and muscular tensions that reduced trunk and lumbopelvic stability. GDS method combine specific technics of manual therapy, spinal stabilisation and stretching exercises (4 sessions),supervised group exercise therapy (10 sessions) and home exercise programme with individualised exercises (1 session) Experimental group received 2 sessions of 50 minutes per week during 8 weeks.
Conventional Physical Therapy in Primary Health CareBehavioural
Conventional Physical Therapy in Spanish Primary Care Units are based on Electrotherapy (TENS and microwave thermotherapy) and a standard written advices. Patients received 14 sessions of 40 minutes of conventional TENS, 10 minutes of microwave thermotherapy and 1 last session of standard written advices.
Conventional Physical Therapy group received 2 sessions of 50 minutes per week during 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Primary Health Care Conventional Physiotherapy Treatment (based in electrotherapy) Receives: Behavioral: Conventional Physical Therapy in Primary Health Care |
| B | Experimental | Group B was treated with the GDS Method (muscular and articular chains physiotherapy method) Receives: Behavioral: GDS Method (muscular chains physical therapy method) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain (VAS)
Measured: At baseline, immediately after intervention,at 3-months and 6-months
Secondary outcomes (1)
Disability (Oswestry questionnaire) Quality of life (SF-36 questionnaire) Elasticity goniometric test for lumbopelvic region
Measured: At baseline, immediately after intervention,at 3-months and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startJan 2006
- Primary completionMar 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carlos III Health Institute
- Sponsor type
- Other government
- Collaborators
- Agencia Lain Entralgo, Public Health Service of Madrid
- Investigators
- José L Chicharro, MD, Principal investigator, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624533
- Sponsor's protocol ID
- PI051650
- Other IDs
- PI051650, LA2007PISINISCIII77
- Acronym
- GDS
- Status last verified
- Feb 2008
- First submitted
- 19 Feb 2008
- Last updated
- 27 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kovacs FM, Abraira V, Zamora J, Teresa Gil del Real M, Llobera J, Fernandez C, Bauza JR, Bauza K, Coll J, Cuadri M, Duro E, Gili J, Gestoso M, Gomez M, Gonzalez J, Ibanez P, Jover A, Lazaro P, Llinas M, Mateu C, Mufraggi N, Muriel A, Nicolau C, Olivera MA, Pascual P, Perello L, Pozo F, Revuelta T, Reyes V, Ribot S, Ripoll J, Ripoll J, Rodriguez E; Kovacs-Atencion Primaria Group. Correlation between pain, disability, and quality of life in patients with common low back pain. Spine (Phila Pa 1976). 2004 Jan 15;29(2):206-10. doi: 10.1097/01.BRS.0000107235.47465.08.
PubMed 14722416
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Physiotherapeutic Treatment of Non-Specific Low Back Pain in Primary Care Centers Through GDS Techniques for Articular and Muscular Chains
- ClinicalTrials.gov ID
- NCT00624533
- Acronym / sponsor ID
- GDS / PI051650
- Conditions
- Low Back Pain
- Keywords
- Low back Pain, Physical Therapy Modalities, Exercise Movement Techniques, Primary Health Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Carlos III Health InstituteOther government
- Collaborators
- Agencia Lain Entralgo, Public Health Service of Madrid
- Study start
- Jan 2006
- Primary completion
- Mar 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 27 Feb 2008 (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.
The purpose of this randomized controlled trial was to assess the effectiveness of GDS Treatment Method for patients with subacute or chronic non-specific low back pain in Primary Care of Spanish National Health Service.
Detailed description
Low back pain is one of the most frequent ailments in industrialized countries, with a lifetime prevalence of more than 70%. It is responsible for a major portion of work absenteeism and is actually among those conditions which generate the greatest expense due to health and labor costs.
The Spanish National Health Service is a universal and free health care system. Non-specific low back pain (LBP) is a prevalent disorder, generating large health and social costs.
There is considerable variation in LBP related clinical practice and a considerable number of clinical guidelines have been developed for the management of subacute and chronic LBP patients.
Experience in Primary Care Centers of Madrid shows that physiotherapeutic intervention based on GDS Method for Articular and Muscular Chains is an efficient technique in the treatment of patients with diagnosis of non-specific low back pain compared with conventional physiotherapy treatment in Primary Care based on electrotherapy (TENS and microwave)
Currently, no randomized studies examining the effects of this method for patients with subacute or chronic non-specific low back pain have been published.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Behavioral: Conventional Physical Therapy in Primary Health CarePrimary Health Care Conventional Physiotherapy Treatment (based in electrotherapy) |
| B | Experimental | Behavioral: GDS Method (muscular chains physical therapy method)Group B was treated with the GDS Method (muscular and articular chains physiotherapy method) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be aged 18 years or older;
- Have been diagnosed with simple mechanical LBP by their doctor and prescribed physiotherapy;
- Have an impairment secondary to functional overload and/or poor postural habits (patients with certain occupations were excluded if these could act as confounding factors);
- Not be receiving any other form of treatment;
- Not be neurologically compromised; and
Key exclusion criteria (10 listed)
- Showed clear symptoms of depression;
- Refused to participate;
- Did not sign the informed consent form;
- Had any cognitive impairment that would prevent them from following instructions;
- Were unable to understand Spanish sufficiently to adequately follow instructions;
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 |
|---|---|---|
| GDS Method (muscular chains physical therapy method)Experimental group received 15 GDS method sessions based on the equilibration of articular and muscular tensions that reduced trunk and lumbopelvic stability. GDS method combine specific technics of manual therapy, spinal stabilisation and stretching exercises (4 sessions),supervised group exercise therapy (10 sessions) and home exercise programme with individualised exercises (1 session) Experimental group received 2 sessions of 50 minutes per week during 8 weeks. | Behavioural | B |
| Conventional Physical Therapy in Primary Health CareConventional Physical Therapy in Spanish Primary Care Units are based on Electrotherapy (TENS and microwave thermotherapy) and a standard written advices. Patients received 14 sessions of 40 minutes of conventional TENS, 10 minutes of microwave thermotherapy and 1 last session of standard written advices. Conventional Physical Therapy group received 2 sessions of 50 minutes per week during 8 weeks. | Behavioural | A |
Primary outcome
Intensity of pain (VAS)
Time frame: At baseline, immediately after intervention,at 3-months and 6-months
1 secondary outcome
Disability (Oswestry questionnaire) Quality of life (SF-36 questionnaire) Elasticity goniometric test for lumbopelvic region
Time frame: At baseline, immediately after intervention,at 3-months and 6-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 27 Feb 2008.
- Background: PubMed 14722416Kovacs FM, Abraira V, Zamora J, Teresa Gil del Real M, Llobera J, Fernandez C, Bauza JR, Bauza K, Coll J, Cuadri M, Duro E, Gili J, Gestoso M, Gomez M, Gonzalez J, Ibanez P, Jover A, Lazaro P, Llinas M, Mateu C, Mufraggi N, Muriel A, Nicolau C, Olivera MA, Pascual P, Perello L, Pozo F, Revuelta T, Reyes V, Ribot S, Ripoll J, Ripoll J, Rodriguez E; Kovacs-Atencion Primaria Group. Correlation between pain, disability, and quality of life in patients with common low back pain. Spine (Phila Pa 1976). 2004 Jan 15;29(2):206-10. doi: 10.1097/01.BRS.0000107235.47465.08.
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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.
José L Chicharro, MD principal investigator
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GDS Method (muscular chains physical therapy method) and Conventional Physical Therapy in Primary Health Care in people with Low Back Pain, run by Carlos III Health Institute 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 7 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 27 Feb 2008. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intensity of pain (VAS) (time frame: At baseline, immediately after intervention,at 3-months and 6-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 NCT00624533, which also lists 1 linked publication.
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 27 Feb 2008; AzTrials last refreshed its copy on 29 Oct 2026.