GDS Muscle and Articulation Chain Treatment for Chronic LBP and Spinal Stenosis
CompletedNot applicableNCT04436003
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Our purpose is to conduct a pilot study to evaluate GDS muscle and articulation chain treatment for inoperable spine patients with degenerative changes in the lumbar spine, compared to "standard treatment" (any other chosen treatment). The pilot study will be conducted as a randomized controlled trial (RCT) to investigate feasibility and benefit of GDS muscle and articulation chain treatment on pain, function and quality of life. The pilot study will form the basis for a later full-scale randomized study and the following research questions will be addressed: 1. To what extent were the criteria for inclusion in the study suitable? 2. How did the recruitment procedure work? 3. How did the participants experience GDS treatment? 4. To what extent were the selected outcome measures suitable at the different evaluation moments, and which outcome measure tested in this pilot study would be most suitable as primary outcome measure in a full-scale study? (user experience will be included in the evaluation) 5. How was the change in the primary outcome measure (Oswestry Disability Index)? 6. What will be the estimated time for inclusion of the required number of participants in a full-scale study? (required sample size will be based on strength calculation /saving of the outcome target chosen as primary outcome measure for full scale study) The study is a pilot study with a randomized controlled design, with follow-up after 3-4 months. Thirty patients are recruited and receive baseline examination and respond to the questionnaires before randomization. The patients receive a questionnaire by mail 3-4 months after inclusion (after the treatment is completed for intervention group ). The pilot study will be one-way blinded.
Study details
- Official title
- Evaluation of "Muscle and Articulation Chains GDS Method" Treatment for Inoperable Low Back Pain Patients - a Randomised, Controlled Pilot Trial.
- Interventions
- Behavioral: Muscle and articulation chains GDS method
- Sponsor
- The Hospital of Vestfold
- Collaborators
- Oslo Metropolitan University
- Start date
- 2018-11-14
- Primary completion
- 2020-10-03
- Sex
- All
- Age range
- from 35 Years to 75 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Norway
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Men and women, age 35-75 years, with cronic (\>3 months) LBP, may have irradiation in legs. * Degenerative changes in the lumbar spine verified on MR. Exclusion Criteria: * Severe psychiatric disorder. * Comorbidity that prevents the patient from performing exercises and gradually increasing general activity when the back /leg function gradually allows it. * Already had surgery with fixation of lumbar spine. * Being in process of assessing disability insurance or economic compenastion for Health reasons. * Pregnancy
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04436003