GDS Muscle and Articulation Chain Treatment for Chronic LBP and Spinal Stenosis

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
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.
Epistemonikos ID: 76e72911903e1c7e9732f8e7fb6fb2194d0071f4
First added on: May 07, 2024