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

NCT04436003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-08-30

No results posted yet for this study

Summary

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.

Conditions

  • Low Back Pain, Recurrent
  • Degenerative Disc Disease

Interventions

BEHAVIORAL

Muscle and articulation chains GDS method

A physiotherapy method adapting treatment to patient's "terrain", or psychomorphology, using chosen techniques to balance tension between muscle chains, thus optimalizing posture and mouvement.

Sponsors & Collaborators

  • Oslo Metropolitan University

    collaborator OTHER

  • The Hospital of Vestfold

    lead OTHER

Principal Investigators

  • Margreth Grotle, PhD · Oslo Metropolitan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-14
Primary Completion
2020-10-03
Completion
2020-10-03

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04436003 on ClinicalTrials.gov