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

NCT04436003 | Completed

• 1 other identifier: 910193
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 1.To what extent were the criteria for inclusion in the study suitable?
2. 2.How did the recruitment procedure work?
3. 3.How did the participants experience GDS treatment?
4. 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. 5.How was the change in the primary outcome measure (Oswestry Disability Index)?
6. 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

Keywords

Muscle and articulation chains GDS method; pilot RCT; Oswestry Disability Index

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index

  Measures activity limitations

  4 months

Secondary Outcomes (3)

• Visual analogue scale (VAS)

  4 months

• EQ-5D-5L

  4 months

• The Keele Start Back screening tool

  4 months

Study Arms (2)

Muscle and Articulation chains GDS method treatment

EXPERIMENTAL

Participants in the intervention Group are examined and treated according to the principles of "Muscle and Articulation Chains GDS Method". They receive GDS treatment individually, up to 8 sessions of 1 hour.

Behavioral: Muscle and articulation chains GDS method

Control (treatment as usual)

NO INTERVENTION

The Control Group receives standard treatment from their RGP/ doctor. Some are prescribed physiotherapy or chiropractor treatment, or they choose their own alternatives.

Interventions

Muscle and articulation chains GDS method BEHAVIORAL

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.

Also known as: Les Chaines Musculaires et Articulaires Methode GDS

Muscle and Articulation chains GDS method treatment

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital of Vestfold: lead
• Oslo Metropolitan University: collaborator

Study Sites (1)

Vestfold Hospital

Larvik, 3257, Norway

Location

Related Publications (1)

• Diaz Arribas MJ, Ramos Sanchez M, Pardo Hervas P, Lopez Chicharro J, Angulo Carrere T, Ortega Molina P, Astasio Arbiza P. Effectiveness of the physical therapy Godelive Denys-Struyf method for nonspecific low back pain: primary care randomized control trial. Spine (Phila Pa 1976). 2009 Jul 1;34(15):1529-38. doi: 10.1097/BRS.0b013e3181aa2771.

  PMID: 19564761 RESULT

Related Links

• home page of author of books about the method
• association for practitioners

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Margreth Grotle, PhD

  Oslo Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcome assessor will be masked for randomisation. It is not possible to mask the patient and treatment provider.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: Patients are randomized into intervention or Control Group.

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 17, 2020
• Study Start: November 14, 2018
• Primary Completion: October 3, 2020
• Study Completion: October 3, 2020
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)