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History of Changes for Study: NCT05423509
Myofascial and Articular Treatment of Adolescent Idiopathic Scoliosis
Latest version (submitted July 29, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 13, 2022 None (earliest Version on record)
2 July 29, 2022 Study Status and Outcome Measures
Comparison Format:

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Study NCT05423509
Submitted Date:  June 13, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: Study 20-228
Brief Title: Myofascial and Articular Treatment of Adolescent Idiopathic Scoliosis
Official Title: Dynamic Myofascial and Articular Mobilization and Reorganization (DMAMR) Treatment in Adolescent Idiopathic Scoliosis (AIS)
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2022
Overall Status: Completed
Study Start: December 1, 2020
Primary Completion: January 31, 2022 [Actual]
Study Completion: June 10, 2022 [Actual]
First Submitted: June 1, 2022
First Submitted that
Met QC Criteria:
June 13, 2022
First Posted: June 21, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
June 13, 2022
Last Update Posted: June 21, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of New Mexico
Responsible Party: Principal Investigator
Investigator: Selina Silva
Official Title: Associate Professor, Orthopaedic Surgerey
Affiliation: University of New Mexico
Collaborators: National Institutes of Health (NIH)
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Randomized controlled trial of participants with scoliosis into standard treatment with observation/bracing and the other group will have the added treatment of dynamic myofascial manipulation for 6 months.
Detailed Description:

The purpose of this study is to conduct a pilot study of the Dynamic Myofascial and Articular Mobilization and Reorganization (DMAMR) treatment in Adolescent Idiopathic Scoliosis (AIS). The investigators propose the implementation of Dynamic Myofascial and Articular Mobilization and Reorganization (DMAMR) protocol can (a) decrease and/or reduce progression of spinal curvatures, (b) reduce degree of anatomical rib hump deformity common in AIS, (c) decrease incidence of patients requiring corrective bracing and/or corrective spinal surgery, (d) significantly reduce AIS-associated pain, and (e) improve quality of life for AIS participants.

This study will test whether DMAMR produces clinically relevant changes in progression of scoliosis curvatures and rib humps, and whether this treatment protocol improves pain scores and quality of life.

Current research has demonstrated unilateral muscle shortening in AIS. Of most importance for this research proposal, research has also identified a set of muscles, portions of which are at an angle to the spine, that are shorter on the concave side of the curvature: the quadratus lumborum, psoas major and minor, and the abdominal obliques. The researchers have suggested this is a compensatory effect of the spinal deformities seen1. The investigators agree that unilateral muscle shortening is present in AIS but the investigators suggest that this asymmetry represents differences between muscle tension on either side of the spine and results in a tethering effect on the spine itself. Supporting a finding of the importance of these muscle imbalances, research using individualized physical therapeutic exercise programs to balance these types of muscle imbalances has demonstrated effectiveness in AIS treatment.

The investigators hypothesize this asymmetrical muscle imbalance, and its resultant tethering effect on the spine, represent myofascial dysfunction. The investigators believe the forces generated by this dysfunction are sufficient to induce worsening of the AIS curvature. The myofascial factors involved in the tethering of the spine in AIS include asymmetrical muscle imbalances involving muscles at an angle to the spine, primarily iliopsoas, quadratus lumborum, abdominal obliques, latissimus dorsi, and anterior serratus muscles.

Fascia overlies and interpenetrates these muscles. At a critical point, these myofascial imbalances generate sufficient stress on the overlying fascia to create a further contractile force within the fascia itself. The investigators ask whether this contractile force is mediated not only by anatomic shortening of individual muscle groups but also by intrinsic changes in fibroblast gene expression within the fascia itself.

The investigators further hypothesize that the asymmetrical muscle imbalances observed in AIS may be part of a larger contracted fascial spiral force influencing the development and progression of deformity. Therefore, treatment of the muscles, fascia, and related articular dysfunction may contribute to the control or reduction of AIS-associated deformities including scoliotic curvatures and accompanying rib humps. Effective treatment of these imbalances and deformities may reduce or eliminate AIS-associated spinal area pain, which the investigators hypothesize is largely myofascial in nature.

Open or close this module Conditions
Conditions: Scoliosis Idiopathic Adolescent Treatment
Keywords: scoliosis
adolescent
chiropractor
myofascial
idiopathic
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
randomized controlled trial between 2 treatment groups
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 21 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Standard treatment for AIS
These are the participants with AIS that recieved the standard treatment with observation or bracing depending on the size of their curve.
Standard AIS treatment with observation or bracing
Observation with radiographs and bracing of curves greater than 20 degrees
Experimental: Treatment with Dynamic Myofascial Manipulation
These are the participants that still received the standard treatment with observation or bracing depending on the size of their curve, but also had weekly treatment with a chiropractor for 6 months for dynamic myofascial manipulation
Dynamic myofascial manipulation
Dynamic myofascial manipulation of the muscles in the back to improve the scoliosis appearance/flexibility/rotation
Standard AIS treatment with observation or bracing
Observation with radiographs and bracing of curves greater than 20 degrees
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Cobb angle
[ Time Frame: At time of enrollment ]

Cobb angle as measured on x-ray
2. Cobb angle
[ Time Frame: 6 months from time of enrollment ]

Cobb angle as measured on x-ray
3. Scoliometer degree
[ Time Frame: At time of enrollment ]

The degree of rotation measured clinically with a scoliometer
4. Scoliometer degree
[ Time Frame: 6 months from time of enrollment ]

The degree of rotation measured clinically with a scoliometer
5. SRS-22
[ Time Frame: At time of enrollment ]

functional survey for the patient to fill out on their scoliosis
6. SRS-22
[ Time Frame: 6 months from time of enrollment ]

functional survey for the patient to fill out on their scoliosis
7. Pain scale
[ Time Frame: At time of enrollment ]

4 questions about their pain level
8. Pain scale
[ Time Frame: 6 months from time of enrollment ]

4 questions about their pain level
Open or close this module Eligibility
Minimum Age: 10 Years
Maximum Age: 15 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Age from 10-15
  • Scoliosis curve of 15-30 degrees on cobb angle
  • Risser stage of 0-2

Exclusion Criteria:

  • outside of age range, cobb angle or maturity level
Open or close this module Contacts/Locations
Locations: United States, New Mexico
UNM Carrie Tingley Hospital
Albuquerque, New Mexico, United States, 87102
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services