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Myofascial and Articular Treatment of Adolescent Idiopathic Scoliosis

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ClinicalTrials.gov Identifier: NCT05423509
Recruitment Status : Completed
First Posted : June 21, 2022
Last Update Posted : August 2, 2022
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Selina Silva, University of New Mexico

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.

Condition or disease Intervention/treatment Phase
Scoliosis Idiopathic Adolescent Treatment Other: Dynamic myofascial manipulation Other: Standard AIS treatment with observation or bracing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial between 2 treatment groups
Masking: Single (Outcomes Assessor)
Masking Description: The follow-up visits were performed by an advanced practice provider that did not know which treatment arm the patient is in.
Primary Purpose: Treatment
Official Title: Dynamic Myofascial and Articular Mobilization and Reorganization (DMAMR) Treatment in Adolescent Idiopathic Scoliosis (AIS)
Actual Study Start Date : December 1, 2020
Actual Primary Completion Date : January 31, 2022
Actual Study Completion Date : June 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
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.
Other: 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
Other: Dynamic myofascial manipulation
Dynamic myofascial manipulation of the muscles in the back to improve the scoliosis appearance/flexibility/rotation

Other: Standard AIS treatment with observation or bracing
Observation with radiographs and bracing of curves greater than 20 degrees




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. This survey has been validated in the literature. It is a 22 question survey on the functional status and pain that a patient experiences. Created by the scoliosis research society. There is a scoring rubric that goes with the survey.

  6. SRS-22 [ Time Frame: 6 months from time of enrollment ]
    Functional survey for the patient to fill out on their scoliosis. This survey has been validated in the literature. It is a 22 question survey on the functional status and pain that a patient experiences. Created by the scoliosis research society. There is a scoring rubric that goes with the survey.

  7. Pain scale [ Time Frame: At time of enrollment ]
    4 questions about their pain level using a visual analog scale of 0-10. Zero is no pain and 10 is the worst pain they have ever felt.

  8. Pain scale [ Time Frame: 6 months from time of enrollment ]
    4 questions about their pain level using a visual analog scale of 0-10. Zero is no pain and 10 is the worst pain they have ever felt.



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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05423509


Locations
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United States, New Mexico
UNM Carrie Tingley Hospital
Albuquerque, New Mexico, United States, 87102
Sponsors and Collaborators
University of New Mexico
National Institutes of Health (NIH)
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Responsible Party: Selina Silva, Associate Professor, Orthopaedic Surgerey, University of New Mexico
ClinicalTrials.gov Identifier: NCT05423509    
Other Study ID Numbers: Study 20-228
First Posted: June 21, 2022    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Selina Silva, University of New Mexico:
scoliosis
adolescent
chiropractor
myofascial
idiopathic
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases