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Myofascial and Articular Treatment of Adolescent Idiopathic Scoliosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 1, 2022
First Posted Date  ICMJE June 21, 2022
Last Update Posted Date August 2, 2022
Actual Study Start Date  ICMJE December 1, 2020
Actual Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2022)
  • Cobb angle [ Time Frame: At time of enrollment ]
    Cobb angle as measured on x-ray
  • Cobb angle [ Time Frame: 6 months from time of enrollment ]
    Cobb angle as measured on x-ray
  • Scoliometer degree [ Time Frame: At time of enrollment ]
    The degree of rotation measured clinically with a scoliometer
  • Scoliometer degree [ Time Frame: 6 months from time of enrollment ]
    The degree of rotation measured clinically with a scoliometer
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 13, 2022)
  • Cobb angle [ Time Frame: At time of enrollment ]
    Cobb angle as measured on x-ray
  • Cobb angle [ Time Frame: 6 months from time of enrollment ]
    Cobb angle as measured on x-ray
  • Scoliometer degree [ Time Frame: At time of enrollment ]
    The degree of rotation measured clinically with a scoliometer
  • Scoliometer degree [ Time Frame: 6 months from time of enrollment ]
    The degree of rotation measured clinically with a scoliometer
  • SRS-22 [ Time Frame: At time of enrollment ]
    functional survey for the patient to fill out on their scoliosis
  • SRS-22 [ Time Frame: 6 months from time of enrollment ]
    functional survey for the patient to fill out on their scoliosis
  • Pain scale [ Time Frame: At time of enrollment ]
    4 questions about their pain level
  • Pain scale [ Time Frame: 6 months from time of enrollment ]
    4 questions about their pain level
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myofascial and Articular Treatment of Adolescent Idiopathic Scoliosis
Official Title  ICMJE Dynamic Myofascial and Articular Mobilization and Reorganization (DMAMR) Treatment in Adolescent Idiopathic Scoliosis (AIS)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Scoliosis Idiopathic Adolescent Treatment
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Standard AIS treatment with observation or bracing
  • 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
    Interventions:
    • Other: Dynamic myofascial manipulation
    • Other: Standard AIS treatment with observation or bracing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2022)
21
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 10, 2022
Actual Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05423509
Other Study ID Numbers  ICMJE Study 20-228
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Selina Silva, University of New Mexico
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of New Mexico
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE Not Provided
PRS Account University of New Mexico
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP