Myofascial and Articular Treatment of Adolescent Idiopathic Scoliosis
Primary Purpose
Scoliosis Idiopathic Adolescent Treatment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dynamic myofascial manipulation
Standard AIS treatment with observation or bracing
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis Idiopathic Adolescent Treatment focused on measuring scoliosis, adolescent, chiropractor, myofascial, idiopathic
Eligibility 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
Sites / Locations
- UNM Carrie Tingley Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Standard treatment for AIS
Treatment with Dynamic Myofascial Manipulation
Arm Description
These are the participants with AIS that recieved the standard treatment with observation or bracing depending on the size of their curve.
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
Outcomes
Primary Outcome Measures
Cobb angle
Cobb angle as measured on x-ray
Cobb angle
Cobb angle as measured on x-ray
Scoliometer degree
The degree of rotation measured clinically with a scoliometer
Scoliometer degree
The degree of rotation measured clinically with a scoliometer
SRS-22
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
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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05423509
First Posted
June 1, 2022
Last Updated
July 29, 2022
Sponsor
University of New Mexico
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT05423509
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
June 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic Adolescent Treatment
Keywords
scoliosis, adolescent, chiropractor, myofascial, idiopathic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial between 2 treatment groups
Masking
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.
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard treatment for AIS
Arm Type
Other
Arm Description
These are the participants with AIS that recieved the standard treatment with observation or bracing depending on the size of their curve.
Arm Title
Treatment with Dynamic Myofascial Manipulation
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Dynamic myofascial manipulation
Intervention Description
Dynamic myofascial manipulation of the muscles in the back to improve the scoliosis appearance/flexibility/rotation
Intervention Type
Other
Intervention Name(s)
Standard AIS treatment with observation or bracing
Intervention Description
Observation with radiographs and bracing of curves greater than 20 degrees
Primary Outcome Measure Information:
Title
Cobb angle
Description
Cobb angle as measured on x-ray
Time Frame
At time of enrollment
Title
Cobb angle
Description
Cobb angle as measured on x-ray
Time Frame
6 months from time of enrollment
Title
Scoliometer degree
Description
The degree of rotation measured clinically with a scoliometer
Time Frame
At time of enrollment
Title
Scoliometer degree
Description
The degree of rotation measured clinically with a scoliometer
Time Frame
6 months from time of enrollment
Title
SRS-22
Description
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.
Time Frame
At time of enrollment
Title
SRS-22
Description
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.
Time Frame
6 months from time of enrollment
Title
Pain scale
Description
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.
Time Frame
At time of enrollment
Title
Pain scale
Description
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.
Time Frame
6 months from time of enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
UNM Carrie Tingley Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Myofascial and Articular Treatment of Adolescent Idiopathic Scoliosis
We'll reach out to this number within 24 hrs