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Myofascial and Articular Treatment of Adolescent Idiopathic Scoliosis

Dynamic Myofascial and Articular Mobilization and Reorganization (DMAMR) Treatment in Adolescent Idiopathic Scoliosis (AIS)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05423509
Enrollment
21
Registered
2022-06-21
Start date
2020-12-01
Completion date
2022-06-10
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis Idiopathic Adolescent Treatment

Keywords

scoliosis, adolescent, chiropractor, myofascial, idiopathic

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.

Interventions

OTHERDynamic myofascial manipulation

Dynamic myofascial manipulation of the muscles in the back to improve the scoliosis appearance/flexibility/rotation

OTHERStandard AIS treatment with observation or bracing

Observation with radiographs and bracing of curves greater than 20 degrees

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of New Mexico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.

Intervention model description

randomized controlled trial between 2 treatment groups

Eligibility

Sex/Gender
ALL
Age
10 Years to 15 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cobb AngleAt time of enrollmentCobb angle as measured on x-ray
Scoliometer DegreeAt time of enrollmentThe degree of rotation measured clinically with a scoliometer
SRS-22At time of enrollmentThe SRS-22 or Scoliosis Research Society-22 is a 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. This survey has 5 domains that are covered with the minimum score of 22 and the maximum score of 110. The higher the score the better the patient is doing in the domains of: Activities of Daily Living, Mental Health, Pain, Patient Satisfaction, Positive Affect, Quality of Life, Social Relationships, and Stress/Coping.
Pain ScaleAt time of enrollmentQuestion asking each participant about their back pain level using a visual analog scale of 0-10. Zero is no pain and 10 is the worst pain they have ever felt.

Countries

United States

Participant flow

Participants by arm

ArmCount
Standard Treatment for Adolescent Idiopathic Scoliosis
These are the participants with Adolescent Idiopathic Scoliosis that received 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
9
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
12
Total21

Baseline characteristics

CharacteristicTreatment With Dynamic Myofascial ManipulationTotalStandard Treatment for Adolescent Idiopathic Scoliosis
Age, Categorical
<=18 years
12 Participants21 Participants9 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous12.5 years12.5 years12.5 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants2 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
10 Participants19 Participants9 Participants
Region of Enrollment
United States
12 participants21 participants9 participants
Sex: Female, Male
Female
11 Participants19 Participants8 Participants
Sex: Female, Male
Male
1 Participants2 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 12
other
Total, other adverse events
0 / 90 / 12
serious
Total, serious adverse events
0 / 90 / 12

Outcome results

Primary

Cobb Angle

Cobb angle as measured on x-ray

Time frame: At time of enrollment

Population: We did not have as many patients enroll as originally expected because of COVID

ArmMeasureValue (MEAN)
Standard Treatment for AISCobb Angle18.9 degrees
Treatment With Dynamic Myofascial ManipulationCobb Angle23.8 degrees
Primary

Cobb Angle

Cobb angle as measured on x-ray

Time frame: 6 months from time of enrollment

ArmMeasureValue (MEAN)Dispersion
Standard Treatment for AISCobb Angle21.3 degreesStandard Deviation 6.3
Treatment With Dynamic Myofascial ManipulationCobb Angle25.3 degreesStandard Deviation 12.9
Primary

Pain Scale

Question asking each participant about their back 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

Population: When asking about their back pain specifically.

ArmMeasureValue (MEAN)Dispersion
Standard Treatment for AISPain Scale2 units on a scaleStandard Deviation 2.5
Treatment With Dynamic Myofascial ManipulationPain Scale2.2 units on a scaleStandard Deviation 2.1
Primary

Pain Scale

Question asking each participant about their back 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

Population: When asking about their back pain specifically.

ArmMeasureValue (MEAN)Dispersion
Standard Treatment for AISPain Scale2.9 score on a scaleStandard Deviation 2.5
Treatment With Dynamic Myofascial ManipulationPain Scale1.1 score on a scaleStandard Deviation 1.7
Primary

Scoliometer Degree

The degree of rotation measured clinically with a scoliometer

Time frame: At time of enrollment

Population: We did not have the scoliosis reading on one patient in the beginning visit for the control group.

ArmMeasureValue (MEAN)Dispersion
Standard Treatment for AISScoliometer Degree7.4 degreesStandard Deviation 3.3
Treatment With Dynamic Myofascial ManipulationScoliometer Degree8.1 degreesStandard Deviation 4.4
Primary

SRS-22

The SRS-22 or Scoliosis Research Society-22 is a 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. This survey has 5 domains that are covered with the minimum score of 22 and the maximum score of 110. The higher the score the better the patient is doing in the domains of: Activities of Daily Living, Mental Health, Pain, Patient Satisfaction, Positive Affect, Quality of Life, Social Relationships, and Stress/Coping.

Time frame: At time of enrollment

Population: This is the number of participants in each group and the outcome measure numbers represent the baseline or SRS-22 scores at the time of enrollment.

ArmMeasureValue (MEAN)Dispersion
Standard Treatment for AISSRS-2284.2 units on a scaleStandard Deviation 10.1
Treatment With Dynamic Myofascial ManipulationSRS-2285.1 units on a scaleStandard Deviation 11.8
Primary

SRS-22

The SRS-22 or Scoliosis Research Society-22 is a 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. This survey has 5 domains that are covered with the minimum score of 22 and the maximum score of 110. The higher the score the better the patient is doing in the domains of: Activities of Daily Living, Mental Health, Pain, Patient Satisfaction, Positive Affect, Quality of Life, Social Relationships, and Stress/Coping.

Time frame: 6 months from time of enrollment

Population: This is their SRS-22 scores 6 months into the study for each treatment group.

ArmMeasureValue (MEAN)Dispersion
Standard Treatment for AISSRS-2280.9 units on a scaleStandard Deviation 10.2
Treatment With Dynamic Myofascial ManipulationSRS-2289.1 units on a scaleStandard Deviation 8.6

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026