Myofascial and Articular Treatment of Adolescent Idiopathic Scoliosis

NCT05423509 | Completed Results

• 1 other identifier: Study 20-228
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis Idiopathic Adolescent Treatment

Keywords

scoliosis; adolescent; chiropractor; myofascial; idiopathic

Outcome Measures

Primary Outcomes (7)

• Cobb Angle

  Cobb angle as measured on x-ray

  At time of enrollment

• Cobb Angle

  Cobb angle as measured on x-ray

  6 months from time of enrollment

• Scoliometer Degree

  The degree of rotation measured clinically with a scoliometer

  At time of enrollment

• 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.

  At time of enrollment

• 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.

  6 months from time of enrollment

• 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.

  At time of enrollment

• 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.

  6 months from time of enrollment

Study Arms (2)

Standard treatment for AIS

OTHER

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

Treatment with Dynamic Myofascial Manipulation

EXPERIMENTAL

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; Other: Standard AIS treatment with observation or bracing

Interventions

Dynamic myofascial manipulation OTHER

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

Treatment with Dynamic Myofascial Manipulation

Standard AIS treatment with observation or bracing OTHER

Observation with radiographs and bracing of curves greater than 20 degrees

Standard treatment for AIS; Treatment with Dynamic Myofascial Manipulation

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• outside of age range, cobb angle or maturity level

Sponsors & Collaborators

• University of New Mexico: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

UNM Carrie Tingley Hospital

Albuquerque, New Mexico, 87102, United States

Location

MeSH Terms

Conditions

Scoliosis

Interventions

Observation; Braces

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Selina Silva, MD
• Organization: University of New Mexico Health System

ssilva@salud.unm.edu

505-272-4107

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The follow-up visits were performed by an advanced practice provider that did not know which treatment arm the patient is in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Orthopaedic Surgerey

Model Details: randomized controlled trial between 2 treatment groups

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 21, 2022
• Study Start: December 1, 2020
• Primary Completion: January 31, 2022
• Study Completion: June 10, 2022
• Last Updated: June 11, 2024
• Results First Posted: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)