NCT05423509

Myofascial and Articular Treatment of Adolescent Idiopathic Scoliosis

Completed NA Results posted Last updated 11 June 2024

What this trial tests

NA trial testing Dynamic myofascial manipulation in Scoliosis Idiopathic Adolescent Treatment in 21 participants. Completed in 10 June 2022.

Timeline

1 December 2020

Primary endpoint
31 January 2022

10 June 2022

Quick facts

Lead sponsor	University of New Mexico
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	21
Start date	1 December 2020
Primary completion	31 January 2022
Estimated completion	10 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Dynamic myofascial manipulation
• Standard AIS treatment with observation or bracing

Conditions studied

• Scoliosis Idiopathic Adolescent Treatment — all drugs for Scoliosis Idiopathic Adolescent Treatment →

Sponsor

University of New Mexico

Who can join

Adults 10 to 15, any sex, with Scoliosis Idiopathic Adolescent Treatment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cobb Angle Primary · At time of enrollment

Cobb angle as measured on x-ray

Group	Value	95% CI
Standard Treatment for AIS	18.9	15 – 23
Treatment With Dynamic Myofascial Manipulation	23.8	14.6 – 33

Cobb Angle Primary · 6 months from time of enrollment

Cobb angle as measured on x-ray

Group	Value	95% CI
Standard Treatment for AIS	21.3	± 6.3
Treatment With Dynamic Myofascial Manipulation	25.3	± 12.9

Scoliometer Degree Primary · At time of enrollment

The degree of rotation measured clinically with a scoliometer

Group	Value	95% CI
Standard Treatment for AIS	7.4	± 3.3
Treatment With Dynamic Myofascial Manipulation	8.1	± 4.4

SRS-22 Primary · At time of enrollment

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, Posit

Group	Value	95% CI
Standard Treatment for AIS	84.2	± 10.1
Treatment With Dynamic Myofascial Manipulation	85.1	± 11.8

SRS-22 Primary · 6 months from time of enrollment

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, Posit

Group	Value	95% CI
Standard Treatment for AIS	80.9	± 10.2
Treatment With Dynamic Myofascial Manipulation	89.1	± 8.6

Pain Scale Primary · At time of enrollment

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.

Group	Value	95% CI
Standard Treatment for AIS	2	± 2.5
Treatment With Dynamic Myofascial Manipulation	2.2	± 2.1

Pain Scale Primary · 6 months from time of enrollment

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.

Group	Value	95% CI
Standard Treatment for AIS	2.9	± 2.5
Treatment With Dynamic Myofascial Manipulation	1.1	± 1.7

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.