Trial Outcomes & Findings for Myofascial and Articular Treatment of Adolescent Idiopathic Scoliosis (NCT NCT05423509)
NCT ID: NCT05423509
Last Updated: 2024-06-11
Results Overview
Cobb angle as measured on x-ray
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
At time of enrollment
Results posted on
2024-06-11
Participant Flow
Participant milestones
| Measure |
Standard Treatment for AIS
These are the participants with AIS 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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
12
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Myofascial and Articular Treatment of Adolescent Idiopathic Scoliosis
Baseline characteristics by cohort
| Measure |
Standard Treatment for Adolescent Idiopathic Scoliosis
n=9 Participants
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
|
Treatment With Dynamic Myofascial Manipulation
n=12 Participants
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
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12.5 years
n=5 Participants
|
12.5 years
n=7 Participants
|
12.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At time of enrollmentPopulation: We did not have as many patients enroll as originally expected because of COVID
Cobb angle as measured on x-ray
Outcome measures
| Measure |
Standard Treatment for AIS
n=9 Participants
These are the participants with AIS 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
|
Treatment With Dynamic Myofascial Manipulation
n=12 Participants
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
|
|---|---|---|
|
Cobb Angle
|
18.9 degrees
Interval 15.0 to 23.0
|
23.8 degrees
Interval 14.6 to 33.0
|
PRIMARY outcome
Timeframe: 6 months from time of enrollmentCobb angle as measured on x-ray
Outcome measures
| Measure |
Standard Treatment for AIS
n=9 Participants
These are the participants with AIS 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
|
Treatment With Dynamic Myofascial Manipulation
n=12 Participants
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
|
|---|---|---|
|
Cobb Angle
|
21.3 degrees
Standard Deviation 6.3
|
25.3 degrees
Standard Deviation 12.9
|
PRIMARY outcome
Timeframe: At time of enrollmentPopulation: We did not have the scoliosis reading on one patient in the beginning visit for the control group.
The degree of rotation measured clinically with a scoliometer
Outcome measures
| Measure |
Standard Treatment for AIS
n=8 Participants
These are the participants with AIS 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
|
Treatment With Dynamic Myofascial Manipulation
n=12 Participants
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
|
|---|---|---|
|
Scoliometer Degree
|
7.4 degrees
Standard Deviation 3.3
|
8.1 degrees
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: At time of enrollmentPopulation: 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.
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.
Outcome measures
| Measure |
Standard Treatment for AIS
n=9 Participants
These are the participants with AIS 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
|
Treatment With Dynamic Myofascial Manipulation
n=12 Participants
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
|
|---|---|---|
|
SRS-22
|
84.2 units on a scale
Standard Deviation 10.1
|
85.1 units on a scale
Standard Deviation 11.8
|
PRIMARY outcome
Timeframe: 6 months from time of enrollmentPopulation: This is their SRS-22 scores 6 months into the study for each treatment group.
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.
Outcome measures
| Measure |
Standard Treatment for AIS
n=8 Participants
These are the participants with AIS 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
|
Treatment With Dynamic Myofascial Manipulation
n=10 Participants
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
|
|---|---|---|
|
SRS-22
|
80.9 units on a scale
Standard Deviation 10.2
|
89.1 units on a scale
Standard Deviation 8.6
|
PRIMARY outcome
Timeframe: At time of enrollmentPopulation: When asking about their back pain specifically.
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.
Outcome measures
| Measure |
Standard Treatment for AIS
n=9 Participants
These are the participants with AIS 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
|
Treatment With Dynamic Myofascial Manipulation
n=12 Participants
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
|
|---|---|---|
|
Pain Scale
|
2 units on a scale
Standard Deviation 2.5
|
2.2 units on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: 6 months from time of enrollmentPopulation: When asking about their back pain specifically.
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.
Outcome measures
| Measure |
Standard Treatment for AIS
n=8 Participants
These are the participants with AIS 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
|
Treatment With Dynamic Myofascial Manipulation
n=10 Participants
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
|
|---|---|---|
|
Pain Scale
|
2.9 score on a scale
Standard Deviation 2.5
|
1.1 score on a scale
Standard Deviation 1.7
|
Adverse Events
Standard Treatment for AIS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment With Dynamic Myofascial Manipulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Selina Silva, MD
University of New Mexico Health System
Phone: 505-272-4107
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place