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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic myofascial manipulation | Other | Dynamic myofascial manipulation of the muscles in the back to improve the scoliosis appearance/flexibility/rotation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNM Carrie Tingley Hospital | Albuquerque | New Mexico | 87102 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cobb Angle | Cobb angle as measured on x-ray | We did not have as many patients enroll as originally expected because of COVID | Posted | Mean | 95% Confidence Interval | degrees | At time of enrollment |
|
No adverse events occurred in either group from the time of enrollment to the time they completed the study which is a 6 month time frame.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Selina Silva, MD | University of New Mexico Health System | 505-272-4107 | ssilva@salud.unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2021 | Jun 5, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 16, 2020 | Mar 1, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| D001915 | Braces |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
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randomized controlled trial between 2 treatment groups
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The follow-up visits were performed by an advanced practice provider that did not know which treatment arm the patient is in.
| Standard AIS treatment with observation or bracing | Other | Observation with radiographs and bracing of curves greater than 20 degrees |
|
| 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 |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Cobb Angle | Cobb angle as measured on x-ray | Posted | Mean | Standard Deviation | degrees | 6 months from time of enrollment |
|
|
|
| Primary | Scoliometer Degree | The degree of rotation measured clinically with a scoliometer | We did not have the scoliosis reading on one patient in the beginning visit for the control group. | Posted | Mean | Standard Deviation | degrees | At time of enrollment |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | At time of enrollment |
|
|
|
| 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. | This is their SRS-22 scores 6 months into the study for each treatment group. | Posted | Mean | Standard Deviation | units on a scale | 6 months from time of enrollment |
|
|
|
| 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. | When asking about their back pain specifically. | Posted | Mean | Standard Deviation | units on a scale | At time of enrollment |
|
|
|
| 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. | When asking about their back pain specifically. | Posted | Mean | Standard Deviation | score on a scale | 6 months from time of enrollment |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 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 | 0 | 12 | 0 | 12 | 0 | 12 |
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| D013523 |
| Surgical Equipment |
| D004864 | Equipment and Supplies |