Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis
Primary Purpose
Degenerative Scoliosis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physiotherapeutic Scoliosis Specific Exercises (PSSE)
Conventional Physical Therapy (PT)
Sponsored by
About this trial
This is an interventional supportive care trial for Degenerative Scoliosis focused on measuring Scoliosis, PSSE
Eligibility Criteria
Inclusion Criteria:
- 50+ years old
- Diagnosis of adolescent idiopathic scoliosis or adult idiopathic scoliosis; either with a Cobb angle ranging from 20-100 degrees
- Complaint of back pain that has lasted longer than 6 weeks
Exclusion Criteria:
- Any patient who has completed PSSE in the past
- Previous spinal surgery, trauma, or presence of neoplasms
- Diagnosis of congenital or neuromuscular scoliosis
- Subjects who are involved in concurrent interventions other than conventional physical therapy (PT)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
PSSE Group
Conventional PT Group
Arm Description
Individuals will receive at least 6 sessions of physiotherapeutic scoliosis specific exercises (PSSE) (Schroth) physical therapy. Patients will also be required to perform exercises 5x/wk for 15 minutes at home. Compliance will be monitored by written log and weekly phone check-in after 8 weeks.
Individuals will receive at least 6 sessions of conventional physical therapy (PT). Patients will also be required to perform exercises 5x/wk for 15 minutes at home. Compliance will be monitored by written log and weekly phone check-in after 8 weeks.
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS) Score for Back Pain
The VAS is a psychometric response scale which measures subjective characteristics or attitudes that cannot be directly measured. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Secondary Outcome Measures
Score on Scoliosis Research Society 22-item (SRS-22r)
Outcome measure designed by the Scoliosis Research Society that is specially designed for patients with scoliosis and evaluates their scores for self-image, pain, mental health, and function. It contained 22 items contributing to five main domains: Function (5 items), Pain (5 items), Self-image/appearance (5 items), Mental Health (5 items), Satisfaction with Treatment (Current/Previously performed-2 items). Scores range from 5 (best) to 1 (worst).
Score on Oswestry Disability Index (ODI)
The ODI is a self-completed questionnaire containing 10 topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03413839
Brief Title
Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis
Official Title
Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis vs Conventional Physical Therapy Exercises
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No research resources to complete study
Study Start Date
May 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pilot study to lead to a larger prospective, randomized, controlled study of older adult (ages 50 and older) spinal patients with thoracolumbar/lumbar scoliosis evaluating improvement with physiotherapeutic scoliosis-specific exercise (PSSE) compared to traditional low back physical therapy (PT).
Detailed Description
Adult scoliosis with chronic back pain is a very complex condition. Chronic back pain remains one of our country's most costly conditions to manage and treat. Many of these patients have difficulty with activities of daily living (ADL), household and community ambulation, and maintaining their professional career. The intervention options for this population remain limited, with surgery being the only one that has shown improvements in health related quality of life and an overall decrease in the complaints of pain. However, the costs of surgery and additional complications are limitations to this treatment option.There has been increased attention and interest in the medical community looking at the effects of Physiotherapeutic Scoliosis Specific Exercises (PSSE) on curve progression, improvements in health related quality of life, and pain. The investigators hypothesize that PSSE can directly affect radiological parameters, such as the sagittal vertical axis (SVA), as well as showing improvements in health related quality of life using subjective patient specific outcome measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Scoliosis
Keywords
Scoliosis, PSSE
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PSSE Group
Arm Type
Experimental
Arm Description
Individuals will receive at least 6 sessions of physiotherapeutic scoliosis specific exercises (PSSE) (Schroth) physical therapy. Patients will also be required to perform exercises 5x/wk for 15 minutes at home. Compliance will be monitored by written log and weekly phone check-in after 8 weeks.
Arm Title
Conventional PT Group
Arm Type
Other
Arm Description
Individuals will receive at least 6 sessions of conventional physical therapy (PT). Patients will also be required to perform exercises 5x/wk for 15 minutes at home. Compliance will be monitored by written log and weekly phone check-in after 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Physiotherapeutic Scoliosis Specific Exercises (PSSE)
Other Intervention Name(s)
PSSE
Intervention Description
Exercises with emphasis on trunk extensor strengthening, and teaching patient better postural strategies in supine, sidelying, sitting, standing, and dynamic movements (walking, squatting), led by a PSSE-trained physical therapist.
Intervention Type
Behavioral
Intervention Name(s)
Conventional Physical Therapy (PT)
Intervention Description
Conventional PT includes generalized pelvis, and trunk strengthening, lower extremity (LE) stretching, and use of modalities (ice and heat), iontophoresis and E-Stim.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Score for Back Pain
Description
The VAS is a psychometric response scale which measures subjective characteristics or attitudes that cannot be directly measured. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Score on Scoliosis Research Society 22-item (SRS-22r)
Description
Outcome measure designed by the Scoliosis Research Society that is specially designed for patients with scoliosis and evaluates their scores for self-image, pain, mental health, and function. It contained 22 items contributing to five main domains: Function (5 items), Pain (5 items), Self-image/appearance (5 items), Mental Health (5 items), Satisfaction with Treatment (Current/Previously performed-2 items). Scores range from 5 (best) to 1 (worst).
Time Frame
Up to 6 months
Title
Score on Oswestry Disability Index (ODI)
Description
The ODI is a self-completed questionnaire containing 10 topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
50+ years old
Diagnosis of adolescent idiopathic scoliosis or adult idiopathic scoliosis; either with a Cobb angle ranging from 20-100 degrees
Complaint of back pain that has lasted longer than 6 weeks
Exclusion Criteria:
Any patient who has completed PSSE in the past
Previous spinal surgery, trauma, or presence of neoplasms
Diagnosis of congenital or neuromuscular scoliosis
Subjects who are involved in concurrent interventions other than conventional physical therapy (PT)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Chen, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis
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