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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Withdrawn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
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Degenerative Scoliosis focused on measuring Scoliosis, PSSE

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 22, 2018
    Last Updated
    October 2, 2019
    Sponsor
    Columbia University
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    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
    Citations:
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    23561557
    Citation
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    Citation
    Monticone M, Ambrosini E, Cazzaniga D, Rocca B, Motta L, Cerri C, Brayda-Bruno M, Lovi A. Adults with idiopathic scoliosis improve disability after motor and cognitive rehabilitation: results of a randomised controlled trial. Eur Spine J. 2016 Oct;25(10):3120-3129. doi: 10.1007/s00586-016-4528-y. Epub 2016 Mar 25.
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    PubMed Identifier
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    Bridwell KH, Glassman S, Horton W, Shaffrey C, Schwab F, Zebala LP, Lenke LG, Hilton JF, Shainline M, Baldus C, Wootten D. Does treatment (nonoperative and operative) improve the two-year quality of life in patients with adult symptomatic lumbar scoliosis: a prospective multicenter evidence-based medicine study. Spine (Phila Pa 1976). 2009 Sep 15;34(20):2171-8. doi: 10.1097/BRS.0b013e3181a8fdc8.
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