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Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis

Not Applicable
Withdrawn
Conditions
Degenerative Scoliosis
Interventions
Behavioral: Physiotherapeutic Scoliosis Specific Exercises (PSSE)
Behavioral: Conventional Physical Therapy (PT)
Registration Number
NCT03413839
Lead Sponsor
Columbia University
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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
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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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PSSE GroupPhysiotherapeutic Scoliosis Specific Exercises (PSSE)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.
Conventional PT GroupConventional Physical Therapy (PT)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.
Primary Outcome Measures
NameTimeMethod
Visual Analog Scale (VAS) Score for Back PainUp to 2 years

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
NameTimeMethod
Score on Scoliosis Research Society 22-item (SRS-22r)Up to 6 months

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)Up to 6 months

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.

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