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Clinical Trials/NCT03413839
NCT03413839
Withdrawn
Not Applicable

Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis vs Conventional Physical Therapy Exercises

Columbia University0 sitesMay 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Degenerative Scoliosis
Sponsor
Columbia University
Primary Endpoint
Visual Analog Scale (VAS) Score for Back Pain
Status
Withdrawn
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2020
End Date
December 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) Score for Back Pain

Time Frame: Up 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 Outcomes

  • Score on Scoliosis Research Society 22-item (SRS-22r)(Up to 6 months)
  • Score on Oswestry Disability Index (ODI)(Up to 6 months)

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