Clinical trial NCT03413839: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Degenerative Scoliosis
Keywords: Scoliosis
PSSE
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Visual Analog Scale (VAS) Score for Back Pain
timeFrame: Up to 2 years
Secondary outcomes:
measure: Score on Scoliosis Research Society 22-item (SRS-22r)
timeFrame: Up to 6 months
measure: Score on Oswestry Disability Index (ODI)
timeFrame: Up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Allen Chen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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