- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03413839
Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis
October 2, 2019 updated by: Columbia University
Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis vs Conventional Physical Therapy Exercises
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).
Study Overview
Status
Withdrawn
Conditions
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.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PSSE Group
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.
|
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.
Other Names:
|
Other: Conventional PT Group
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.
|
Conventional PT includes generalized pelvis, and trunk strengthening, lower extremity (LE) stretching, and use of modalities (ice and heat), iontophoresis and E-Stim.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score on Scoliosis Research Society 22-item (SRS-22r)
Time Frame: 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).
|
Up to 6 months
|
Score on Oswestry Disability Index (ODI)
Time Frame: 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.
|
Up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Allen Chen, MD, MPH, Columbia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bess S, Schwab F, Lafage V, Shaffrey CI, Ames CP. Classifications for adult spinal deformity and use of the Scoliosis Research Society-Schwab Adult Spinal Deformity Classification. Neurosurg Clin N Am. 2013 Apr;24(2):185-93. doi: 10.1016/j.nec.2012.12.008.
- Li G, Passias P, Kozanek M, Fu E, Wang S, Xia Q, Li G, Rand FE, Wood KB. Adult scoliosis in patients over sixty-five years of age: outcomes of operative versus nonoperative treatment at a minimum two-year follow-up. Spine (Phila Pa 1976). 2009 Sep 15;34(20):2165-70. doi: 10.1097/BRS.0b013e3181b3ff0c.
- 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.
- 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.
- Weinstein JN, Lurie JD, Tosteson TD, Zhao W, Blood EA, Tosteson AN, Birkmeyer N, Herkowitz H, Longley M, Lenke L, Emery S, Hu SS. Surgical compared with nonoperative treatment for lumbar degenerative spondylolisthesis. four-year results in the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts. J Bone Joint Surg Am. 2009 Jun;91(6):1295-304. doi: 10.2106/JBJS.H.00913.
- Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257-70. doi: 10.1056/NEJMoa070302.
- Schwab F, Dubey A, Gamez L, El Fegoun AB, Hwang K, Pagala M, Farcy JP. Adult scoliosis: prevalence, SF-36, and nutritional parameters in an elderly volunteer population. Spine (Phila Pa 1976). 2005 May 1;30(9):1082-5. doi: 10.1097/01.brs.0000160842.43482.cd.
- Kuru T, Yeldan I, Dereli EE, Ozdincler AR, Dikici F, Colak I. The efficacy of three-dimensional Schroth exercises in adolescent idiopathic scoliosis: a randomised controlled clinical trial. Clin Rehabil. 2016 Feb;30(2):181-90. doi: 10.1177/0269215515575745. Epub 2015 Mar 16.
- Negrini A, Negrini MG, Donzelli S, Romano M, Zaina F, Negrini S. Scoliosis-Specific exercises can reduce the progression of severe curves in adult idiopathic scoliosis: a long-term cohort study. Scoliosis. 2015 Jul 11;10:20. doi: 10.1186/s13013-015-0044-9. eCollection 2015.
- Negrini S, Donzelli S, Lusini M, Minnella S, Zaina F. The effectiveness of combined bracing and exercise in adolescent idiopathic scoliosis based on SRS and SOSORT criteria: a prospective study. BMC Musculoskelet Disord. 2014 Aug 6;15:263. doi: 10.1186/1471-2474-15-263.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2020
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
January 22, 2018
First Submitted That Met QC Criteria
January 22, 2018
First Posted (Actual)
January 29, 2018
Study Record Updates
Last Update Posted (Actual)
October 4, 2019
Last Update Submitted That Met QC Criteria
October 2, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAQ9761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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