Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis

NCT ID: NCT03413839

Last Updated: 2019-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Degenerative Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Physiotherapeutic Scoliosis Specific Exercises (PSSE)

Intervention Type BEHAVIORAL

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.

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.

Group Type OTHER

Conventional Physical Therapy (PT)

Intervention Type BEHAVIORAL

Conventional PT includes generalized pelvis, and trunk strengthening, lower extremity (LE) stretching, and use of modalities (ice and heat), iontophoresis and E-Stim.

Interventions

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Physiotherapeutic Scoliosis Specific Exercises (PSSE)

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

Conventional Physical Therapy (PT)

Conventional PT includes generalized pelvis, and trunk strengthening, lower extremity (LE) stretching, and use of modalities (ice and heat), iontophoresis and E-Stim.

Intervention Type BEHAVIORAL

Other Intervention Names

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PSSE

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allen Chen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

References

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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.

Reference Type BACKGROUND
PMID: 23561557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19713875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27015689 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19752703 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19487505 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17538085 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15864163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25780260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26279670 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25095800 (View on PubMed)

Other Identifiers

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AAAQ9761

Identifier Type: -

Identifier Source: org_study_id

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