Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis
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|ClinicalTrials.gov Identifier: NCT03413839|
Recruitment Status : Not yet recruiting
First Posted : January 29, 2018
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Scoliosis||Behavioral: Physiotherapeutic Scoliosis Specific Exercises (PSSE) Behavioral: Conventional Physical Therapy (PT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis vs Conventional Physical Therapy Exercises|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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.
Behavioral: 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.
Other Name: PSSE
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.
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.
- 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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413839
|Contact: Prachi Bakarania, DPTemail@example.com|
|United States, New York|
|Columbia University Medical Center||Not yet recruiting|
|New York, New York, United States, 10032|
|Contact: Allen Chen, MD, MPH 212-305-3535 firstname.lastname@example.org|
|Principal Investigator:||Allen Chen, MD, MPH||Columbia University|