Body Structure and Capacity Evaluation of Adults With Scoliosis (NCT05538871) | Clinical Trial Compass
RecruitingNot Applicable
Body Structure and Capacity Evaluation of Adults With Scoliosis
Canada108 participantsStarted 2019-05-06
Plain-language summary
Adults with scoliosis have not been the focus of much research in physical therapy despite their prevalence being very important. Adults with idiopathic scoliosis have a reported prevalence of about 2-11%. This includes adolescents with idiopathic scoliosis who have become adults but still have a scoliosis. They do not get much treatment as the adolescent treatment focuses on preventing worsening of the curvatures and the risk of progression is significantly reduced once a person reaches skeletal maturity. Still some patients experience self-image, function and pain issues which may be amenable to treatment using specific exercises as was recently shown. With ageing population a growing number of adults with de novo degenerative scoliosis is observed. This is a spinal misalignment due to spine degeneration. Adult degenerative scoliosis with pain is thought to affect about 24% of the ageing adults. This population has not been investigated very much.
Before planning conservative treatments for adults with scoliosis it would be important to describe what deficit these adults present that may be targeted by physical therapy. The objective of this study is to compare samples of patients with adults degenerative scoliosis, adult idiopathic scoliosis to matched healthy controls (for age, height and weight). Participants will complete questionnaires and a physical exam to identify which limitations they present that may be amenable to treatment with physical therapy. This information will assist planning trials to address the needs of these two neglected patient populations.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria for the idiopathic scoliosis group :
* Diagnosis of idiopathic scoliosis
* Age ⩾18 years old
* Curve severity over 10°
* Fluent in English.
Inclusion criteria for the degenerative scoliosis group :
* Diagnosis of degenerative (De novo) scoliosis
* Age ⩾45 years old
* Curve severity over 10°
* Fluent in English.
Exclusion criteria for the scoliosis groups :
* History of spine surgery or
* History of diseases affecting the torso or lower extremity function
* Surgery or trauma
* Secondary scoliosis
* Unable to fill out the questionnaires or attend the physical examination,
* Pregnant or gave birth between 0 and 2 years ago.
Inclusion criteria for healthy groups:
* Age ⩾ 18 years
* Matched for age/height/weight (+/-5 years; +/- 10 lbs; +/- 10cm) to a scoliosis participant
* Fluent in English
Exclusion criteria for healthy groups:
* Serious systemic pathology
* Spine deformity
* Spine surgery
* Pregnant or gave birth between 0 and 2 years ago
* Unable to fill out the questionnaires or attend the physical examination
* Received treatments for the spine/the lower limbs within the last year
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.