ScoliosisNCT05538871
Body Structure and Capacity Evaluation of Adults With Scoliosis
An observational study of Scoliosis, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scoliosis
- What is being tested?
- Survey + Physical exam
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- 6 May 2019to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All adults with adult idiopathic or degenerative scoliosis consulting a surgeon. All adults from the healthy/untreated population
Who may be able to join
- Diagnosis of idiopathic scoliosis
- Age ⩾18 years old
- Curve severity over 10°
- Fluent in English.
- Diagnosis of degenerative (De novo) scoliosis
- Age ⩾45 years old
Show all 11Show fewer
- Curve severity over 10°
- Fluent in English.
- Age ⩾ 18 years
- Matched for age/height/weight (+/-5 years; +/- 10 lbs; +/- 10cm) to a scoliosis participant
- Fluent in English
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta, Faculty of Rehabilitation Medicine, Dept. Physical Therapy
Edmonton, Alberta, T6G2G4
Eric C Parent, PhD, 780-492-8889, eparent@ualberta.ca
Eric C Parent, PhD, PT
About this study
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.
Read the detailed description
Study design: A cross sectional study will be undertaken.
Participants will complete 45 minutes of questionnaires online using REDCAP then complete a physical exam for 1h15 including assessment of the posture, flexibility of the spine and lower extremity, neurological function, response to pain provocation test of the spine, pelvis and hips and tests of pulmonary function.
Sample size: A 0.8 point difference is expected between the expected score in the healthy groups (of 4.5) and the score in the scoliosis groups (expected scores of 3.7) on the SRS 22 with an expected SD of 1 in each group. With alpha=0.0167 (corrected for multiple comparisons) and beta=0.8 using an unilateral test needed 27 patients per group for a paired t test analysis.
Assessment methodology: Participants will bring their last X-ray and will fill out a survey and have a physical exam.
-Analysis : The population will be described with averages and standard deviations for the continuous data and frequencies with confidence intervals for the categorical.
Comparisons between groups: the continuous data among the 3 groups will be compared with paired and unpaired t test using Bonferroni post hoc comparison. Categorical data will be compared between groups with a Chi2 test (2 by 2).
References (see uploaded protocol).
- Conditions
- Scoliosis
- Being tested
- Survey + Physical exam
- Keywords
- Scoliosis, Degenerative scoliosis, Idiopathic scoliosis, Adult scoliosis, ICF, Deficits
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey + Physical examDiagnostic test
Survey:
Demographic data Pain Oswestry disability index International Physical Activity Questionnaire Scoliosis Research Society (SRS-22r) Spinal appearance questionnaire Fear Avoidance and Beliefs Questionnaire Short Orebro musculoskeletal pain questionnaire Work Ability Index
Physical exam:
Repeated movements (MDT) Posture ROM Neuro Updated treatment based classification tests Pathoanatomical classification tests
| Study group | Role | What they receive |
|---|---|---|
| Degenerative scoliosis | Diagnosis of degenerative (De novo) scoliosis, Receives: Diagnostic Test: Survey + Physical exam | |
| Adult idiopathic scoliosis | Diagnosis of idiopathic scoliosis, Receives: Diagnostic Test: Survey + Physical exam | |
| Degenerative scoliosis - matched controls | Population sample matched to the degenerative scoliosis group. Receives: Diagnostic Test: Survey + Physical exam | |
| Idiopathic scoliosis - matched controls | Population sample matched to the idiopathic scoliosis group. Receives: Diagnostic Test: Survey + Physical exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socliosis Research Society 22-revised total score
The SRS-22r is a quality of life questionnaire which consists of 22 questions assessing 5 quality of life domains: Function, Pain, Self-Image, Mental health (5 questions), satisfaction (2 questions). Each category is rated on 5. The categories are summed and divided by 5 to have a total score on 5 points. 5 is the best score and 1 the worst
Measured: baseline
Secondary outcomes (20)
Pain intensity: Numerical rating scale
Numerical rating scale from 0 to 10 where 0 is no pain and 10 the Worst imaginable pain. The patient has to select between: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10. The value will be recorded separately for thoracic pain, lumbar pain and leg pain at the best, worse and current levels over the last 24 hours. All these scores are averaged for a total score.
Measured: baseline
Response to the Mechanical Diagnosis and Therapy (McKenzie) exam
A repeated movement exam according to MDT will be completed to note centralisation, peripheralization , and detect directional preference. The patient will be asked to perform 10 repeated movements in flexion, extension, lateral side glides direction and the participant will be asked to report if symptoms became more proximal (centralisation), more distal (peripheralization) better or worse or if there was no change after the repetitions. The direction identified as providing centralization or the best pain response will be identified as the directional preference.
Measured: baseline
Perceived appearance
The Spinal Appearance Questionnnaire (SAQ) consists of 11 pictogram questions and 12 multiple choice questions and an open question to assess the perceived appearance. A perceived appearance score (10-50) and an expectation score 4-20 will be calculated by averaging relevant items. A low score indicate good perceived appearance /50 and expectation /20.
Measured: baseline
Fear avoidance related to work and physical activity
Fear Avoidance and Beliefs Questionnaire (FABQ). The FABQ was developed on the basis of the assumption that fear-avoidance beliefs play a major role in LBP-related disability. It comprises 16 items scored by the patient and includes sub-scores for fear-avoidance beliefs regarding work (0-42) and physical activity (0-24). A higher score indicates more strongly held fear avoidance beliefs.
Measured: baseline
Function
Oswestry Disability Index (ODI). The ODI uses 10 questions with 5 answer options to assess the degree of disability associated with spinal disorders. The total score is out of 100 starting with 0. High score indicate high disability.
Measured: baseline
LBP prognosis score
The modified Orebro Musculoskeletal Pain questionnaire (short version) is a 12 items questionnaire which assess pain and psycho social factors. 100 is the worst score and 0 the best.
Measured: baseline
Perceived ability to work
Work Ability Index is a 5 items questionnaire which assess the perceived ability to work. 38 is the best and 5 the worst.
Measured: baseline
Physical activity level
The International Physical Activity Questionnaire (short) assesses the time spent per the participant to do different level of physical activity during a week in minutes. The time spent at each activity levels is converted to a MET score for the each patient. High MET indicate more physical activity was performed.
Measured: baseline
Posture
Photographies with landmarks: Posture photographs of the front and back and side profile of the participants will be collected to later extract the Posterior and Anterior Trunk Symmetry Indices (POTSI and ATSI). A plumbline and a flexicurve are used to assess the curves. High POTSI and ATSI scores indicate large deformity. High kyphosis and lordosis indices indicate hyperkyphosis and lordosis respectively.
Measured: baseline
Range of motion (lumbar, thoracic, lower limbs)
Inclinometer to measure Range of motion in degree, the measurement of the lumbar flexion, extension and lateral flexion between T12L1 and S1 and the measurement of the thoracic flexion, extension and lateral flexion will be captured in degrees with double inclinometer technique between C7T1 and T12L1. The hip flexion is measured with the inclinometer on the front part of the tight. The straight leg raise and the prone knee bend test are measured with the single inclinometer on the front part of the ankle in both techniques. Higher degree readings indicate higher range of motion for all movements recorded with inclinometer (s).
Measured: baseline
Range of motion (Hip abduction, thoracic rotation)
Goniometer in degree. The range of each hip abduction is recorded by the goniometer. Higher degree readings indicate higher flexibility. The range of thoracic rotation between a 2 meters stick and the lateral edge of the table is recorded to the nearest degree with a goniometer to indicate full spine rotation. Higher ranges indicate more flexibility.
Measured: baseline
Range of motion (lumbar rotation)
Back Range Of Motion tool will be used to measured the degree or lumbar rotation available in the lumbar spine. Higher degrees indicate more flexiblity.
Measured: baseline
Sensory capacity
Pic/Touch sensation on the lower limbs for each dermatome from L1 to S1. The examiner assesses for each dermatome if the participant discriminate most of the time the pic and the touch sensation or not. The front hip, front tight, medial knee, medial ankle, dorsal part of the big toe, heel, and the back of the knee are tested. Responses are recorded for each dermatomes on each side as can discriminates most of the time, does not discriminate most of the time and does not fell contact.
Measured: baseline
Voluntary motor capacity
Strength of the lower limbs for each myotome from L1 to S1 measures with a dynamometer in pounds. The higher the score is higher the strength is. The hip flexion, knee extension, foot flexion/extension/eversion, and big toe extension are tested.
Measured: baseline
Involuntary motor capacity
Patellar and Achilles Reflexes (hypereactive/hyporeactive/normal) are tested with an reflexe hammer. Reported as hyper, hypo or normal.
Measured: baseline
Nerves tension tests
Prone Knee Bend (PKB) (knee flexion in a prone position) and Straight Leg Raise (SLR) (hip flexion with the knee extended in a supine position) tests. We recorde the range of motion in degree with the inclinometer and whether pain is produced pain or not by these tests.
Measured: baseline
Spirometric respiratory capacity
Spirometer volumes (in liters): vital capacity, forced expiratory vital capacity, forced expiratory vital capacity after 1 sec (FEV1), FEV1 in % of maximal vital capacity. Flows (Liter/Sec): Maximal expiratory flow, Maximal expiratory flow at 25, 50, 75 % of the vital capacity, maximal inspiration flow. Higher are the volumes and flow better it is.
Measured: baseline
Flexibility
The Beighton score is a 9 point score which assess general flexibility of the limbs (the examiner searches for any hyperextension of the elbows and the knees, the ability to touch the floor with the palms (knee extended), maximal 5th finger extension exceeding 90 dgegrees and ability to touch the forarm with the thumb. 9 is hypermobile, 0 is normal.
Measured: baseline
Prevalence of patients per potential treatment
Prevalence in each of the treatment based classification algorithm classification: manipulation, stabilisation, specific exercise. The classification is based on the clinical findings described in the other outcomes and the algorithm is followed to classify if possible the participants in these 3 treatment categories (cf Fritz Subgrouping Patients With Low Back Pain: Evolution of a Classification Approach to Physical Therapy 2007 JOSPT)
Measured: baseline
Prevalence of patient in each specific LBP categories
Patho-anatomical classification: Disc, disc+nerve root involvement, sacro iliac joint, spinal stenosis, spondylolisthesis. The research team classify (if possible) the participant in one of the categories based on the exam clinical findings(other outcomes listed above). Clinical criteria presented in Clinical classification in low back pain: best-evidence diagnostic rules based on systematic reviews by Petersen et al in 2017 are used to inform classification decisions.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start6 May 2019
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Parent, PT, PhD, Pr, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538871
- Sponsor's protocol ID
- Pro00089305
- Status last verified
- Jun 2026
- First submitted
- 3 May 2019
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Structure and Capacity Evaluation of Adults With Scoliosis
- ClinicalTrials.gov ID
- NCT05538871
- Acronym / sponsor ID
- Pro00089305
- Conditions
- Scoliosis
- Keywords
- Scoliosis, Degenerative scoliosis, Idiopathic scoliosis, Adult scoliosis, ICF, Deficits
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design: A cross sectional study will be undertaken.
Participants will complete 45 minutes of questionnaires online using REDCAP then complete a physical exam for 1h15 including assessment of the posture, flexibility of the spine and lower extremity, neurological function, response to pain provocation test of the spine, pelvis and hips and tests of pulmonary function.
Sample size: A 0.8 point difference is expected between the expected score in the healthy groups (of 4.5) and the score in the scoliosis groups (expected scores of 3.7) on the SRS 22 with an expected SD of 1 in each group. With alpha=0.0167 (corrected for multiple comparisons) and beta=0.8 using an unilateral test needed 27 patients per group for a paired t test analysis.
Assessment methodology: Participants will bring their last X-ray and will fill out a survey and have a physical exam.
-Analysis : The population will be described with averages and standard deviations for the continuous data and frequencies with confidence intervals for the categorical.
Comparisons between groups: the continuous data among the 3 groups will be compared with paired and unpaired t test using Bonferroni post hoc comparison. Categorical data will be compared between groups with a Chi2 test (2 by 2).
References (see uploaded protocol).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Degenerative scoliosis | – | Diagnostic Test: Survey + Physical examDiagnosis of degenerative (De novo) scoliosis, |
| Adult idiopathic scoliosis | – | Diagnostic Test: Survey + Physical examDiagnosis of idiopathic scoliosis, |
| Degenerative scoliosis - matched controls | – | Diagnostic Test: Survey + Physical examPopulation sample matched to the degenerative scoliosis group. |
| Idiopathic scoliosis - matched controls | – | Diagnostic Test: Survey + Physical examPopulation sample matched to the idiopathic scoliosis group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adults with adult idiopathic or degenerative scoliosis consulting a surgeon. All adults from the healthy/untreated population
Key inclusion criteria (11 listed)
- Diagnosis of idiopathic scoliosis
- Age ⩾18 years old
- Curve severity over 10°
- Fluent in English.
- Diagnosis of degenerative (De novo) scoliosis
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey + Physical examSurvey: Demographic data Pain Oswestry disability index International Physical Activity Questionnaire Scoliosis Research Society (SRS-22r) Spinal appearance questionnaire Fear Avoidance and Beliefs Questionnaire Short Orebro musculoskeletal pain questionnaire Work Ability Index Physical exam: Repeated movements (MDT) Posture ROM Neuro Updated treatment based classification tests Pathoanatomical classification tests | Diagnostic test | Adult idiopathic scoliosis, Degenerative scoliosis, Degenerative scoliosis - matched controls, Idiopathic scoliosis - matched controls |
Primary outcome
Socliosis Research Society 22-revised total score
Time frame: baseline
The SRS-22r is a quality of life questionnaire which consists of 22 questions assessing 5 quality of life domains: Function, Pain, Self-Image, Mental health (5 questions), satisfaction (2 questions). Each category is rated on 5. The categories are summed and divided by 5 to have a total score on 5 points. 5 is the best score and 1 the worst
20 secondary outcomes
Pain intensity: Numerical rating scale
Time frame: baseline
Response to the Mechanical Diagnosis and Therapy (McKenzie) exam
Time frame: baseline
Perceived appearance
Time frame: baseline
Fear avoidance related to work and physical activity
Time frame: baseline
Function
Time frame: baseline
LBP prognosis score
Time frame: baseline
Perceived ability to work
Time frame: baseline
Physical activity level
Time frame: baseline
Posture
Time frame: baseline
Range of motion (lumbar, thoracic, lower limbs)
Time frame: baseline
Range of motion (Hip abduction, thoracic rotation)
Time frame: baseline
Range of motion (lumbar rotation)
Time frame: baseline
Sensory capacity
Time frame: baseline
Voluntary motor capacity
Time frame: baseline
Involuntary motor capacity
Time frame: baseline
Nerves tension tests
Time frame: baseline
Spirometric respiratory capacity
Time frame: baseline
Flexibility
Time frame: baseline
Prevalence of patients per potential treatment
Time frame: baseline
Prevalence of patient in each specific LBP categories
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Parent, PT, PhD, Pr principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Parent, PT, PhD, Pr (+1 780-492-8889, eparent@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Socliosis Research Society 22-revised total score (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.