Clinical trial NCT05538871: Body Structure and Capacity Evaluation of Adults With Scoliosis
Official title: Body Structure and Capacity Evaluation of Adults With Scoliosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Scoliosis
Keywords: Scoliosis
Degenerative scoliosis
Idiopathic scoliosis
Adult scoliosis
ICF
Deficits
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults with adult idiopathic or degenerative scoliosis consulting a surgeon.

All adults from the healthy/untreated population

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Socliosis Research Society 22-revised total score
timeFrame: baseline
Secondary outcomes:
measure: Pain intensity: Numerical rating scale
timeFrame: baseline
measure: Response to the Mechanical Diagnosis and Therapy (McKenzie) exam
timeFrame: baseline
measure: Perceived appearance
timeFrame: baseline
measure: Fear avoidance related to work and physical activity
timeFrame: baseline
measure: Function
timeFrame: baseline
measure: LBP prognosis score
timeFrame: baseline
measure: Perceived ability to work
timeFrame: baseline
measure: Physical activity level
timeFrame: baseline
measure: Posture
timeFrame: baseline
measure: Range of motion (lumbar, thoracic, lower limbs)
timeFrame: baseline
measure: Range of motion (Hip abduction, thoracic rotation)
timeFrame: baseline
measure: Range of motion (lumbar rotation)
timeFrame: baseline
measure: Sensory capacity
timeFrame: baseline
measure: Voluntary motor capacity
timeFrame: baseline
measure: Involuntary motor capacity
timeFrame: baseline
measure: Nerves tension tests
timeFrame: baseline
measure: Spirometric respiratory capacity
timeFrame: baseline
measure: Flexibility
timeFrame: baseline
measure: Prevalence of patients per potential treatment
timeFrame: baseline
measure: Prevalence of patient in each specific LBP categories
timeFrame: baseline
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta, Faculty of Rehabilitation Medicine, Dept. Physical Therapy
state: Alberta
Study officials:
affiliation: University of Alberta
name: Eric Parent, PT, PhD, Pr
role: PRINCIPAL_INVESTIGATOR
References: