Body Structure and Capacity Evaluation of Adults With Scoliosis

NCT ID: NCT05538871

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-06
• Study Completion Date: 2027-01-31

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).

Conditions

Scoliosis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Degenerative scoliosis

Diagnosis of degenerative (De novo) scoliosis,

Survey + Physical exam

Intervention Type: DIAGNOSTIC_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

Adult idiopathic scoliosis

Diagnosis of idiopathic scoliosis,

Survey + Physical exam

Intervention Type: DIAGNOSTIC_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

Degenerative scoliosis - matched controls

Population sample matched to the degenerative scoliosis group.

Survey + Physical exam

Intervention Type: DIAGNOSTIC_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

Idiopathic scoliosis - matched controls

Population sample matched to the idiopathic scoliosis group.

Survey + Physical exam

Intervention Type: DIAGNOSTIC_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

Interventions

Survey + Physical exam

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Parent, PT, PhD, Pr

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta, Faculty of Rehabilitation Medicine, Dept. Physical Therapy

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Eric Parent, PT, PhD, Pr

Role: CONTACT

eparent@ualberta.ca

+1 780-492-8889

Facility Contacts

Eric C Parent, PhD

Role: primary

eparent@ualberta.ca

780-492-8889

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00089305

Identifier Type: -

Identifier Source: org_study_id