NCT05538871

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
May 2019Jan 2027

First Submitted

Initial submission to the registry

May 3, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

May 6, 2019

Completed
3.4 years until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

7.7 years

First QC Date

May 3, 2019

Last Update Submit

May 5, 2025

Conditions

Keywords

ScoliosisDegenerative scoliosisIdiopathic scoliosisAdult scoliosisICFDeficits

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline

Secondary Outcomes (20)

  • Pain intensity: Numerical rating scale

    baseline

  • Response to the Mechanical Diagnosis and Therapy (McKenzie) exam

    baseline

  • Perceived appearance

    baseline

  • Fear avoidance related to work and physical activity

    baseline

  • Function

    baseline

  • +15 more secondary outcomes

Study Arms (4)

Degenerative scoliosis

Diagnosis of degenerative (De novo) scoliosis,

Diagnostic Test: Survey + Physical exam

Adult idiopathic scoliosis

Diagnosis of idiopathic scoliosis,

Diagnostic Test: Survey + Physical exam

Degenerative scoliosis - matched controls

Population sample matched to the degenerative scoliosis group.

Diagnostic Test: Survey + Physical exam

Idiopathic scoliosis - matched controls

Population sample matched to the idiopathic scoliosis group.

Diagnostic Test: Survey + Physical exam

Interventions

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

Adult idiopathic scoliosisDegenerative scoliosisDegenerative scoliosis - matched controlsIdiopathic scoliosis - matched controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adults with adult idiopathic or degenerative scoliosis consulting a surgeon. All adults from the healthy/untreated population

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Age ⩾ 18 years
  • Matched for age/height/weight (+/-5 years; +/- 10 lbs; +/- 10cm) to a scoliosis participant
  • Fluent in English
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Edmonton, Alberta, T6G2G4, Canada

RECRUITING

MeSH Terms

Conditions

Scoliosis

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Eric Parent, PT, PhD, Pr

    University of Alberta

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Parent, PT, PhD, Pr

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2019

First Posted

September 14, 2022

Study Start

May 6, 2019

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations