The Adult Degenerative Scoliosis Exercise Trial (Pilot Study)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Alberta

About this trial

Adult degenerative scoliosis is the most common spine deformity in adults. Patients present a lateral curvature of the spine and vertebra rotation. Curves meeting indications for treatment affect 24% of the aging adult population. Adult scoliosis causes pain, curve progression, and cosmetic deformity affecting quality of life and function. Pain affects 90% of patients with AS. Other than surgery for severe cases and pain medication, very little non-operative treatments have been investigated. Scoliosis-specific exercises have shown promise in a single study in adults and in an Alberta adolescent study.

The goal of this pilot randomized controlled trial on the effect of Schroth exercises in adults with degenerative scoliosis compared to observation is to determine the feasibility of conducting a larger study. This study will help plan and secure funding for a larger study by examining the ability to recruit enough eligible participants, whether patients can follow the prescribed program session attendance and complete the home exercises prescribed. The early estimate the effects of the exercises on pain, quality of life, disability, deformity and posture measurements will help determine the potential of this approach and the likely success of a larger RCT. This study addresses a need of adults with degenerative scoliosis who do not meet surgical indications but still experience pain and disability by exploring a promising exercise approach.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults over 50 years old with degenerative scoliosis (n=20) with pain (>2/10). Other inclusion criteria are: (1) curves 15°-45°.

Disqualifiers

Curves over 50° are surgical candidates, and will be excluded. Patients who have had cortisone or anesthetic injections within the last 3 months, surgery or presenting contra-indications to exercises (fractures, cancer, severe cardio-vascular co-morbidities, or osteopenia) will be excluded.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Schroth exercises

    Other intervention

    An exercise program begun individually and then continued in groups.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Schroth exercise groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recruitment rate

Percent of patients enrolled out of all patients invited.

Time frame
1 year

Secondary outcomes

1

Eligibility rate

Percentage of patients meeting the selection criteria out of all patients assessed at clinics.

Time frame
1 year
2

Compliance

Percentage of exercise visits attended

Time frame
1 year
3

Adherence

Percent prescribed home exercises reported performed

Time frame
1 year
4

Drop out rate

Percentage of enrolled patients not completing the study.

Time frame
1 year

Other outcomes

1

Pain intensity assessed bhy the

A numeric pain rating scale from 0 to 10 (worst imaginable pain) will assess current, best, worst pain intensity in the last 24 hours, with documented reliability and validity.

Time frame
3 months, 6 months in Schroth group, 3 months, 6 months, 9 months in Control group
2

Pain location

A body pain diagram will categorize the location of symptoms with high reliability

Time frame
3 months, 6 months in Schroth group, 3 months, 6 months, 9 months in Control group
3

Scoliosis Research Society 22r scores

Quality of life questionnaire with 22 questions assessing 5 domains: function, pain, self-image, mental health (5 questions each), and satisfaction (2 questions).33 Scores correspond to the average of the items. The SRS-22 has adequate test-retest reliability, and validity

Time frame
3 months, 6 months in Schroth group, 3 months, 6 months, 9 months in Control group
4

Oswestry disability questionnaire

assesses back related disability (/100 important disability) using 10 questions. The Oswestry is recommended in the core set in spinal research and presents adequate reliability, validity and responsiveness.

Time frame
3 months, 6 months in Schroth group, 3 months, 6 months, 9 months in Control group

Sponsors and contacts

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