The Adult Degenerative Scoliosis Exercise Trial (Pilot Study)
The Adult Degenerative Scoliosis Exercise Trial (Pilot Study)
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.
1.1 Adult degenerative scoliosis. Scoliosis is a 3D spine deformity including frontal curves,
 vertebral rotations, and sagittal changes.1 A curve >10o after 18 years of age is called
 Adult Scoliosis (AS) and is the most common adult spinal deformity.2 Degenerative AS arises
 from asymmetric disc and facet degeneration or due to leg length discrepancy, hip pathology,
 and osteoporosis.3 Most AS curves are lumbar or thoracolumbar.4 The prevalence of
 degenerative AS is higher than adolescent scoliosis, but estimates range widely at 2.4% -
 68%56. The prevalence of curves >20° is 24%.7

 AS causes pain, curve progression, radiculopathy, or cosmetic deformity affecting quality of
 life and physical function8-10. Pain affects 90% of patients with AS9. Adults with
 degenerative scoliosis present more pain than with idiopathic scoliosis.3 Severe
 radiculopathy (47%), claudication (9%), weakness (8%), myelopathy, and bowel/bladder
 dysfunction(1%) are also more common in adults with scoliosis.11 Sagittal imbalance in AS is
 strongly correlated with disability and low quality of life.12 Curve progression is common in
 AS at 2-6o/yr.13 It is thus relevant to offer treatments to prevent curve progression and the
 signs and symptoms above.

 1.2 What treatment is available? There is an important lack of evidence about non-operative
 treatments for AS despite the recommendation of non-operative treatments are the first line
 for treating AS.8,14,15 This suggestion arise mostly because of the high complications rates
 with surgery and poor bone quality8. However, exercise has generally not been offered in
 studies comparing non-operative to operative care.8,14,15 The main goal of rehabilitation in
 AS is to decrease pain, improve function and slow disease progression to avoid surgery.16,17
 Our review on exercises for AS18 found only one study with high risk of bias showing that 20
 weeks of scoliosis specific exercises compared to general physiotherapy led to significantly
 more improved pain (by 3.2/10 pts), SRS-22 quality of life (by 0.7/5 for function, 0.9 pain,
 0.5 self-image, 0.7 mental health and 1.0 for satisfaction with care), and Oswestry
 disability (by 12%). Only adults with idiopathic scoliosis were included in this study19 and
 exercises have not yet been tested in adults with degenerative scoliosis.

 1.3 Rationale for Schroth treatment: Our award winning work with adolescent idiopathic
 scoliosis suggests that pain, self-image and back muscle endurance improvements, as well as,
 reduced curve progression result from short exercise programs.20-22 Schroth is a 3D
 autocorrection exercise aiming to correct posture.23 Schroth exercises are not yet routinely
 used for adults in Edmonton, but surgeons and patients have expressed interest for evidence
 on exercise. Patients routinely seek treatment options for smaller curvatures and inquire
 about less invasive treatments than surgery.

 1.4 Schroth treatment: Posture corrections are achieved with the use of pressure, mirror and
 therapist verbal and tactile feedback.24,25 Schroth exercises aim to improve the ability to
 maintain correct posture through endurance and strength training.22 Schroth exercises include
 de-rotation, side shifting, and stretching to establish vertebral alignment, torsion
 respiratory exercises, and strengthening for postural muscles.26

 2. Specific Aims: To conduct a pilot study for an RCT on the effect of Schroth exercises in
 adults with degenerative scoliosis compared to observation. Specific goals of the pilot are
 to: 2.1) Determine the recruitment and eligibility rate of patients for the RCT; 2.2)
 Demonstrate the feasibility of the assessment and treatment protocol by showing a high
 percent compliance with program attendance and home exercises and low study dropout rate; and
 2.3) Estimate the effect size and variability for all outcomes to determine the sample size
 for the proposed RCT.

 3. Methods and Materials

 3.1 Subjects: Adults over 50 years old with degenerative scoliosis (n=20) with pain (>2/10)
 will be recruited from referrals to Dr. Eric Huang and James Mahood and using community ads.
 Other inclusion criteria are: (1) curves 15°-45°. 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.

 3.2 Procedures: Patients will be invited to participate at the Drs' clinics. Participants
 will be randomized to the observation (control) group or the Schroth exercise treatment group
 using REDCAP. All outcomes will be measured at baseline and at a 3-month follow-up. Longer
 term effects will be assessed 3 months after the exercise program. The primary outcome is
 pain at 3 months controlling for medication use.27 Secondary outcomes include: spine curve
 angles, vertebral rotation, SRS-22 questionnaire (self-image, mental health, function, and
 pain and total scores), posture (Surface Topography), Global Rating of Change (GRC), Oswestry
 Disability index, and muscle endurance (Sorensen test). At baseline, a physical exam will
 ensure participants can exercise safely. The control group will be under observation for 3
 months. The Schroth group will participate in weekly supervised sessions and a daily home
 program for 3 months. After 3 months, controls will undergo the same exercise protocol. This
 will allow examining exercise effects using these patients as their own controls and improve
 willingness for randomization.

 3.3.1 Schroth exercises treatment: During the first 2 weeks, participants will attend 5 1-hr
 long individual sessions to learn Schroth exercises and the home program, and to confirm
 independent adequate performance with a checklist.28 A 30-min. daily home program of 3 to 4
 exercises will be prescribed and progressed by the certified Schroth therapist throughout the
 project using an algorithm26. Compliance will be monitored weekly using a logbook. Patients
 will attend weekly 1-hr long group therapist-led exercise classes for 3 months. Classes
 increase compliance and sense of social support.29,30 At each group class, adequate exercise
 performance will be assessed using the checklist.28 An algorithm guides the prescription of
 exercises intensity and progression from static to dynamic depending on the participant's
 ability.28 Prescription begins with Sitting on a Ball. If performed adequately, a more
 challenging exercise is attempted. If performance is not adequate, an easier exercise is
 attempted. The 3 most challenging exercises performed adequately as per the checklist will be
 prescribed with a detailed handout.28

 3.3.2 Control intervention: Observation without treatment or with previously prescribed pain
 medication is the current standard for adults with degenerative scoliosis not planning
 surgery.

 3.4 Co-interventions, contamination monitoring: Pain medication use will be monitored by a
 single score using the validated Medication Quantification Scale.27 Participants will be
 asked to refrain from using co-interventions. Co-intervention use will be monitored as well
 as any contamination where controls may attempt Schroth treatment.

 3.5 Assessment: Evaluators will be blinded to group allocation and patients reminded not to
 divulge.

 3.5.1 Self-Report Questionnaires: Demographic/History- Socio-demographics, medical history,
 symptoms and modifying factors will be self-reported at baseline only to describe
 participants.

 Numeric Pain Rating and diagram- (Primary outcome). A 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.31 A body pain diagram will categorize the location of symptoms with
 high reliability.32

 The Scoliosis Research Society (SRS-22r) is a 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 with good correlations with SF-36, SF-12, and
 Oswestry scores.34

 The 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.35,36

 Global Rating of Change- A 15-point global rating scale,35,37 will only be used at each
 follow-up. The scale ranges from -7 (very great deal worse) to +7 (very great deal better).

 3.5.2 Physical Exam: A physiotherapist blind to group assignment, will determine curve type28
 and assess the range of motion for lower extremities, leg length (supine) and asymmetry in
 the forward bend test (with scoliometer).38,39 Lumbar and thoracic spinal range-of-motion
 will be recorded using double inclinometers: flexion, extension and side flexions. The
 Sorensen's test will assess back extensor endurance as the time the torso is maintained
 horizontal against gravity.40

 3.5.3 3D ultrasound imaging- Standing 3D Ultrasound scans of the spine will be obtained
 without radiation exposure in a positioning frame. An experienced evaluator will extract
 curve angle, and apical vertebra rotations from de-identified images with high reliability
 and interchangeability with radiographs measurements has been shown.41-44

 3.5.4 Full-torso surface topography (ST) - Four Minolta 910 Laser Scanners and a positioning
 frame will be used to record full-torso ST scans. The operator will acquire scans blind to
 treatment groupings. The operator will position the subjects, mark reference points, and
 scan. ST parameters will be extracted in Matlab by digitizing 15 reference points on
 de-identified scans. The parameters quantifying the external trunk deformity are: cosmetic
 score composed of a weighted average of the shoulder angle, scapula angle and waist
 asymmetry, the trunk twist, and kyphotic and lumbar indices and angles from the sagittal
 view.45,46 We found parameters have adequate discriminative validity and sensitivity to
 change.47 Asymmetry maps will also be monitored.48-50

 3.6. Analyses: Objective 1: Recruitment rates will be calculated as the percent of patients
 enrolled out of all patients invited. Eligibility rate corresponds to the percentage of
 patients meeting the selection criteria out of all patients assessed at clinics. Objective 2:
 Compliance will be calculated as the percentage of visits attended and percent prescribed
 home exercises reported performed. Drop-out rate will be calculated as the percentage of
 enrolled patients not completing the study. Objective 3: Cohen's D effect sizes and sample
 size needed will be estimated for all outcomes51,52 targeting a power of 0.80 with alpha of
 0.05 using the observed change and variability from intention-to-treat analyses. Where
 available MCID will inform sample size estimation.

 4. Significance: Adult degenerative scoliosis is a chronic and often painful condition, with
 a profound effect on patients.3,53 The Schroth exercise method is less invasive than current
 treatments (injections, surgery). Our review suggest that exercises can be effective to limit
 pain, disability and other deficits.18 RCTs on Schroth exercises for AS are needed.
 Clinicians and patients from the scoliosis clinic demand research in this area.
Inclusion Criteria:

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

 Exclusion Criteria:

 -  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.