Scoliosis-specific Exercises for Mild Idiopathic Scoliosis

NCT ID: NCT05138393

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-18
• Study Completion Date: 2037-11-30

Brief Summary

Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. In Sweden, mild scoliosis curves not requiring treatment, but at risk for progression during childhood, are only observed until skeletal maturity without active treatment. If progression occurs and treatment is required, standard treatment consists of bracing 20 hours or more per day. Scoliosis-specific exercises have been reported to be a possible treatment modality in terms of halting progression in mild scoliosis, but the findings are not generally accepted.

Detailed Description

Mild forms of idiopathic scoliosis are usually observed with regular clinical and radiological follow-ups during growth periods. Scoliosis specific exercises have been used as a method aiming to halt progression and ultimately avoid the need of brace treatment. However, many cases of mild idiopathic scoliosis will not progress irrespective of treatment. As of today, there are a number of different methods and approaches to scoliosis specific exercises, but all with the aim to correct scoliosis in the sagittal, frontal and transverse plane.

In a multicenter randomized controlled trial, the investigators seek to compare an active self corrective management of scoliosis specific exercises to observation for patients with mild scoliosis. Skeletally immature patients with mild idiopathic scoliosis will be randomized in an online module through the Swedish spine register (www.swespine.se), to receive either the intervention or observation. Outcome assessors will be blinded for the type of management the patients are having. Compliance will be monitored with a mobile application (Physitrack) where the patients and their families can have direct access to the research personnel and their treatment. Outcome measures include changes in curve severity, quality of life, number of patients requiring brace treatment and clinical outcomes. All patients will be evaluated with clinical follow-ups every six months and both clinical and radiological follow-ups each twelve months until either progression occurs or skeletal maturity is reached. Individuals progressing and requiring brace treatment will be offered standard TLSO or nighttime brace to be worn 20 hours and 8 hours, respectively, per day and will be followed in the same way as other participants. Skeletal maturity is defined as less than 1 cm of growth in six months. All patients will be encouraged to be physically active for 60 minutes per day. When skeletal maturity has occured, patients will have clinical and radiological follow-ups at 2, 5 and 10 years after treatment termination. Based on a hypothesized failure rate of 10% in the scoliosis specific exercise group and 39% in the observation group, with a significance level of 5% and a power of 80% and consideration for dropout of up to 20% and an additional adding of five individuals per group, an estimated number of 45 individuals in each group is required.

For individuals who are not willing to be randomized and participate in the study, observation will be offered and these individuals will serve as an observational group with similar follow-ups and will be asked to answer the same survey as the study groups will do.

Conditions

Idiopathic Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active self-corrective exercises

An active self-correction tailored to the individual type of curve and clinical presentation will be applied with the aim to correct the scoliosis in all three planes. Patients will also be informed and educated in task oriented activities of daily living. Training goals are directed towards postural control, spinal stability, muscular stabilization and endurance in corrective postures. Patients will have outpatient sessions once every two weeks the first 3 months and perform the exercises at home in 30-minutes sessions three times per week. Patients are encouraged to continue with non-specific self-mediated physical activities of moderate intensity at least 60 minutes daily. Compliance will be monitored through a mobile application (Physitrack) where the patients record their sessions and can have contact with the research personnel. A cognitive behavioral therapy approach to reinforce physical activity will be performed every 6 months.

Group Type: EXPERIMENTAL

Active self-corrective exercises

Intervention Type: OTHER

Scoliosis specific exercises with an Active self-corrective approach. Non-specific physical activity 60 minutes per day.

Observation

Patients are encouraged to continue with non-specific self-mediated physical activities of moderate intensity at least 60 minutes daily, for the entirety of the study. A cognitive behavioral therapy approach to reinforce physical activity will be performed every 6 months.

Group Type: ACTIVE_COMPARATOR

Observation

Intervention Type: OTHER

Non-specific physical activity 60 minutes per day.

Interventions

Active self-corrective exercises

Scoliosis specific exercises with an Active self-corrective approach. Non-specific physical activity 60 minutes per day.

Intervention Type: OTHER

Observation

Non-specific physical activity 60 minutes per day.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Cobb 15-24 degrees
• Skeletally immature, Sanders score of 4 or less and Risser < 2.
• No menarche for females
• Aged 9-15 years
• Apex of the primary curve at T7 or caudal

Exclusion Criteria

• Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)
• No previous surgical or brace treatment for scoliosis

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Paul Gerdhem

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elias Diarbakerli, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Linköping university hospital

Linköping, , Sweden

Site Status: RECRUITING

Karolinska university hospital

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Elias Diarbakerli, PT, PhD

Role: CONTACT

elias.diarbakerli@regionstockholm.se

+460851770000

Paul Gerdhem, MD, PhD

Role: CONTACT

paul.gerdhem@uu.se

Facility Contacts

Allan Abbott, PT, PhD

Role: primary

Elias Diarbakerli, PT, PhD

Role: primary

Paul Gerdhem, MD, PhD

Role: backup

Other Identifiers

ED-PG-AA-2021-SSE

Identifier Type: -

Identifier Source: org_study_id