Scoliosis-specific Exercises for Mild Idiopathic Scoliosis

Idiopathic Scoliosis Clinical Trial

Official title:

PREventing Mild Idiopathic SCOliosis PROgression (PREMISCOPRO): a Randomized Controlled Trial Comparing Scoliosis-specific Exercises to Observation in Mild Idiopathic Scoliosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05138393
• Other study ID #: ED-PG-AA-2021-SSE
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2022
• Est. completion date: November 30, 2037

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: Elias Diarbakerli, PT, PhD
• Phone: +460851770000
• Email: elias.diarbakerli[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 30, 2037
• Est. primary completion date: November 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Intervention

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

Locations

Country	Name	City	State
Sweden	Linköping university hospital	Linköping
Sweden	Karolinska university hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients progressing in curve severity	Increase in curve severity (Cobb angle) of more than 6 degrees on two consecutive full-spine frontal radiographs as compared with baseline	Measured at each radiological (annual) follow-up until skeletal maturity. Skeletal maturity is defined as less than 1 cm body height increase in 6 months
Secondary	Angle of trunk rotation	Angle of trunk rotation in forward bending, assessed according to Adams forward bending test with Bunnell's scoliometer	At each six-month follow-up and at 2, 5, 10 years after skeletal maturity
Secondary	Patient-reported outcome measures	Scoliosis Research Society-22r questionnaire (SRS-22r) ranging from 1 (worst) to 5 (best)	At each six-months follow-up and 2, 5, 10 years after skeletal maturity
Secondary	Patient-reported outcome measures	The child-friendly EQ-5D version (EQ-5D-Y) with values ranging from 1 (best) to 3 (worst)	At each six-month follow-up and 2, 5, 10 years after skeletal maturity
Secondary	Patient-reported outcome measures	Pictorial part of Spinal Appearance Questionnaire (pSAQ) with values ranging from 7 (best) to 35 (worst)	At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Secondary	Patient-reported outcome measures	International Physical Activity Questionnaire-short form (IPAQ-SF) where data will be presented as energy expenditure, Metabolic Equivalent Task (MET) minutes, and proportion of individuals reaching moderate activity level. Moderate activity level is considered if 3 or more days of vigorous activity of at least 20 minutes per day, 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day, or 5 or more days of any combination of walking, moderate-intensity, or vigorous-intensity activities accumulating at least 600 MET-minutes per week	At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Secondary	Brace treatment	Number of patients needing brace treatment. Indication for brace treatment is progression of more than 6 degrees on standing frontal radiograph and a primary curve surpassing 25 degrees.	At each six-months follow-up and 2, 5, 10 years after skeletal maturity