At a glance
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Effectiveness and Safety of SpineCare Used in Conjunction With Spinal Realignment Therapy in the Treatment of Idiopathic Scoliosis: An Investigator-initiated, Randomized, Single-blind, Pilot Study
In Brief
A clinical study evaluating SRT with SpineCare and SRT without SpineCare for Scoliosis Idiopathic. Completed, enrolled 10 participants across 1 site.
Detailed Summary
* The goal of this study is to evaluate the safety and effectiveness of traction treatment using SpineCare Device. * Research period: May 1, 2023 - November 30, 2023 (7 months) * Research subjects * Male/female between 19 and 70 years old * Scoliosis patients: Scoliosis patients whose Cobb's angle is less than 15°\~39° * Treatment method: Group that applied traction treatment using SpineCare (traction device) and group that applied traction treatment without using SpineCare (traction device) * Treatment period: Treatment twice a week from the 1st to 3rd week from the start of treatment, treatment once a week from the 4th to 7th week, A total of 10 times (takes approximately 2 months) * Treatment time: approximately 50 minutes
Study Details
Timeline
Interventions
Korean medicine doctors performed the treatment regimens.The TG underwent SRT with SpineCare. Treat-ment was administered for six consecutive weeks, with sessions held twice per week dur-ing the first four weeks and once per week during the final two weeks. No additional treatments (e.g., procedures or surgeries) were allowed during the six-week period. To an-alyze pain according to the number of treatment sessions, a counselor assessed patients using the NRS after each of the ten treatment sessions. To compare the differences in Cobb's angle between the groups, X-rays were performed after the first and tenth treatment sessions. Detailed records of adverse events were maintained before and after each treat-ment session.
Korean medicine doctors performed the treatment regimens. The CG underwent SRT without SpineCare. Treat-ment was administered for six consecutive weeks, with sessions held twice per week dur-ing the first four weeks and once per week during the final two weeks. No additional treatments (e.g., procedures or surgeries) were allowed during the six-week period. To an-alyze pain according to the number of treatment sessions, a counselor assessed patients using the NRS after each of the ten treatment sessions. To compare the differences in Cobb's angle between the groups, X-rays were performed after the first and tenth treatment sessions. Detailed records of adverse events were maintained before and after each treat-ment session.