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Effectiveness and Safety of SpineCare Used in Conjunction With Spinal Realignment Therapy

NCT06519201 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-07-25

No results posted yet for this study

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

Conditions

  • Scoliosis Idiopathic

Interventions

DEVICE

SRT with SpineCare

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.

DEVICE

SRT without SpineCare

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.

Sponsors & Collaborators

  • REBOM CLINIC

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2023-07-14
Completion
2023-11-20

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06519201 on ClinicalTrials.gov