NCT06519201

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

Same day

First QC Date

July 16, 2024

Last Update Submit

July 22, 2024

Conditions

Scoliosis Idiopathic

Keywords

Scoliosisspinal realignment therapy

Outcome Measures

Primary Outcomes (1)

  • Numerical Rating Scale (NRS) score

    Patients selected a number that best reflected their pain intensity, where 0 indicates no pain and 10 represents extreme pain, with higher values indicating greater severity of pain.

    A total of 10 sessions from the start date of treatment (takes approximately 2 months)

Secondary Outcomes (1)

  • Cobb's angle

    A total of 10 sessions from the start date of treatment (takes approximately 2 months)

Study Arms (2)

SRT with SpineCare

EXPERIMENTAL

The Trial Group underwent Spinal realignment therapy with SpineCare

Device: SRT with SpineCare

SRT without SpineCare

ACTIVE COMPARATOR

The Control Group underwent Spinal realignment therapy without SpineCare

Device: SRT without SpineCare

Interventions

SRT with SpineCareDEVICE

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.

SRT with SpineCare
SRT without SpineCareDEVICE

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.

SRT without SpineCare

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • Patients with a Cobb's angle of 15-39º on X-rays who consented to par-ticipate in the trial were included.

You may not qualify if:

  • spine-related surgery in the past six months,
  • diagnosis of osteoporosis,
  • history of other non-surgical treatments,
  • participation in another interventional clinical trial in the past month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rebom Clinic

Seoul, Gangnam, 06099, South Korea

Location

Related Publications (23)

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    PMID: 26413145RESULT

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    PMID: 27844226RESULT

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    PMID: 16759352RESULT

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    PMID: 26274967RESULT

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    PMID: 16765303RESULT

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    PMID: 16930488RESULT

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    PMID: 25780260RESULT

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    PMID: 31206094RESULT

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    PMID: 419172RESULT

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    PMID: 5676680RESULT

  • Hood LB, Chrisman D. Intermittent pelvic traction in the treatment of the ruptured intervertebral disk. Phys Ther. 1968 Jan;48(1):21-30. doi: 10.1093/ptj/48.1.21. No abstract available.

    PMID: 5636246RESULT

  • Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.

    PMID: 11690728RESULT

  • Turk DC, Rudy TE, Sorkin BA. Neglected topics in chronic pain treatment outcome studies: determination of success. Pain. 1993 Apr;53(1):3-16. doi: 10.1016/0304-3959(93)90049-U.

    PMID: 8316386RESULT

  • Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.

    PMID: 21856077RESULT

  • Gstoettner M, Sekyra K, Walochnik N, Winter P, Wachter R, Bach CM. Inter- and intraobserver reliability assessment of the Cobb angle: manual versus digital measurement tools. Eur Spine J. 2007 Oct;16(10):1587-92. doi: 10.1007/s00586-007-0401-3. Epub 2007 Jun 5.

    PMID: 17549526RESULT

  • Park SY, Hwang EH, Cho JH, Kim KW, Ha IH, Kim MR, Nam K, Lee MH, Lee JH, Kim N, Shin BC. Comparative Effectiveness of Chuna Manipulative Therapy for Non-Acute Lower Back Pain: A Multi-Center, Pragmatic, Randomized Controlled Trial. J Clin Med. 2020 Jan 5;9(1):144. doi: 10.3390/jcm9010144.

    PMID: 31948083RESULT

  • Stokes IA, Burwell RG, Dangerfield PH; IBSE. Biomechanical spinal growth modulation and progressive adolescent scoliosis--a test of the 'vicious cycle' pathogenetic hypothesis: summary of an electronic focus group debate of the IBSE. Scoliosis. 2006 Oct 18;1:16. doi: 10.1186/1748-7161-1-16.

    PMID: 17049077RESULT

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    PMID: 26213550RESULT

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    PMID: 28872419RESULT

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    PMID: 21328304RESULT

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. SH Kim

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 25, 2024

Study Start

July 14, 2023

Primary Completion

July 14, 2023

Study Completion

November 20, 2023

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)