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Acupuncture Treatment for Vertebral Compression Fracture

NCT ID: NCT03359941

Last Updated: 2017-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2016-12-19

Brief Summary

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Patients with vertebral compression fractures (VCF) may experience pain, limitation of daily activities, and various complications (e.g., insomnia, constipation, urinary infection, depression, diminished quality of life).

Objective:

This study aims to evaluate the effectiveness, safety and feasibility of acupuncture treatments to achieve pain relief and functional recovery in patients with VCF.

Detailed Description

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Patients who have subacute or chronic vertebral compression fracture in one or more thoracic/lumbar vertebral body are eligible. Patients who have willingness to participate and provide written informed consents will be treated to the Pusan National University Korean Medicine Hospital with once to three times per weak for six weeks approximately. (total 12-18 sessions)

Conditions

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Spinal Fracture Compression Fracture Fractures, Bone

Keywords

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Integrative Treatments Korean Traditional medicine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Integrative Treatments

This study's arm is single, so all participants will receive acupuncture treatments.

Group Type EXPERIMENTAL

acupuncture

Intervention Type PROCEDURE

Acupuncture points: Examples of acupuncture points to be used include BL23 (Sinsu, bilateral), BL24(Gihaesu, bilateral), BL25(Daejangsu, bilateral), BL40(Wijung, bilateral), BL60(Gollyun, bilateral), BL65(Sokgol, bilateral), LI11(Gokji, bilateral), LI4(Hapgok, bilateral), ST36(Joksamni, bilateral), GB41(Jogimeup, bilateral), LR3(Taechung, bilateral). Electrical stimulation with alternating frequency of 2-100 Hz will be applied to the selected points (e.g., BL 23-25, bilateral). Treatments will be provided by qualified Korean traditional medicine doctors with more than 2 years of clinical experience.

Interventions

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acupuncture

Acupuncture points: Examples of acupuncture points to be used include BL23 (Sinsu, bilateral), BL24(Gihaesu, bilateral), BL25(Daejangsu, bilateral), BL40(Wijung, bilateral), BL60(Gollyun, bilateral), BL65(Sokgol, bilateral), LI11(Gokji, bilateral), LI4(Hapgok, bilateral), ST36(Joksamni, bilateral), GB41(Jogimeup, bilateral), LR3(Taechung, bilateral). Electrical stimulation with alternating frequency of 2-100 Hz will be applied to the selected points (e.g., BL 23-25, bilateral). Treatments will be provided by qualified Korean traditional medicine doctors with more than 2 years of clinical experience.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Is at least 19 years of age
* Radiographic confirmation of one more subacute or chronic stable vertebral compression fractures (x-ray, computerized tomography, or magnetic resonance imaging)
* Patient-reported pain intensity equal or greater than 4 points on 0 to 10 VAS scale at baseline
* Willingness to participate in the study and provide written informed consent
* Is able to give written consent independently or with a supporter's help

Exclusion Criteria

* Pathological fracture (malignancy, myeloma, metabolic disease, etc.)
* Spine malformation
* Pregnancy, infection, impaired cognitive function
* Hypersensitive reaction to acupuncture treatment
* Need for surgical treatment

1. Neurologic deficit: spinal cord injury, cauda equina syndrome
2. Unstable fracture: three-column collapse, burst fracture, posterior ligament rupture, distraction fracture
3. Scoliotic angle ≥ 12°
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korean Medicine Hospital of Pusan National University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kun Hyung Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Korean Medicine Hospital of Pusan National University

Locations

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National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University

Yangsan, Kyung Sang South Province, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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N2015002

Identifier Type: -

Identifier Source: org_study_id