Acupuncture Treatment for Vertebral Compression Fracture

November 27, 2017 updated by: Korean Medicine Hospital of Pusan National University

Acupuncture Treatment for Pain Relief and Functional Recovery in Patients With Vertebral Compression Fracture

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Kyung Sang South Province
      • Yangsan, Kyung Sang South Province, Korea, Republic of, 626770
        • National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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°

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrative Treatments
This study's arm is single, so all participants will receive acupuncture treatments.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity on the Visual Analog Scale (VAS)
Time Frame: 6 weeks from the first treatment
VAS will be used to assess pain intensity reflecting average patient-perceived pain during the previous 24 hours. The scale ranges from 0 (no pain) to 10 (the worst pain imaginable).
6 weeks from the first treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's satisfaction with treatment using the Patient Global Assessment(PGA)
Time Frame: 6 weeks from the first treatment
Response options include very much satisfied, somewhat satisfied, neutral, somewhat dissatisfied, and very much dissatisfied.
6 weeks from the first treatment
Back-specific dysfunction using the Oswestry Disability Index (ODI)
Time Frame: baseline, 6 weeks from the first treatment, 12 weeks from the first treatment
The questionnaire has 10 items to assess limitations of various activities of daily living. Each section is scored on a 0-5 score. Total scores are reported from 0 to 100, with higher scores indicating greater disability.
baseline, 6 weeks from the first treatment, 12 weeks from the first treatment
Quality of life using the Quality-of-Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)
Time Frame: baseline, 6 weeks from the first treatment, 12 weeks from the first treatment
QUALEFFO is used to evaluate the effect of back pain and treatment on quality of life. The questionnaire includes 26 items in 5 domains; pain, physical function, social function, general health perception, and mental function. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
baseline, 6 weeks from the first treatment, 12 weeks from the first treatment
Physical function using Time Up and Go (TUG)
Time Frame: baseline, 6 weeks from the first treatment
TUG measures the time taken to stand from a chair, walk 3 meters, turn, and return to sitting in the chair.
baseline, 6 weeks from the first treatment
Adverse events related to integrative treatments as a measure of safety
Time Frame: under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
Expected or unexpected adverse events will be measured during the allocated intervention process and during the entire follow-up period. Both the types of adverse events and their frequency of occurrence will be measured.
under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
Use of medication for pain control during treatment
Time Frame: under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
Information on the use of medication will be collected by directly asking the patient at every visit. Medication type, dose, and frequency will be recorded and assessed.
under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
Number of patients who received surgery
Time Frame: 12 weeks from the first treatment
The number of patients who participated in the trial but finally received surgery during the study period will be counted.
12 weeks from the first treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korean Medicine Hospital of Pusan National University

Investigators

  • Principal Investigator: Kun Hyung Kim, PhD, Korean Medicine Hospital of Pusan National University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

December 19, 2016

Study Completion (Actual)

December 19, 2016

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

November 27, 2017

First Posted (Actual)

December 2, 2017

Study Record Updates

Last Update Posted (Actual)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N2015002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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