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Acupuncture Treatment for Vertebral Compression Fracture

Primary Purpose

Spinal Fracture, Compression Fracture, Fractures, Bone

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Korean Medicine Hospital of Pusan National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Fracture focused on measuring Integrative Treatments, Korean Traditional medicine

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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°

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Integrative Treatments

Arm Description

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

Outcomes

Primary Outcome Measures

Pain intensity on the Visual Analog Scale (VAS)
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).

Secondary Outcome Measures

Patient's satisfaction with treatment using the Patient Global Assessment(PGA)
Response options include very much satisfied, somewhat satisfied, neutral, somewhat dissatisfied, and very much dissatisfied.
Back-specific dysfunction using the Oswestry Disability Index (ODI)
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.
Quality of life using the Quality-of-Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)
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.
Physical function using Time Up and Go (TUG)
TUG measures the time taken to stand from a chair, walk 3 meters, turn, and return to sitting in the chair.
Adverse events related to integrative treatments as a measure of safety
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.
Use of medication for pain control during 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.
Number of patients who received surgery
The number of patients who participated in the trial but finally received surgery during the study period will be counted.

Full Information

First Posted
December 10, 2015
Last Updated
November 27, 2017
Sponsor
Korean Medicine Hospital of Pusan National University
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1. Study Identification

Unique Protocol Identification Number
NCT03359941
Brief Title
Acupuncture Treatment for Vertebral Compression Fracture
Official Title
Acupuncture Treatment for Pain Relief and Functional Recovery in Patients With Vertebral Compression Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Low recruit rate
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
December 19, 2016 (Actual)
Study Completion Date
December 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korean Medicine Hospital of Pusan National University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Fracture, Compression Fracture, Fractures, Bone
Keywords
Integrative Treatments, Korean Traditional medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrative Treatments
Arm Type
Experimental
Arm Description
This study's arm is single, so all participants will receive acupuncture treatments.
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity on the Visual Analog Scale (VAS)
Description
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).
Time Frame
6 weeks from the first treatment
Secondary Outcome Measure Information:
Title
Patient's satisfaction with treatment using the Patient Global Assessment(PGA)
Description
Response options include very much satisfied, somewhat satisfied, neutral, somewhat dissatisfied, and very much dissatisfied.
Time Frame
6 weeks from the first treatment
Title
Back-specific dysfunction using the Oswestry Disability Index (ODI)
Description
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.
Time Frame
baseline, 6 weeks from the first treatment, 12 weeks from the first treatment
Title
Quality of life using the Quality-of-Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)
Description
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.
Time Frame
baseline, 6 weeks from the first treatment, 12 weeks from the first treatment
Title
Physical function using Time Up and Go (TUG)
Description
TUG measures the time taken to stand from a chair, walk 3 meters, turn, and return to sitting in the chair.
Time Frame
baseline, 6 weeks from the first treatment
Title
Adverse events related to integrative treatments as a measure of safety
Description
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.
Time Frame
under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
Title
Use of medication for pain control during treatment
Description
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.
Time Frame
under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
Title
Number of patients who received surgery
Description
The number of patients who participated in the trial but finally received surgery during the study period will be counted.
Time Frame
12 weeks from the first treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Neurologic deficit: spinal cord injury, cauda equina syndrome Unstable fracture: three-column collapse, burst fracture, posterior ligament rupture, distraction fracture Scoliotic angle ≥ 12°
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun Hyung Kim, PhD
Organizational Affiliation
Korean Medicine Hospital of Pusan National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University
City
Yangsan
State/Province
Kyung Sang South Province
ZIP/Postal Code
626770
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Acupuncture Treatment for Vertebral Compression Fracture

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