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Acupuncture Treatment for Vertebral Compression Fracture

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ClinicalTrials.gov Identifier: NCT03359941
Recruitment Status : Terminated (Low recruit rate)
First Posted : December 2, 2017
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Korean Medicine Hospital of Pusan National University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Spinal Fracture Compression Fracture Fractures, Bone Procedure: acupuncture Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture Treatment for Pain Relief and Functional Recovery in Patients With Vertebral Compression Fracture
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : December 19, 2016
Actual Study Completion Date : December 19, 2016

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    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°
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359941


Locations
Korea, Republic of
National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University
Yangsan, Kyung Sang South Province, Korea, Republic of, 626770
Sponsors and Collaborators
Korean Medicine Hospital of Pusan National University
Investigators
Principal Investigator: Kun Hyung Kim, PhD Korean Medicine Hospital of Pusan National University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Korean Medicine Hospital of Pusan National University
ClinicalTrials.gov Identifier: NCT03359941     History of Changes
Other Study ID Numbers: N2015002
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Korean Medicine Hospital of Pusan National University:
Integrative Treatments
Korean Traditional medicine

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Compression
Spinal Fractures
 Wounds and Injuries
Spinal Injuries
Back Injuries