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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

December 10, 2015
December 2, 2017
December 2, 2017
February 1, 2016
December 19, 2016   (Final data collection date for primary outcome measure)
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).
Same as current
No Changes Posted
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
Acupuncture Treatment for Vertebral Compression Fracture
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.

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)
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Spinal Fracture
  • Compression Fracture
  • Fractures, Bone
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.
Experimental: Integrative Treatments
This study's arm is single, so all participants will receive acupuncture treatments.
Intervention: Procedure: acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
Same as current
December 19, 2016
December 19, 2016   (Final data collection date for primary outcome measure)

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°
Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT03359941
N2015002
Yes
Not Provided
Plan to Share IPD: No
Korean Medicine Hospital of Pusan National University
Korean Medicine Hospital of Pusan National University
Not Provided
Principal Investigator: Kun Hyung Kim, PhD Korean Medicine Hospital of Pusan National University
Korean Medicine Hospital of Pusan National University
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP