Acupuncture Treatment for Vertebral Compression Fracture
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03359941|
Recruitment Status : Terminated (Low recruit rate)
First Posted : December 2, 2017
Last Update Posted : December 2, 2017
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).
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Integrative Treatments
This study's arm is single, so all participants will receive acupuncture treatments.
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.
- 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).
- 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.
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
|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|
|Principal Investigator:||Kun Hyung Kim, PhD||Korean Medicine Hospital of Pusan National University|