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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
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.
National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University
Yangsan, Kyung Sang South Province, South Korea
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).
Time frame: 6 weeks from the first treatment
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.
Time frame: 6 weeks from the first treatment
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.
Time frame: 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)
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
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.
Time frame: baseline, 6 weeks from the first treatment
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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.
Time frame: under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
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.
Time frame: under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
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.
Time frame: 12 weeks from the first treatment