Compression Fracture, Fractures, Bone, Spinal Fracture
Conditions
Keywords
Integrative Treatments, Korean Traditional medicine
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)
Interventions
PROCEDUREacupuncture
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.
Sponsors
Korean Medicine Hospital of Pusan National University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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°
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity on the Visual Analog Scale (VAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Back-specific dysfunction using the Oswestry Disability Index (ODI) | 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) | 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) | 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. |
| Patient's satisfaction with treatment using the Patient Global Assessment(PGA) | 6 weeks from the first treatment | Response options include very much satisfied, somewhat satisfied, neutral, somewhat dissatisfied, and very much dissatisfied. |
| Use of medication for pain control during treatment | 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 | 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. |
| Adverse events related to integrative treatments as a measure of safety | 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. |
Countries
South Korea
Outcome results
None listed