An interventional study of acupuncture in Spinal Fracture, Compression Fracture and Fractures, Bone, sponsored by Korean Medicine Hospital of Pusan National University. Terminated at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-12-02.
Sponsored by Korean Medicine Hospital of Pusan National University · Not applicable, Interventional, and Treatment
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)
144 studies on the registry are indexed under Spinal Fractures; 24 are open to participants now.
This study's enrollment of 7 is below the median of 85 across 85 interventional studies indexed under Spinal Fractures.
Browse Spinal Fractures studies →Korean Medicine Hospital of Pusan National University is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Need for surgical treatment
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2016 to primary completion in Dec 2016, 10 months.
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This study is terminated, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Korean Medicine Hospital of Pusan National University