Acupuncture Treatment for Vertebral Compression Fracture

Fractures, Bone Clinical Trial

Official title:

Acupuncture Treatment for Pain Relief and Functional Recovery in Patients With Vertebral Compression Fracture

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03359941
• Other study ID #: N2015002
• Status: Terminated
• Phase: N/A
• First received: December 10, 2015
• Last updated: November 27, 2017
• Start date: February 1, 2016
• Est. completion date: December 19, 2016

Study information

• Verified date: November 2017
• Source: Korean Medicine Hospital of Pusan National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 19, 2016
• Est. primary completion date: December 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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°

Related Conditions & MeSH terms

• Compression Fracture
• Fractures, Bone
• Fractures, Compression
• Spinal Fracture
• Spinal Fractures

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University	Yangsan	Kyung Sang South Province

Sponsors (1)

Lead Sponsor	Collaborator
Korean Medicine Hospital of Pusan National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 weeks from the first treatment
Secondary	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.	6 weeks from the first treatment
Secondary	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.	baseline, 6 weeks from the first treatment, 12 weeks from the first treatment
Secondary	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.	baseline, 6 weeks from the first treatment, 12 weeks from the first treatment
Secondary	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.	baseline, 6 weeks from the first treatment
Secondary	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.	under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
Secondary	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.	under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
Secondary	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.	12 weeks from the first treatment