Clinical trial NCT03359941: Acupuncture Treatment for Vertebral Compression Fracture
Official title: Acupuncture Treatment for Pain Relief and Functional Recovery in Patients With Vertebral Compression Fracture
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Fracture
Compression Fracture
Fractures, Bone
Keywords: Integrative Treatments
Korean Traditional medicine
Lead sponsor: Korean Medicine Hospital of Pusan National University
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 7
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

Eligibility criteria: 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°

Primary outcomes:
measure: Pain intensity on the Visual Analog Scale (VAS)
timeFrame: 6 weeks from the first treatment
Secondary outcomes:
measure: Patient's satisfaction with treatment using the Patient Global Assessment(PGA)
timeFrame: 6 weeks from the first treatment
measure: Back-specific dysfunction using the Oswestry Disability Index (ODI)
timeFrame: baseline, 6 weeks from the first treatment, 12 weeks from the first treatment
measure: Quality of life using the Quality-of-Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)
timeFrame: baseline, 6 weeks from the first treatment, 12 weeks from the first treatment
measure: Physical function using Time Up and Go (TUG)
timeFrame: baseline, 6 weeks from the first treatment
measure: Adverse events related to integrative treatments as a measure of safety
timeFrame: under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
measure: Use of medication for pain control during treatment
timeFrame: under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
measure: Number of patients who received surgery
timeFrame: 12 weeks from the first treatment
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University
state: Kyung Sang South Province
Study officials:
affiliation: Korean Medicine Hospital of Pusan National University
name: Kun Hyung Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: