Acupuncture Treatment for Vertebral Compression Fracture

Korean Medicine Hospital of Pusan National University

Status: Terminated

Conditions: Compression Fracture; Spinal Fracture; Fractures, Bone

Treatments: Procedure: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03359941

N2015002

Details and patient eligibility

About

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.

Full 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)

Enrollment: 7 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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°

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Integrative Treatments

Experimental group

Description:

This study's arm is single, so all participants will receive acupuncture treatments.

Treatment:

Procedure: acupuncture