NCT03359941

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2016

Completed
12 months until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

December 10, 2015

Last Update Submit

November 27, 2017

Conditions

Spinal FractureCompression FractureFractures, Bone

Keywords

Integrative TreatmentsKorean Traditional medicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Patient's satisfaction with treatment using the Patient Global Assessment(PGA)

    6 weeks from the first treatment

  • Back-specific dysfunction using the Oswestry Disability Index (ODI)

    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)

    baseline, 6 weeks from the first treatment, 12 weeks from the first treatment

  • Physical function using Time Up and Go (TUG)

    baseline, 6 weeks from the first treatment

  • 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

  • +2 more secondary outcomes

Study Arms (1)

Integrative Treatments

EXPERIMENTAL

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

Procedure: acupuncture

Interventions

acupuncturePROCEDURE

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.

Integrative Treatments

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pathological fracture (malignancy, myeloma, metabolic disease, etc.)
  • Spine malformation
  • Pregnancy, infection, impaired cognitive function
  • Hypersensitive reaction to acupuncture treatment
  • Need for surgical treatment
  • Neurologic deficit: spinal cord injury, cauda equina syndrome
  • Unstable fracture: three-column collapse, burst fracture, posterior ligament rupture, distraction fracture
  • Scoliotic angle ≥ 12°

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University

Yangsan, Kyung Sang South Province, 626770, South Korea

Location

MeSH Terms

Conditions

Spinal FracturesFractures, CompressionFractures, Bone

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Kun Hyung Kim, PhD

    Korean Medicine Hospital of Pusan National University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2015

First Posted

December 2, 2017

Study Start

February 1, 2016

Primary Completion

December 19, 2016

Study Completion

December 19, 2016

Last Updated

December 2, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)