NCT01526031

Brief Summary

The purpose of this study is to evaluate the effectiveness of combined bee venom acupuncture (BVA) and physiotherapy (PT) on frozen shoulder, and whether if the effect of BVA is dose effective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
Last Updated

February 3, 2012

Status Verified

February 1, 2012

Enrollment Period

6 months

First QC Date

February 1, 2012

Last Update Submit

February 1, 2012

Conditions

Frozen Shoulder

Keywords

frozen shoulderbee venom acupuncture

Outcome Measures

Primary Outcomes (1)

  • the Shoulder Pain and Disability Index (SPADI)

    Changes from baseline in SPADI at 2, 4, 8, 12 weeks

Secondary Outcomes (2)

  • Visual Analogue Scale (VAS) for pain intensity

    Changes from baseline in VAS at 2, 4, 8, 12 weeks

  • passive Range of Motion (pROM)

    Changes from baseline in pROM at 2, 4, 8, 12 weeks

Study Arms (3)

BV1

EXPERIMENTAL

1:10,000 bee venom (BV) acupuncture plus physiotherapy

Procedure: 1:10,000 bee venom (BV) acupunctureProcedure: physiotherapy

BV2

EXPERIMENTAL

1:30,000 bee venom (BV) acupuncture plus physiotherapy

Procedure: 1:30,000 bee venom (BV) acupunctureProcedure: physiotherapy

NS

PLACEBO COMPARATOR

Normal saline injection plus physiotherapy

Procedure: normal saline injectionProcedure: physiotherapy

Interventions

1:10,000 bee venom (BV) acupuncturePROCEDURE

after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11) * 1st visit : SC 0.4ml of 1:10,000 BV at 4 points (0.1ml for each points) * 2nd visit : SC 0.6ml of 1:10,000 BV at 6 points (0.1ml for each points) * 3rd visit : SC 0.8ml of 1:10,000 BV at 8 points (0.1ml for each points) * 4th to 16th visit : SC 1.0ml of 1:10,000 BV at 10 points (0.1ml for each points)

BV1
1:30,000 bee venom (BV) acupuncturePROCEDURE

after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11) * 1st visit : SC 0.4ml of 1:30,000 BV at 4 points (0.1ml for each points) * 2nd visit : SC 0.6ml of 1:30,000 BV at 6 points (0.1ml for each points) * 3rd visit : SC 0.8ml of 1:30,000 BV at 8 points (0.1ml for each points) * 4th to 16th visit : SC 1.0ml of 1:30,000 BV at 10 points (0.1ml for each points)

BV2
normal saline injectionPROCEDURE

after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11) * 1st visit : SC 0.4ml of normal saline at 4 points (0.1ml for each points) * 2nd visit : SC 0.6ml of normal saline at 6 points (0.1ml for each points) * 3rd visit : SC 0.8ml of normal saline at 8 points (0.1ml for each points) * 4th to 16th visit : SC 1.0ml of normal saline at 10 points (0.1ml for each points)

NS
physiotherapyPROCEDURE

Physiotherapy treatment will be provided at each visit after bee venom or saline injection. * transcutaneous electrical nerve stimulation (TENS) for 15 minutes * transcutaneous infrared thermotherapy (TDP) for 15 minutes * manual physical therapy for 15 minutes * simple home exercise program

BV1BV2NS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of frozen shoulder by orthopedist
  • Must have shoulder pain of more than VAS 5 over 1 month and under 12 months
  • Marked limitation of active and/or passive motion range in one shoulder

You may not qualify if:

  • history of major shoulder injury or surgery
  • other musculoskeletal pain
  • cervical neuropathy, paralysis, neurological disorder
  • hypersensitivity reactions by bee venom skin test
  • renal or hepatic disorders, hematologic diseases, cancer, mental disorders, inflammatory or infectious disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthritis & Rheumatism Center, Kyung Hee University Hospital at Gangdong

Seoul, 134-727, South Korea

Location

MeSH Terms

Conditions

Bursitis

Interventions

Bee VenomsAcupuncture TherapySaline SolutionPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthropod VenomsVenomsComplex MixturesToxins, BiologicalBiological FactorsComplementary TherapiesTherapeuticsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsRehabilitation

Study Officials

  • Yonghyeon Baek, OMD, Ph.D

    Kyung Hee University Hospital at Gangdong

    PRINCIPAL INVESTIGATOR

  • Byung-Kwan Seo, OMD, Ph.D

    Kyung Hee University Hospital at Gangdong

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor

Study Record Dates

First Submitted

February 1, 2012

First Posted

February 3, 2012

Study Start

January 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 3, 2012

Record last verified: 2012-02

Locations

KR(1)