Frozen ShoulderPhase 2NCT01526031
Bee Venom Acupuncture for the Treatment of Frozen Shoulder
A Phase 2 study testing 1:10,000 bee venom (BV) acupuncture, 1:30,000 bee venom (BV) acupuncture and normal saline injection in people with Frozen Shoulder, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- 1:10,000 bee venom (BV) acupuncture, 1:30,000 bee venom (BV) acupuncture and normal saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Jul 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Arthritis & Rheumatism Center, Kyung Hee University Hospital at Gangdong
Seoul, 134-727
About this study
Official title: Randomized Controlled Double Blind Study of Bee Venom Therapy on Adhesive Capsulitis of the Shoulder
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.
- Conditions
- Frozen Shoulder
- Being tested
- 1:10,000 bee venom (BV) acupuncture, 1:30,000 bee venom (BV) acupuncture, normal saline injection, physiotherapy
- Keywords
- frozen shoulder, bee venom acupuncture
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1:10,000 bee venom (BV) acupunctureProcedure or surgery
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)
1:30,000 bee venom (BV) acupunctureProcedure or surgery
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)
normal saline injectionProcedure or surgery
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)
physiotherapyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| BV1 | Experimental | 1:10,000 bee venom (BV) acupuncture plus physiotherapy Receives: Procedure: 1:10,000 bee venom (BV) acupuncture; Procedure: physiotherapy |
| BV2 | Experimental | 1:30,000 bee venom (BV) acupuncture plus physiotherapy Receives: Procedure: 1:30,000 bee venom (BV) acupuncture; Procedure: physiotherapy |
| NS | Placebo comparator | Normal saline injection plus physiotherapy Receives: Procedure: normal saline injection; Procedure: physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Shoulder Pain and Disability Index (SPADI)
Measured: Changes from baseline in SPADI at 2, 4, 8, 12 weeks
Secondary outcomes (2)
Visual Analogue Scale (VAS) for pain intensity
Measured: Changes from baseline in VAS at 2, 4, 8, 12 weeks
passive Range of Motion (pROM)
The 4 motions (abduction, forward flexion, extension, and external rotation) will be checked.
Measured: Changes from baseline in pROM at 2, 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kyung Hee University Hospital at Gangdong
- Responsible party
- Principal investigator, Yonghyeon Baek, Kyunghee University Medical Center
- Investigators
- Yonghyeon Baek, OMD, Ph.D, Principal investigator, Kyung Hee University Hospital at GangdongByung-Kwan Seo, OMD, Ph.D, Study director, Kyung Hee University Hospital at Gangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526031
- Sponsor's protocol ID
- KHNMC-OH-IRB 2009-013
- Status last verified
- Feb 2012
- First submitted
- 1 Feb 2012
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Double Blind Study of Bee Venom Therapy on Adhesive Capsulitis of the Shoulder
- ClinicalTrials.gov ID
- NCT01526031
- Acronym / sponsor ID
- KHNMC-OH-IRB 2009-013
- Conditions
- Frozen Shoulder
- Keywords
- frozen shoulder, bee venom acupuncture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- Kyung Hee University Hospital at Gangdong
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 3 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BV1 | Experimental | Procedure: 1:10,000 bee venom (BV) acupuncture, Procedure: physiotherapy1:10,000 bee venom (BV) acupuncture plus physiotherapy |
| BV2 | Experimental | Procedure: 1:30,000 bee venom (BV) acupuncture, Procedure: physiotherapy1:30,000 bee venom (BV) acupuncture plus physiotherapy |
| NS | Placebo comparator | Procedure: normal saline injection, Procedure: physiotherapyNormal saline injection plus physiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1:10,000 bee venom (BV) acupunctureafter 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) | Procedure or surgery | BV1 |
| 1:30,000 bee venom (BV) acupunctureafter 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) | Procedure or surgery | BV2 |
| normal saline injectionafter 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) | Procedure or surgery | NS |
| physiotherapyPhysiotherapy 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 | Procedure or surgery | BV1, BV2, NS |
Primary outcome
the Shoulder Pain and Disability Index (SPADI)
Time frame: Changes from baseline in SPADI at 2, 4, 8, 12 weeks
2 secondary outcomes
Visual Analogue Scale (VAS) for pain intensity
Time frame: Changes from baseline in VAS at 2, 4, 8, 12 weeks
passive Range of Motion (pROM)
Time frame: Changes from baseline in pROM at 2, 4, 8, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yonghyeon Baek, OMD, Ph.D principal investigator
Kyung Hee University Hospital at Gangdong
Byung-Kwan Seo, OMD, Ph.D study director
Kyung Hee University Hospital at Gangdong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1:10,000 bee venom (BV) acupuncture, 1:30,000 bee venom (BV) acupuncture and normal saline injection in people with Frozen Shoulder, run by Kyunghee University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Shoulder Pain and Disability Index (SPADI) (time frame: Changes from baseline in SPADI at 2, 4, 8, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2012.