Shoulder PainPhase 2NCT01733914
Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain
A Phase 2 study testing Acupuncture in people with Shoulder Pain, run by Peking University at 1 site in China.
Trial summary
According to traditional Chinese medical theories, a variety of acupuncture formulas can treat diseases such as pain. For example, stimulating acupoints either local or distal to the pain site has been proposed under some conditions. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Acupuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Aug 2013
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uni-lateral shoulder pain for 6 weeks to 2 years
- VAS score ≤ 50
- 25-65 years of age
- Positive Neer's or Hawkins' signs
- Accept the informed consent
Who cannot join
- Shoulder pain of neurological origins
- Shoulder pain of neck origins
- Systematic arthritis
- Wrist problems
- Previous shoulder, arm, neck or chest fractures or surgeries
- Mental diseases
Show all 12Show fewer
- Pregnancy
- Inability to work for more than 3 months before treatment
- Diabetes
- Coagulative dysfunction
- Corticosterone or physicotherapy experience on the affected shoulder in the last 6 months
- Failure to accept the informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Province Hospital of Integrative Chinese and Western Medicine, Sichuan
Chengdu, Sichuan, 100191
About this study
Official title: Phase II Study of Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain
According to traditional Chinese medical theories, a variety of acupuncture formulas can treat diseases such as pain. For example, stimulating acupoints either local or distal to the pain site has been proposed under some conditions. We hypothesize that stimulating acupoints contralateral to the pain site can successfully treat chronic shoulder pain.
- Conditions
- Shoulder Pain
- Being tested
- Acupuncture, Control
- Keywords
- shoulder pain, acupuncture
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Acupuncture in the following acupoints on the contralateral side of pain site: Jiantong, Zhongzhu, Houxi, and Quchi. The patient will receive 5 treatments (each lasts 30 min) per week for four weeks.
ControlOther
Patients in the waiting list group received conventional orthopaedic therapy including physical exercise, heat or cold therapy. 50 mg diclofenac daily could be taken when the patient suffered from the pain. Injections or cortisone applications of any kind were not allowed.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Experimental group Receives: Procedure: Acupuncture |
| Waiting list | Sham comparator | Control group Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
Pain assessment
Measured: before and 2, 4, 8 and 16 weeks after treatment start
Secondary outcomes (3)
The MOS item short from health survey (SF-36)
Quality of life assessment
Measured: before and 8 and 16 weeks after treatment start
Constant-Murley score
shoulder motion score
Measured: before and 2, 4, 8 and 16 weeks after treatment start
DASH score
Measured: before and 2, 4, 8 and 16 weeks after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startSep 2011
- Primary completionApr 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland
- Responsible party
- Principal investigator, Ming Yi, PhD, principle investigator, Peking University
- Investigators
- Ming Yi, PhD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733914
- Sponsor's protocol ID
- 2007CB512501
- Status last verified
- May 2014
- First submitted
- 21 Nov 2012
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang H, Sun J, Wang C, Yu C, Wang W, Zhang M, Lao L, Yi M, Wan Y. Randomised controlled trial of contralateral manual acupuncture for the relief of chronic shoulder pain. Acupunct Med. 2016 Jun;34(3):164-70. doi: 10.1136/acupmed-2015-010947. Epub 2016 Jan 21.
PubMed 26795764
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain
- ClinicalTrials.gov ID
- NCT01733914
- Acronym / sponsor ID
- 2007CB512501
- Conditions
- Shoulder Pain
- Keywords
- shoulder pain, acupuncture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- University of Maryland
- Study start
- Sep 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 27 Nov 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.
According to traditional Chinese medical theories, a variety of acupuncture formulas can treat diseases such as pain. For example, stimulating acupoints either local or distal to the pain site has been proposed under some conditions. We hypothesize that stimulating acupoints contralateral to the pain site can successfully treat chronic shoulder pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupunctureExperimental group |
| Waiting list | Sham comparator | Other: ControlControl group |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Uni-lateral shoulder pain for 6 weeks to 2 years
- VAS score ≤ 50
- 25-65 years of age
- Positive Neer's or Hawkins' signs
- Accept the informed consent
Key exclusion criteria (12 listed)
- Shoulder pain of neurological origins
- Shoulder pain of neck origins
- Systematic arthritis
- Wrist problems
- Previous shoulder, arm, neck or chest fractures or surgeries
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 |
|---|---|---|
| AcupunctureAcupuncture in the following acupoints on the contralateral side of pain site: Jiantong, Zhongzhu, Houxi, and Quchi. The patient will receive 5 treatments (each lasts 30 min) per week for four weeks. | Procedure or surgery | Acupuncture |
| ControlPatients in the waiting list group received conventional orthopaedic therapy including physical exercise, heat or cold therapy. 50 mg diclofenac daily could be taken when the patient suffered from the pain. Injections or cortisone applications of any kind were not allowed. | Other | Waiting list |
Primary outcome
Visual analogue scale (VAS)
Time frame: before and 2, 4, 8 and 16 weeks after treatment start
Pain assessment
3 secondary outcomes
The MOS item short from health survey (SF-36)
Time frame: before and 8 and 16 weeks after treatment start
Constant-Murley score
Time frame: before and 2, 4, 8 and 16 weeks after treatment start
DASH score
Time frame: before and 2, 4, 8 and 16 weeks after treatment start
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 14 Apr 2015.
- Derived from this study: PubMed 26795764Zhang H, Sun J, Wang C, Yu C, Wang W, Zhang M, Lao L, Yi M, Wan Y. Randomised controlled trial of contralateral manual acupuncture for the relief of chronic shoulder pain. Acupunct Med. 2016 Jun;34(3):164-70. doi: 10.1136/acupmed-2015-010947. Epub 2016 Jan 21.
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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.
Ming Yi, PhD principal investigator
Peking University
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 Acupuncture in people with Shoulder Pain, run by Peking University at 1 site in China.
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 5 inclusion and 12 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 14 Apr 2015. 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 China. 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?
Visual analogue scale (VAS) (time frame: before and 2, 4, 8 and 16 weeks after treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01733914, which also lists 1 linked publication.
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 14 Apr 2015.