Shoulder PainPhase 1/2NCT00679887
Chronic Shoulder Pain Treated by Pressures With the Thumbs on the Trigger Points
A Phase 1/2 study testing ischemic compression in people with Shoulder Pain, run by Guy Hains Chiropractor at 1 site in Canada.
Trial summary
The purpose of this study is to find the efficacy of treating the trigger points located around the shoulder in patients suffering from chronic shoulder pain. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- ischemic compression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2003to Dec 2006
- Phase
- Phase 1/2
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 30 to 60 years old.
- To have suffered from shoulder pain on a daly basis for at least 3 months
- Participants had to be able to raise the arm above ther head.
- They had accept to receive 15 chiropractic treatments without charge.
Who cannot join
- Past surgery to the arm.
- Injection to the shoulder in the month preceding the trial.
- A diagnosis of rheumatoid arthritis or any other systemic disorders affecting the joints.
- Shoulder pain from an herniated disc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Shoulder Pain of Myofascial Origin,a Randomised Clinical Trial Using Ischemic Compression Therapy.
The purpose of this study is to find the efficacy of treating the trigger points located around the shoulder in patients suffering from chronic shoulder pain.
Read the detailed description
Chronic shoulder pain is a common condition which should be treated by surgery only wen conservative approaches have been tried. in the present trial the authors intend to find the effectiveness of treating the triggers points located in muscles, ligaments and tendons surrounding the shoulderin patients suffering from chronic shoulder pain.
The technique used in this trial is ischemic compression(thumb tip pressure) on the trigger points
- Conditions
- Shoulder Pain
- Being tested
- ischemic compression
- Keywords
- chiropractic, myofascial trigger points, ischemic compression, shoulder pain
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ischemic compressionProcedure or surgery
Active Comparator, ischemic compression, 3 times a week,5 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Ischemic compression on trigger points located around the shoulder. Active comparator. Ischemic compression, 5 weeks Receives: Procedure: ischemic compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index questionnaire
Measured: At baseline, after 15 treatments ,30 days aftr the treatments and 6 months later
Secondary outcomes (1)
Pain visual analog scale
Measured: After 15 treatments, 30 days after the treatments and 6 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startSep 2003
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy Hains Chiropractor
- Sponsor type
- University, hospital or other
- Investigators
- Guy Hains, DC, Principal investigator, UQTRMartin Descarreaux, DC, PHD, Study chair, UQTR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679887
- Sponsor's protocol ID
- CER-05-102-07.05
- Status last verified
- May 2008
- First submitted
- 15 May 2008
- Last updated
- 19 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Shoulder Pain of Myofascial Origin,a Randomised Clinical Trial Using Ischemic Compression Therapy.
- ClinicalTrials.gov ID
- NCT00679887
- Acronym / sponsor ID
- CER-05-102-07.05
- Conditions
- Shoulder Pain
- Keywords
- chiropractic, myofascial trigger points, ischemic compression, shoulder pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Guy Hains ChiropractorUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 19 May 2008 (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 find the efficacy of treating the trigger points located around the shoulder in patients suffering from chronic shoulder pain.
Detailed description
Chronic shoulder pain is a common condition which should be treated by surgery only wen conservative approaches have been tried. in the present trial the authors intend to find the effectiveness of treating the triggers points located in muscles, ligaments and tendons surrounding the shoulderin patients suffering from chronic shoulder pain.
The technique used in this trial is ischemic compression(thumb tip pressure) on the trigger points
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: ischemic compressionIschemic compression on trigger points located around the shoulder. Active comparator. Ischemic compression, 5 weeks |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 30 to 60 years old.
- To have suffered from shoulder pain on a daly basis for at least 3 months
- Participants had to be able to raise the arm above ther head.
- They had accept to receive 15 chiropractic treatments without charge.
Key exclusion criteria (4 listed)
- Past surgery to the arm.
- Injection to the shoulder in the month preceding the trial.
- A diagnosis of rheumatoid arthritis or any other systemic disorders affecting the joints.
- Shoulder pain from an herniated disc.
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 |
|---|---|---|
| ischemic compressionActive Comparator, ischemic compression, 3 times a week,5 weeks | Procedure or surgery | A |
Primary outcome
Shoulder Pain and Disability Index questionnaire
Time frame: At baseline, after 15 treatments ,30 days aftr the treatments and 6 months later
1 secondary outcome
Pain visual analog scale
Time frame: After 15 treatments, 30 days after the treatments and 6 months later.
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 19 May 2008.
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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.
Guy Hains, DC principal investigator
UQTR
Martin Descarreaux, DC, PHD study chair
UQTR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ischemic compression in people with Shoulder Pain, run by Guy Hains Chiropractor at 1 site in Canada.
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 4 inclusion and 4 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 19 May 2008. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Shoulder Pain and Disability Index questionnaire (time frame: At baseline, after 15 treatments ,30 days aftr the treatments and 6 months later). 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 19 May 2008.