Frozen ShoulderNCT00926094
Prevalence of Impaired Glucose Tolerance (IGT) in Patients With Frozen Shoulder
An observational study of Frozen Shoulder and Impairment Glucose Tolerance, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Idiopathic Adhesive Capsulitis, Frozen Shoulder is a condition in which there is a limitation and significant pain at the shoulder and it is increases with shoulder movements. The causes are not clear. The prevalence of this condition is four times higher in diabetic patient compare to the general population. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Frozen Shoulder, Impairment Glucose Tolerance
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2009to Jan 2011
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: people that were diagnosed with frozen shoulder at the last three years and are not diabetic.
Who may be able to join
- age 30-60.
- previous Xray that eliminates other disease of the shoulder.
- previous US that eliminates tendon shoulder rupture
- shoulder movement in all directions, with limitation in the external rotation (at least 50%)
Who cannot join
- Diagnosed Diabetes (pregnancy diabetes includes)
- Taking Hyperglycemic medications (like Steroids)
- Fracture or operation in the shoulder before the diagnosis of frozen shoulder.
Trial locations and contacts
1 site in 1 country.
About this study
Idiopathic Adhesive Capsulitis, Frozen Shoulder is a condition in which there is a limitation and significant pain at the shoulder and it is increases with shoulder movements. The causes are not clear. The prevalence of this condition is four times higher in diabetic patient compare to the general population.
The relation between frozen shoulder and impaired glucose tolerance remain unclear.
Our hypothesis is that patients with no diabetes and that suffer from frozen shoulder have a higher prevalence of impaired glucose tolerance than the general population age matched.
- Conditions
- Frozen Shoulder, Impairment Glucose Tolerance
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2011
- Study completionJan 2011
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.
- More trials run by Hadassah Medical OrganizationThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926094
- Sponsor's protocol ID
- SAF04-HMO-CTIL
- Status last verified
- Apr 2011
- First submitted
- 21 Jun 2009
- Last updated
- 12 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Impaired Glucose Tolerance (IGT) in Patients With Frozen Shoulder
- ClinicalTrials.gov ID
- NCT00926094
- Acronym / sponsor ID
- SAF04-HMO-CTIL
- Conditions
- Frozen Shoulder, Impairment Glucose Tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 23 Jun 2009 (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.
Idiopathic Adhesive Capsulitis, Frozen Shoulder is a condition in which there is a limitation and significant pain at the shoulder and it is increases with shoulder movements. The causes are not clear. The prevalence of this condition is four times higher in diabetic patient compare to the general population.
The relation between frozen shoulder and impaired glucose tolerance remain unclear.
Our hypothesis is that patients with no diabetes and that suffer from frozen shoulder have a higher prevalence of impaired glucose tolerance than the general population age matched.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- people that were diagnosed with frozen shoulder at the last three years and are not diabetic.
Key inclusion criteria (4 listed)
- age 30-60.
- previous Xray that eliminates other disease of the shoulder.
- previous US that eliminates tendon shoulder rupture
- shoulder movement in all directions, with limitation in the external rotation (at least 50%)
Key exclusion criteria (3 listed)
- Diagnosed Diabetes (pregnancy diabetes includes)
- Taking Hyperglycemic medications (like Steroids)
- Fracture or operation in the shoulder before the diagnosis of frozen shoulder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 12 May 2011.
Related trials for Frozen Shoulder
Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
RecruitingPhase 4
Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
Frozen Shoulder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frozen Shoulder and Impairment Glucose Tolerance, run by Hadassah Medical Organization at 1 site in Israel.
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 3 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 12 May 2011. 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 Israel. 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.
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.
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 12 May 2011.