Shoulder Adhesive CapsulitisNCT04897308
Best Treatment Modality of Frozen Shoulder
A study testing Local injection of shoulder joint in people with Shoulder Adhesive Capsulitis, run by Sohag University at 1 site in Egypt.
Trial summary
This study will compare between the effect of three treatment modalities of shoulder adhesive capsulitis to hilight the best technique to improve pain and range of motion outcome measures . Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Shoulder Adhesive Capsulitis
- What is being tested?
- Local injection of shoulder joint
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 1 Apr 2022
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- gross limitation of passive shoulder movement
- pain interfering with daily activities
- painful restiction of active and passive movement of shoulder
Who cannot join
- presence of degenerative pathology
- fracture
- contraindication to steroid injection
- deformity affecting upper limb
- history of previous shoulder injection in the past 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shoulder Adhesive Capsulitis ; Comparison Between Three Theraputic Approaches
This study will compare between the effect of three treatment modalities of shoulder adhesive capsulitis to hilight the best technique to improve pain and range of motion outcome measures .
- Conditions
- Shoulder Adhesive Capsulitis
- Being tested
- Local injection of shoulder joint
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local injection of shoulder jointProcedure or surgery
Under ultrasound guidance , local shoulder joint injection will be done
| Study group | Role | What they receive |
|---|---|---|
| Suprascapular nerve block | Active comparator | This group will include will under go suprascapularnerve block as following :10 ml of .5% bupivacaine and 2 ml of methylpradnisolon 40mg/ml Receives: Procedure: Local injection of shoulder joint |
| Hydrodilatation of shoulder capsule | Active comparator | This group will undergo intraarticular hydrodilatation by injection of :first lidocaine10ml%followed by 1ml of methylprednisolon 40mg/ml and finally 20ml of .9 % sodium chloride slowly in the gleno humeral joint Receives: Procedure: Local injection of shoulder joint |
| Hydrodilatation of shoulder interval | Active comparator | This group will undergo interval hydrodilatation by injection of :first mepivacaine 10ml folowed by 20ml of sterile water slowly in the shoulder interval Receives: Procedure: Local injection of shoulder joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in range of motion of shoulder joint
Improvement will be measured by measuring active and passive range of motion
Measured: 12 weeks efter intervention
Improvement in pain
Improvement will be measured by VAS ( visual auditory assessment )
Measured: 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start1 May 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Sohag 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shorouk Ayman Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897308
- Sponsor's protocol ID
- Soh-Med-21-05-04
- Status last verified
- Apr 2022
- First submitted
- 16 May 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Adhesive Capsulitis ; Comparison Between Three Theraputic Approaches
- ClinicalTrials.gov ID
- NCT04897308
- Acronym / sponsor ID
- Soh-Med-21-05-04
- Conditions
- Shoulder Adhesive Capsulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 21 May 2021 (actual)
- 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.
This study will compare between the effect of three treatment modalities of shoulder adhesive capsulitis to hilight the best technique to improve pain and range of motion outcome measures .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suprascapular nerve block | Active comparator | Procedure: Local injection of shoulder jointThis group will include will under go suprascapularnerve block as following :10 ml of .5% bupivacaine and 2 ml of methylpradnisolon 40mg/ml |
| Hydrodilatation of shoulder capsule | Active comparator | Procedure: Local injection of shoulder jointThis group will undergo intraarticular hydrodilatation by injection of :first lidocaine10ml%followed by 1ml of methylprednisolon 40mg/ml and finally 20ml of .9 % sodium chloride slowly in the gleno humeral joint |
| Hydrodilatation of shoulder interval | Active comparator | Procedure: Local injection of shoulder jointThis group will undergo interval hydrodilatation by injection of :first mepivacaine 10ml folowed by 20ml of sterile water slowly in the shoulder interval |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- gross limitation of passive shoulder movement
- pain interfering with daily activities
- painful restiction of active and passive movement of shoulder
Key exclusion criteria (5 listed)
- presence of degenerative pathology
- fracture
- contraindication to steroid injection
- deformity affecting upper limb
- history of previous shoulder injection in the past 4 weeks
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 |
|---|---|---|
| Local injection of shoulder jointUnder ultrasound guidance , local shoulder joint injection will be done | Procedure or surgery | Hydrodilatation of shoulder capsule, Hydrodilatation of shoulder interval, Suprascapular nerve block |
Primary outcome
Improvement in range of motion of shoulder joint
Time frame: 12 weeks efter intervention
Improvement will be measured by measuring active and passive range of motion
Improvement in pain
Time frame: 12 weeks after intervention
Improvement will be measured by VAS ( visual auditory assessment )
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 6 Apr 2022.
- Individual participant dataSharing planned: No
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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.
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?
A study testing Local injection of shoulder joint in people with Shoulder Adhesive Capsulitis, run by Sohag University at 1 site in Egypt.
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 6 Apr 2022. 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 Egypt. 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.
What does the primary outcome measure?
Improvement in range of motion of shoulder joint (time frame: 12 weeks efter intervention). The study lists 2 primary outcomes in all. 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 6 Apr 2022.