Shoulder CapsulitisNCT05194852
Ultrasound-guided Anterior Hydrodilatation in Shoulder Adhesive Capsulitis
A study testing ultrasound-guided posterior hydrodilatation, corticosteroid, saline, and local anesthetic and guided stretching and strengthening exercise program in people with Shoulder Capsulitis, run by Tanta University at 1 site in Egypt.
Trial summary
A prospective randomized controlled study among 60 consecutive adhesive capsulitis to compare between the ultrasound-guided anterior hydrodilatation in rotator interval and the posterior approach. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Shoulder Capsulitis
- What is being tested?
- ultrasound-guided posterior hydrodilatation, corticosteroid, saline, and local anesthetic and guided stretching and strengthening exercise program
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2018to 28 Sep 2018
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients aged 35 to 60 years,
- patients who suffered pain and stiffness in only one shoulder, for 1 to 6 months
- patients who had restriction of passive motion.
Who cannot join
- patients with previous trauma,
- patients with neurological
- patients with endocrinal diseases
- patients with shoulder tumor
- patients with arthritis
- people who had received intra-articular shoulder injection within the last 6 months.
- Patients with tendon tear
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Shoulder Adhesive Capsulitis, Ultrasound-guided Anterior Hydrodilatation in Rotator Interval is More Effective Than Posterior Approach: a Randomized Controlled Study
A prospective randomized controlled study among 60 consecutive adhesive capsulitis to compare between the ultrasound-guided anterior hydrodilatation in rotator interval and the posterior approach.
Read the detailed description
patients was randomized into two equal groups. Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach; group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach.
Both groups received guided stretching exercises for 3 months after injection. Baseline and 3 months evaluation of pain by visual analogue scale (VAS), shoulder pain and disability index (SPADI), and range of motion (ROM) had been recorded for all patients.
A statistical power analysis was performed after sample size estimation, based on data from the current study (N = 60), comparing group I to group II.
Qualitative data was expressed as numbers and percentages, and Chi-squared test, Quantitative data were expressed as mean and standard deviation.
- Conditions
- Shoulder Capsulitis
- Being tested
- ultrasound-guided posterior hydrodilatation, corticosteroid, saline, and local anesthetic, guided stretching and strengthening exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided posterior hydrodilatationProcedure or surgery
Group I was treated through posterior approach; The injection needle is introduced at the skin surface just lateral to the transducer and in an oblique lateral to medial direction. Group II was treated through anterior rotator interval approach. A 21-gauge needle is introduced into the rotator interval using an oblique path within the imaging plane of the transducer; from lateral to medial, the needle tip is imaged in real time throughout its passage from superficial to deep and is positioned in the biceps tendon sheath between the coracohumeral ligament above and biceps tendon below. Both groups were given the same guided stretching and strengthening exercise program
corticosteroid, saline, and local anestheticDrug
corticosteroid, saline, and local anesthetic
guided stretching and strengthening exercise programOther
guided stretching and strengthening exercise program
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach Receives: Procedure: ultrasound-guided posterior hydrodilatation; Drug: corticosteroid, saline, and local anesthetic; Other: guided stretching and strengthening exercise program |
| group 2 | Experimental | group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach Receives: Procedure: ultrasound-guided posterior hydrodilatation; Other: guided stretching and strengthening exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analoge state
minimum value: 0 maximum value: 10 higher scores mean a worse outcome.
Measured: 3 months
shoulder pain and disability index
minimum value: 0 maximum value: 100 higher scores mean a worse outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start2 Jan 2018
- Primary completion30 Jun 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder CapsulitisStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Hassan Abu-Zaid, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194852
- Sponsor's protocol ID
- hydro1
- Status last verified
- Jan 2022
- First submitted
- 2 Dec 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Shoulder Adhesive Capsulitis, Ultrasound-guided Anterior Hydrodilatation in Rotator Interval is More Effective Than Posterior Approach: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05194852
- Acronym / sponsor ID
- hydro1
- Conditions
- Shoulder Capsulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 18 Jan 2022 (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.
A prospective randomized controlled study among 60 consecutive adhesive capsulitis to compare between the ultrasound-guided anterior hydrodilatation in rotator interval and the posterior approach.
Detailed description
patients was randomized into two equal groups. Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach; group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach.
Both groups received guided stretching exercises for 3 months after injection. Baseline and 3 months evaluation of pain by visual analogue scale (VAS), shoulder pain and disability index (SPADI), and range of motion (ROM) had been recorded for all patients.
A statistical power analysis was performed after sample size estimation, based on data from the current study (N = 60), comparing group I to group II.
Qualitative data was expressed as numbers and percentages, and Chi-squared test, Quantitative data were expressed as mean and standard deviation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Procedure: ultrasound-guided posterior hydrodilatation, Drug: corticosteroid, saline, and local anesthetic, Other: guided stretching and strengthening exercise programGroup I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach |
| group 2 | Experimental | Procedure: ultrasound-guided posterior hydrodilatation, Other: guided stretching and strengthening exercise programgroup II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients aged 35 to 60 years,
- patients who suffered pain and stiffness in only one shoulder, for 1 to 6 months
- patients who had restriction of passive motion.
Key exclusion criteria (7 listed)
- patients with previous trauma,
- patients with neurological
- patients with endocrinal diseases
- patients with shoulder tumor
- patients with arthritis
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 |
|---|---|---|
| ultrasound-guided posterior hydrodilatationGroup I was treated through posterior approach; The injection needle is introduced at the skin surface just lateral to the transducer and in an oblique lateral to medial direction. Group II was treated through anterior rotator interval approach. A 21-gauge needle is introduced into the rotator interval using an oblique path within the imaging plane of the transducer; from lateral to medial, the needle tip is imaged in real time throughout its passage from superficial to deep and is positioned in the biceps tendon sheath between the coracohumeral ligament above and biceps tendon below. Both groups were given the same guided stretching and strengthening exercise program | Procedure or surgery | group 1, group 2 |
| corticosteroid, saline, and local anestheticcorticosteroid, saline, and local anesthetic | Drug | group 1 |
| guided stretching and strengthening exercise programguided stretching and strengthening exercise program | Other | group 1, group 2 |
Primary outcome
visual analoge state
Time frame: 3 months
minimum value: 0 maximum value: 10 higher scores mean a worse outcome.
shoulder pain and disability index
Time frame: 3 months
minimum value: 0 maximum value: 100 higher scores mean a worse outcome.
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 18 Jan 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Shoulder Capsulitis
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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 ultrasound-guided posterior hydrodilatation, corticosteroid, saline, and local anesthetic and guided stretching and strengthening exercise program in people with Shoulder Capsulitis, run by Tanta 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 7 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 18 Jan 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?
visual analoge state (time frame: 3 months). 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 18 Jan 2022.