Pain, ShoulderNCT04709874
Paravertebral Block vs. Suprascapular Block for Treatment of Frozen Shoulder
A study testing Paravertebral block and Suprascapular block in people with Pain, Shoulder, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
Background: Adhesive capsulitis, or frozen shoulder, is a major orthopedic condition that causes pain and functional limitation. Although different nonsurgical conservative therapies such as physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections have been used, yet there is no standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Shoulder
- What is being tested?
- Paravertebral block and Suprascapular block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteLebanon
- Study dates
- 2 Jan 2022to Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- presenting with frozen shoulder and were unresponsive to conservative therapy
Who cannot join
- Complete rotator cuff tear
- Osteoarthritis
- Calcified tendinitis
- History of shoulder joint injury
- Cervical radiculopathy
- Bleeding disorder
Show all 9Show fewer
- Active infection
- Allergy to Bupivacaine
- Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Makassed General Hospital
Beirut
Zoher Naja, MD, +9611636000 ext. 6405, zouhnaja@yahoo.com
About this study
Official title: Paravertebral Block Versus Suprascapular Block for Treatment of Frozen Shoulder: a Prospective, Randomized Clinical Trial
Background: Adhesive capsulitis, or frozen shoulder, is a major orthopedic condition that causes pain and functional limitation. Although different nonsurgical conservative therapies such as physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections have been used, yet there is no standard treatment for frozen shoulder.
Objectives: The primary objective of this study is to compare the effectiveness of nerve stimulator guided paravertebral block versus suprascapular block for treatment of frozen shoulder. The primary outcome is pain measured through the Visual Analogue Scale (VAS) over a follow up period of 6 months.
Methods: This is a prospective randomized clinical trial that will be conducted between February 2021 and January 2022. Patients will be randomly allocated into two groups. Group I will receive paravertebral block guided by a nerve stimulator. Group II patients will receive suprascapular nerve block. Patients will be followed up at week 1, month 1, month 3 and month 6.
- Conditions
- Pain, Shoulder
- Being tested
- Paravertebral block, Suprascapular block
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral blockOther
Paravertebral block using nerve stimulator guidance will be done at C7-T1
Suprascapular blockOther
Paravertebral block using nerve stimulator guidance will be done
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral block | Experimental | Patients will receive paravertebral block guided by a nerve stimulator. Receives: Other: Paravertebral block |
| Suprascapular block | Active comparator | Patients will receive suprascapular block Receives: Other: Suprascapular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain will measured through the Visual Analogue Scale (VAS). 0 indicates no pain and 10 indicates maximum pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start2 Jan 2022
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ShoulderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoher Naja, Makassed General Hospital
- Investigators
- Zoher Naja, MD, Principal investigator, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709874
- Sponsor's protocol ID
- 11012021
- Status last verified
- Jan 2022
- First submitted
- 12 Jan 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Paravertebral Block Versus Suprascapular Block for Treatment of Frozen Shoulder: a Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04709874
- Acronym / sponsor ID
- 11012021
- Conditions
- Pain, Shoulder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 14 Jan 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.
Background: Adhesive capsulitis, or frozen shoulder, is a major orthopedic condition that causes pain and functional limitation. Although different nonsurgical conservative therapies such as physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections have been used, yet there is no standard treatment for frozen shoulder.
Objectives: The primary objective of this study is to compare the effectiveness of nerve stimulator guided paravertebral block versus suprascapular block for treatment of frozen shoulder. The primary outcome is pain measured through the Visual Analogue Scale (VAS) over a follow up period of 6 months.
Methods: This is a prospective randomized clinical trial that will be conducted between February 2021 and January 2022. Patients will be randomly allocated into two groups. Group I will receive paravertebral block guided by a nerve stimulator. Group II patients will receive suprascapular nerve block. Patients will be followed up at week 1, month 1, month 3 and month 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paravertebral block | Experimental | Other: Paravertebral blockPatients will receive paravertebral block guided by a nerve stimulator. |
| Suprascapular block | Active comparator | Other: Suprascapular blockPatients will receive suprascapular block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and older
- presenting with frozen shoulder and were unresponsive to conservative therapy
Key exclusion criteria (9 listed)
- Complete rotator cuff tear
- Osteoarthritis
- Calcified tendinitis
- History of shoulder joint injury
- Cervical radiculopathy
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 |
|---|---|---|
| Paravertebral blockParavertebral block using nerve stimulator guidance will be done at C7-T1 | Other | Paravertebral block |
| Suprascapular blockParavertebral block using nerve stimulator guidance will be done | Other | Suprascapular block |
Primary outcome
Pain score
Time frame: 6 months
Pain will measured through the Visual Analogue Scale (VAS). 0 indicates no pain and 10 indicates maximum pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
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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.
Zoher Naja, MD principal investigator
Makassed General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paravertebral block and Suprascapular block in people with Pain, Shoulder, run by Makassed General Hospital at 1 site in Lebanon.
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 2 inclusion and 9 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: status not confirmed, 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 Lebanon. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zoher Naja, MD (+9611636000 ext. 6405, zouhnaja@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 6 months). 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.