Pain, ElbowNCT03262623
Radial Nerve Block for Treatment of Tennis Elbow
A study testing Radial nerve block in people with Pain, Elbow, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
Background: Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that causes pain and functional limitation. Although different nonsurgical conservative therapies such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections in addition to surgical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Elbow
- What is being tested?
- Radial nerve block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Oct 2017to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and above
- presenting with refractory elbow pain
Who cannot join
- patients with:
- osteoarthritis,
- rheumatoid arthritis,
- olecranon bursitis,
- radial nerve entrapment
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Makassed General Hospital
Beirut
Zoher Naja, MD, +9611636000 ext. 6941, zouhnaja@yahoo.com
About this study
Official title: Localized Radial Nerve Block for Treatment of Tennis Elbow: a Prospective, Randomized Clinical Trial
Background: Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that causes pain and functional limitation. Although different nonsurgical conservative therapies such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections in addition to surgical approaches have been used, yet there is no standard treatment for lateral epicondylitis.
Objectives: The primary objective of this study is to assess the effectiveness of nerve stimulator guided radial nerve block for treatment of lateral epicondylitis. The primary outcome measure is pain measured through the Visual Analogue Scale (VAS) at 1 and 2 weeks.
Methods: This is a prospective randomized, double blind clinical trial. Patients will be randomly allocated into two groups. Group I will receive radial nerve block guided by a nerve stimulator. Group II patients will receive placebo through radial nerve block. Patients will be followed up for 2 weeks.
Read the detailed description
Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that causes pain and functional limitation. It is a major arm disorder which occurs commonly in adults between 30 and 50 years, with an estimated prevalence of 1% to 3% in the general population. Lateral epicondylitis results from the overuse of the extensor muscles, causing inflammation or irritation of the tendon insertion. It is common in workers whose job requires manual and repetitive work .
Although different nonsurgical conservative therapies such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections in addition to surgical approaches have been used, yet there is no standard treatment for lateral epicondylitis.
To our knowledge, there are no studies that used nerve-stimulator-guided radial nerve block for the treatment of lateral epicondylitis.
- Conditions
- Pain, Elbow
- Being tested
- Radial nerve block, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial nerve blockOther
A nerve stimulator will be used to localize the radial nerve. Then radial block will be performed. At this point 3-5 ml of the anesthetic mixture is injected. Each 10 ml of the anesthetic mixture contained: 3ml lidocaine 2%, 3ml lidocaine 2% with epinephrine, 1:2000,000, 3ml bupivicaine 0.5% and 1ml clonidine 150 µg/ml.
PlaceboOther
A nerve stimulator will be used to localize the radial nerve. Then radial block will be performed containing normal saline
| Study group | Role | What they receive |
|---|---|---|
| Radial nerve block | Experimental | Patients will receive radial nerve block guided by a nerve stimulator. Receives: Other: Radial nerve block |
| Placebo | Placebo comparator | Patients will receive placebo through radial nerve block Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain will be measured through the Visual Analogue Scale (VAS). The scale ranges between 0 and 10, with 0 being no pain and 10 maximum possible pain
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Oct 2017
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ElbowStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- 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
- NCT03262623
- Sponsor's protocol ID
- 1082017
- Status last verified
- Jan 2022
- First submitted
- 23 Aug 2017
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- 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
- Localized Radial Nerve Block for Treatment of Tennis Elbow: a Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03262623
- Acronym / sponsor ID
- 1082017
- Conditions
- Pain, Elbow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 25 Aug 2017 (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: Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that causes pain and functional limitation. Although different nonsurgical conservative therapies such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections in addition to surgical approaches have been used, yet there is no standard treatment for lateral epicondylitis.
Objectives: The primary objective of this study is to assess the effectiveness of nerve stimulator guided radial nerve block for treatment of lateral epicondylitis. The primary outcome measure is pain measured through the Visual Analogue Scale (VAS) at 1 and 2 weeks.
Methods: This is a prospective randomized, double blind clinical trial. Patients will be randomly allocated into two groups. Group I will receive radial nerve block guided by a nerve stimulator. Group II patients will receive placebo through radial nerve block. Patients will be followed up for 2 weeks.
Detailed description
Lateral epicondylitis, or tennis elbow, is a common musculoskeletal disorder that causes pain and functional limitation. It is a major arm disorder which occurs commonly in adults between 30 and 50 years, with an estimated prevalence of 1% to 3% in the general population. Lateral epicondylitis results from the overuse of the extensor muscles, causing inflammation or irritation of the tendon insertion. It is common in workers whose job requires manual and repetitive work .
Although different nonsurgical conservative therapies such as bracing, physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections in addition to surgical approaches have been used, yet there is no standard treatment for lateral epicondylitis.
To our knowledge, there are no studies that used nerve-stimulator-guided radial nerve block for the treatment of lateral epicondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial nerve block | Experimental | Other: Radial nerve blockPatients will receive radial nerve block guided by a nerve stimulator. |
| Placebo | Placebo comparator | Other: PlaceboPatients will receive placebo through radial nerve 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 above
- presenting with refractory elbow pain
Key exclusion criteria (5 listed)
- osteoarthritis,
- rheumatoid arthritis,
- olecranon bursitis,
- radial nerve entrapment
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 |
|---|---|---|
| Radial nerve blockA nerve stimulator will be used to localize the radial nerve. Then radial block will be performed. At this point 3-5 ml of the anesthetic mixture is injected. Each 10 ml of the anesthetic mixture contained: 3ml lidocaine 2%, 3ml lidocaine 2% with epinephrine, 1:2000,000, 3ml bupivicaine 0.5% and 1ml clonidine 150 µg/ml. | Other | Radial nerve block |
| PlaceboA nerve stimulator will be used to localize the radial nerve. Then radial block will be performed containing normal saline | Other | Placebo |
Primary outcome
Pain score
Time frame: 2 weeks
Pain will be measured through the Visual Analogue Scale (VAS). The scale ranges between 0 and 10, with 0 being no pain and 10 maximum possible 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 Radial nerve block in people with Pain, Elbow, 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 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: 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. Some participants in this study may receive a placebo. 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: 2 weeks). 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.