Shoulder PainPhase 4NCT02592629
The Efficacy of Local Anesthetics to Reduce Shoulder Pain Post-Steroid Injections
A Phase 4 study testing lidocaine, ethyl chloride and Kenalog in people with Shoulder Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The specific aim of this prospective study is to determine whether local anesthetics prior to subacromial steroid injections reduce pain and consequently if they are cost-effective in the treatment for shoulder pathology. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- lidocaine, ethyl chloride and Kenalog
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to 20 Jun 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 to 70 years old
- Shoulder pain lasting at least 4 weeks
- Inability to use arm with restriction of movement and loss of full function.
- Able to understand study and provide voluntary, written informed consent
Who cannot join
- Less than 18 or greater than 70 years old
- Contraindications of previous injections and previous shoulder surgery
- Unable to understand consent form (in the opinion of the PI)
- Non-English speaking individuals
- Medication contradictions to lidocaine, corticosteroids
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17019
About this study
The specific aim of this prospective study is to determine whether local anesthetics prior to subacromial steroid injections reduce pain and consequently if they are cost-effective in the treatment for shoulder pathology.
Read the detailed description
Shoulder pain is a common problem that can be estimated to be prevalent in up to 15 percent of the patient population registered to general practices and is second only to back pain in patients seeking treatment for musculoskeletal issues in the primary care setting. As a common source of distress, shoulder pain contributes significantly to health care costs.
Rotator cuff disease due to impingement, tendonitis or bursitis is a frequent cause of shoulder pain and dysfunction. Initial treatment consists of a conservative approach of activity modification, oral nonsteroidal anti-inflammatory drugs (NSAIDs) and supervised physical therapy. However, if the patients' symptoms persist, subacromial injections of a local anesthetic such as lidocaine, and a corticosteroid may be indicated as a sequential treatment option.
The steroid injection itself can be a painful process, so administering a local anesthetic prior to the steroid injection is thought to mitigate pain or reduce possible discomfort during and immediately following the procedure. Though there is evidence advocating for the benefits of combining local anesthetics and corticosteroids for the treatment of subacromial pathologies, it is not conclusive whether local anesthesia significantly enhances the pain relieving effect of steroids. Should local anesthesia not have a significant impact on the patient's pain intensity, then the use of corticosteroids alone could potentially result in reduced costs in care.
- Conditions
- Shoulder Pain
- Being tested
- lidocaine, ethyl chloride, Kenalog
- Keywords
- subacromial injection, rotator cuff disease, steroid injection
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineDrug
Also called xylocaine
used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection
ethyl chlorideDrug
Also called chloroethane
topical spray
KenalogDrug
Also called triamcinolone
used with lidocaine in shoulder injection
| Study group | Role | What they receive |
|---|---|---|
| no topical or subcutaneous anesthetic | Active comparator | Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine Receives: Drug: lidocaine; Drug: Kenalog |
| subcutaneous lidocaine | Active comparator | Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection Receives: Drug: lidocaine; Drug: Kenalog |
| topical ethyl chloride | Active comparator | Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds Receives: Drug: lidocaine; Drug: ethyl chloride; Drug: Kenalog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Assessment
Pain assessed on a visual analog scale from 1 (no pain) to 10 (worst pain imaginable). Pain score at 10 minutes post-injection is subtracted from baseline pre-injection score. Positive numbers to represent increases and negative numbers to represent decreases.
Measured: change from baseline assessment before injection at 10 minutes post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study start1 Feb 2016
- Primary completion20 Jun 2017
- Study completion20 Jun 2017
Why it stopped: Lack of time to enroll due to additional responsibilities of the PI and research coordinator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert A. Gallo, Milton S. Hershey Medical Center
- Investigators
- Robert A Gallo, MD, Principal investigator, The Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592629
- Sponsor's protocol ID
- 2690
- Status last verified
- Sep 2018
- First submitted
- 28 Oct 2015
- Last updated
- 16 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Local Anesthetics to Reduce Shoulder Pain Post-Steroid Injections
- ClinicalTrials.gov ID
- NCT02592629
- Acronym / sponsor ID
- 2690
- Conditions
- Shoulder Pain
- Keywords
- subacromial injection, rotator cuff disease, steroid injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of time to enroll due to additional responsibilities of the PI and research coordinator.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Posted 10 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aim of this prospective study is to determine whether local anesthetics prior to subacromial steroid injections reduce pain and consequently if they are cost-effective in the treatment for shoulder pathology.
Detailed description
Shoulder pain is a common problem that can be estimated to be prevalent in up to 15 percent of the patient population registered to general practices and is second only to back pain in patients seeking treatment for musculoskeletal issues in the primary care setting. As a common source of distress, shoulder pain contributes significantly to health care costs.
Rotator cuff disease due to impingement, tendonitis or bursitis is a frequent cause of shoulder pain and dysfunction. Initial treatment consists of a conservative approach of activity modification, oral nonsteroidal anti-inflammatory drugs (NSAIDs) and supervised physical therapy. However, if the patients' symptoms persist, subacromial injections of a local anesthetic such as lidocaine, and a corticosteroid may be indicated as a sequential treatment option.
The steroid injection itself can be a painful process, so administering a local anesthetic prior to the steroid injection is thought to mitigate pain or reduce possible discomfort during and immediately following the procedure. Though there is evidence advocating for the benefits of combining local anesthetics and corticosteroids for the treatment of subacromial pathologies, it is not conclusive whether local anesthesia significantly enhances the pain relieving effect of steroids. Should local anesthesia not have a significant impact on the patient's pain intensity, then the use of corticosteroids alone could potentially result in reduced costs in care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no topical or subcutaneous anesthetic | Active comparator | Drug: lidocaine, Drug: KenalogInjection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine |
| subcutaneous lidocaine | Active comparator | Drug: lidocaine, Drug: KenalogInjection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection |
| topical ethyl chloride | Active comparator | Drug: lidocaine, Drug: ethyl chloride, Drug: KenalogInjection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18 to 70 years old
- Shoulder pain lasting at least 4 weeks
- Inability to use arm with restriction of movement and loss of full function.
- Able to understand study and provide voluntary, written informed consent
Key exclusion criteria (5 listed)
- Less than 18 or greater than 70 years old
- Contraindications of previous injections and previous shoulder surgery
- Unable to understand consent form (in the opinion of the PI)
- Non-English speaking individuals
- Medication contradictions to lidocaine, corticosteroids
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 |
|---|---|---|
| lidocaineAlso: xylocaineused with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection | Drug | no topical or subcutaneous anesthetic, subcutaneous lidocaine, topical ethyl chloride |
| ethyl chlorideAlso: chloroethanetopical spray | Drug | topical ethyl chloride |
| KenalogAlso: triamcinoloneused with lidocaine in shoulder injection | Drug | no topical or subcutaneous anesthetic, subcutaneous lidocaine, topical ethyl chloride |
Primary outcome
Change in Pain Assessment
Time frame: change from baseline assessment before injection at 10 minutes post injection
Pain assessed on a visual analog scale from 1 (no pain) to 10 (worst pain imaginable). Pain score at 10 minutes post-injection is subtracted from baseline pre-injection score. Positive numbers to represent increases and negative numbers to represent decreases.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Shoulder Pain
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Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
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Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
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Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
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Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
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.
Robert A Gallo, MD principal investigator
The Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lidocaine, ethyl chloride and Kenalog in people with Shoulder Pain, run by Milton S. Hershey Medical Center at 1 site in United States.
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 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: stopped early, as of the sponsor's last update on 16 Oct 2018. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Pain Assessment (time frame: change from baseline assessment before injection at 10 minutes post injection). 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 16 Oct 2018.