Shoulder PainPhase 2NCT00597766
Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain
A Phase 2 study testing Lidocaine and Triamcinolone + Lidocaine in people with Shoulder Pain, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
This is a double-blinded study of subacromial corticosteroid injection (steroid injection to the shoulder) to treat shoulder pain in the paralyzed (hemiplegic) shoulder of chronic stroke survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Lidocaine and Triamcinolone + Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Feb 2012
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18
- upper extremity hemiplegia due to hemorrhagic or nonhemorrhagic stroke
- ≤ 4/5 on manual muscle testing for the deltoid on the affected side if isolated movement is present
- post-stroke duration ≥ 1-mo, but < 24-mo
- shoulder pain sustained for ≥ 1-mo
- BPI 12 ≥ 4 (pain scale)
- willing and able to report pain and other conditions throughout the 4-mo study period
- positive Neer's test
Who cannot join
- evidence of joint or overlying skin infection
- > 2 opioid and/or nonopioid analgesic for shoulder pain (i.e., > 2 regardless of class)
- regular intake of pain medications for any other chronic pain
- steroid injections to the shoulder in the last 6-wks
- history of pre-stroke shoulder pain
- bleeding disorder
Show all 14Show fewer
- for those on Coumadin, INR > 3.0
- history of allergies to lidocaine
- renal insufficiency (Creat > 2.0)
- both history of liver disease \& abnormal liver enzyme lab results
- poorly controlled diabetes (HbA1c > 7.0)
- medical instability
- cognitive deficits; In order to pass the cognitive exam, the participant must exhibit 3/3 registration and recall the same three objects in 30 minutes. The participant must also be able to correctly rank the following three levels of pain from highest to lowest: 1) falling from a 2-story building and breaking both ankles, 2) stubbing one's toe and 3) getting bitten by a mosquito.
- immunocompromised
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trials in Stroke Rehabilitation
This is a double-blinded study of subacromial corticosteroid injection (steroid injection to the shoulder) to treat shoulder pain in the paralyzed (hemiplegic) shoulder of chronic stroke survivors. This study is designed to evaluate pain relief of a standard steroid injection treatment, compared to a high dose treatment and a low dose treatment, for shoulder pain in stroke survivors. A total of 105 chronic stroke survivors with moderate to severe shoulder pain will be enrolled. All eligible participants will undergo an initial test injection to localize pain to the subacromial space. If this turns out to be positive, the subjects will be randomly assigned to one of three groups:
- low dose group which receives 20mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder;
- standard dose group which receives a standard 40mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder; or
- high dose group which receives 60mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder.
Read more
Study participants will all rate their pain in interviews (Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times) and in laboratory-based measures that will be administered at baseline, weeks 4, 8, 12 (4 times). Subjects will be followed for a total of 13 weeks.
The study will thus characterize the dose response of triamcinolone for the treatment of hemiplegic shoulder pain.
Read the detailed description
- A total of 105 chronic stroke survivors with moderate to severe shoulder pain will be enrolled. Subjects will be enrolled in the study for 13 weeks. Subjects who complete the protocol will visit MetroHealth five times.
- Visit 1: Baseline information about demographics, past medical history, and inclusion/exclusion issues will be collected for study participants. Pertinent lab work will be performed to determine initial eligibility.
- Visit 2: All initially eligible participants also will undergo a test injection of lidocaine to localize the pain to the subacromial bursa (Neer's Test). A positive Neer's test is required to finalize eligibility for further participation. Participants who satisfy inclusion/exclusion criteria (including a positive Neer's test) will be randomized to high dose steroid, standard dose steroid, or low dose steroid via a computer generated random number table. The study participants and the observer will be blinded as to these groupings.
- After the initial Neer's test and randomization, participants will receive their assigned injection the same day. Participants then will be followed for an additional 12 weeks, including three follow-up visits (Visits 3-5). The total participation time in this study will be 13 weeks.
- The primary outcome measure will be the BPI 12. The BPI is a pain questionnaire, which assesses the "worst pain" in the previous 7 days. Secondary outcome measures also will be assessed together with BPI 12. There will be 3 additional secondary outcome measures, Fugl-Meyer Motor Assessment (a measure of poststroke motor impairment), pain free external rotation range of motion (ROM) and pain free abduction ROM.
- A blinded therapist will administer all outcome measures. The primary outcome will be assessed on a weekly basis via telephone (or in person during weeks of MetroHealth visits) starting on the day of Visit 1 and continuing to 12-weeks after steroid injection (i.e., for the 13 weeks of the subject's participation). The remaining secondary outcomes will be assessed in clinic visits at least every 4 weeks starting with Visit 2 (Visits 2-5).
- Conditions
- Shoulder Pain
- Being tested
- Lidocaine, Triamcinolone + Lidocaine
- Keywords
- CVA, Hemiplegia, Hemiplegic shoulder pain, Subacromial steroid injection
- Medical subject headings
- Shoulder Pain, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
One-time Screening/Eligibility Neer's Test: 5 cc of 2% lidocaine
Triamcinolone + LidocaineDrug
Also called Kenalog = Triamcinolone
Low Dose -- One-time injection of 20 mg triamcinolone: 1.5 cc of normal saline, 0.5 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine
Triamcinolone + LidocaineDrug
Also called Kenalog = Triamcinolone
Standard Dose -- One-time injection of 40 mg triamcinolone: 1 cc of normal saline, 1 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine
Triamcinolone + LidocaineDrug
Also called Kenalog = Triamcinolone
High Dose -- One-time injection of 60 mg triamcinolone: 0.5 cc of normal saline, 1.5 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Active comparator | Drug: Lidocaine (Neer's Test)
Drug: 20 mg Triamcinolone + Lidocaine Receives: Drug: Lidocaine; Drug: Triamcinolone + Lidocaine |
| Standard Dose | Active comparator | Drug: Lidocaine (Neer's Test)
Drug: 40 mg Triamcinolone + Lidocaine Receives: Drug: Lidocaine; Drug: Triamcinolone + Lidocaine |
| High Dose | Experimental | Drug: Lidocaine (Neer's Test)
Drug: 60 mg Triamcinolone + Lidocaine Receives: Drug: Lidocaine; Drug: Triamcinolone + Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire
Change in BPI-12, Worst pain in the last week on 0 (No Pain) to 10 (Worst Pain Possible) scale, from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.
Measured: Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times)
Secondary outcomes (3)
Fugl-Meyer Motor Assessment, Upper Limb Domain
Evaluates and measures recovery in post-stroke hemiplegic patients. Items are scored on a 3-point ordinal scale:
0 = cannot perform
- = performs partially
- = performs fully Scores for 33 motor function items are summed to arrive at a total score ranging from 0 to 66, where higher scores indicate greater motor function Differences baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.
Measured: Baseline, weeks 4, 8, 12 (4 times)
Pain Free External Rotation Range of Motion (ROM)
Differences in least-mean squares (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.
Measured: Baseline, weeks 4, 8, 12 (4 times)
Pain Free Abduction Range of Motion (ROM)
Difference in least-squares means (Degrees) from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.
Measured: Baseline, weeks 4, 8, 12 (4 times)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionFeb 2012
- Study completionFeb 2012
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Case Western Reserve University
- Responsible party
- Principal investigator, John Chae, MD, MetroHealth Medical Center
- Investigators
- John Chae, MD, Principal investigator, MetroHealth Medical Center; Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597766
- Sponsor's protocol ID
- K24HD054600
- Other IDs
- K24HD054600
- Status last verified
- Nov 2017
- First submitted
- 9 Jan 2008
- Last updated
- 13 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trials in Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT00597766
- Acronym / sponsor ID
- K24HD054600
- Conditions
- Shoulder Pain
- Keywords
- CVA, Hemiplegia, Hemiplegic shoulder pain, Subacromial steroid injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Case Western Reserve University
- Study start
- Dec 2007
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 18 Jan 2008 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blinded study of subacromial corticosteroid injection (steroid injection to the shoulder) to treat shoulder pain in the paralyzed (hemiplegic) shoulder of chronic stroke survivors. This study is designed to evaluate pain relief of a standard steroid injection treatment, compared to a high dose treatment and a low dose treatment, for shoulder pain in stroke survivors. A total of 105 chronic stroke survivors with moderate to severe shoulder pain will be enrolled. All eligible participants will undergo an initial test injection to localize pain to the subacromial space. If this turns out to be positive, the subjects will be randomly assigned to one of three groups:
- low dose group which receives 20mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder;
- standard dose group which receives a standard 40mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder; or
- high dose group which receives 60mg of steroid (triamcinolone) injection to the subacromial space of the affected shoulder.
Study participants will all rate their pain in interviews (Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times) and in laboratory-based measures that will be administered at baseline, weeks 4, 8, 12 (4 times). Subjects will be followed for a total of 13 weeks.
The study will thus characterize the dose response of triamcinolone for the treatment of hemiplegic shoulder pain.
Detailed description
- A total of 105 chronic stroke survivors with moderate to severe shoulder pain will be enrolled. Subjects will be enrolled in the study for 13 weeks. Subjects who complete the protocol will visit MetroHealth five times.
- Visit 1: Baseline information about demographics, past medical history, and inclusion/exclusion issues will be collected for study participants. Pertinent lab work will be performed to determine initial eligibility.
- Visit 2: All initially eligible participants also will undergo a test injection of lidocaine to localize the pain to the subacromial bursa (Neer's Test). A positive Neer's test is required to finalize eligibility for further participation. Participants who satisfy inclusion/exclusion criteria (including a positive Neer's test) will be randomized to high dose steroid, standard dose steroid, or low dose steroid via a computer generated random number table. The study participants and the observer will be blinded as to these groupings.
- After the initial Neer's test and randomization, participants will receive their assigned injection the same day. Participants then will be followed for an additional 12 weeks, including three follow-up visits (Visits 3-5). The total participation time in this study will be 13 weeks.
- The primary outcome measure will be the BPI 12. The BPI is a pain questionnaire, which assesses the "worst pain" in the previous 7 days. Secondary outcome measures also will be assessed together with BPI 12. There will be 3 additional secondary outcome measures, Fugl-Meyer Motor Assessment (a measure of poststroke motor impairment), pain free external rotation range of motion (ROM) and pain free abduction ROM.
- A blinded therapist will administer all outcome measures. The primary outcome will be assessed on a weekly basis via telephone (or in person during weeks of MetroHealth visits) starting on the day of Visit 1 and continuing to 12-weeks after steroid injection (i.e., for the 13 weeks of the subject's participation). The remaining secondary outcomes will be assessed in clinic visits at least every 4 weeks starting with Visit 2 (Visits 2-5).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Active comparator | Drug: Lidocaine, Drug: Triamcinolone + LidocaineDrug: Lidocaine (Neer's Test) Drug: 20 mg Triamcinolone + Lidocaine |
| Standard Dose | Active comparator | Drug: Lidocaine, Drug: Triamcinolone + LidocaineDrug: Lidocaine (Neer's Test) Drug: 40 mg Triamcinolone + Lidocaine |
| High Dose | Experimental | Drug: Lidocaine, Drug: Triamcinolone + LidocaineDrug: Lidocaine (Neer's Test) Drug: 60 mg Triamcinolone + Lidocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age greater than 18
- upper extremity hemiplegia due to hemorrhagic or nonhemorrhagic stroke
- ≤ 4/5 on manual muscle testing for the deltoid on the affected side if isolated movement is present
- post-stroke duration ≥ 1-mo, but < 24-mo
- shoulder pain sustained for ≥ 1-mo
Key exclusion criteria (14 listed)
- evidence of joint or overlying skin infection
- > 2 opioid and/or nonopioid analgesic for shoulder pain (i.e., > 2 regardless of class)
- regular intake of pain medications for any other chronic pain
- steroid injections to the shoulder in the last 6-wks
- history of pre-stroke shoulder pain
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 |
|---|---|---|
| LidocaineOne-time Screening/Eligibility Neer's Test: 5 cc of 2% lidocaine | Drug | High Dose, Low Dose, Standard Dose |
| Triamcinolone + LidocaineAlso: Kenalog = TriamcinoloneLow Dose -- One-time injection of 20 mg triamcinolone: 1.5 cc of normal saline, 0.5 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine | Drug | Low Dose |
| Triamcinolone + LidocaineAlso: Kenalog = TriamcinoloneStandard Dose -- One-time injection of 40 mg triamcinolone: 1 cc of normal saline, 1 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine | Drug | Standard Dose |
| Triamcinolone + LidocaineAlso: Kenalog = TriamcinoloneHigh Dose -- One-time injection of 60 mg triamcinolone: 0.5 cc of normal saline, 1.5 cc of 40mg/cc of triamcinolone and 2 cc of 2% lidocaine | Drug | High Dose |
Primary outcome
BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire
Time frame: Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times)
Change in BPI-12, Worst pain in the last week on 0 (No Pain) to 10 (Worst Pain Possible) scale, from baseline to week 12. The data in the Outcome Measure data table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions.
3 secondary outcomes
Fugl-Meyer Motor Assessment, Upper Limb Domain
Time frame: Baseline, weeks 4, 8, 12 (4 times)
Pain Free External Rotation Range of Motion (ROM)
Time frame: Baseline, weeks 4, 8, 12 (4 times)
Pain Free Abduction Range of Motion (ROM)
Time frame: Baseline, weeks 4, 8, 12 (4 times)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
John Chae, MD principal investigator
MetroHealth Medical Center; Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine and Triamcinolone + Lidocaine in people with Shoulder Pain, run by MetroHealth 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 8 inclusion and 14 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 13 Dec 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 13 Dec 2017). 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?
BPI 12 (Brief Pain Inventory, Question 12) Pain Questionnaire (time frame: Baseline, weeks 1, 2, 3, 4, 8, 12 (7 times)). 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 13 Dec 2017.