Shoulder Impingement SyndromeNCT02686671
The Pull Test To Determine Responders To Subacromial Injection In Patients With Shoulder Impingement
An observational study of Shoulder Impingement Syndrome, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial summary
Shoulder pain is very common. People receive injections in their shoulder for their painful shoulder. However, investigators do not know which patient with shoulder pain responds best to an injection in the shoulder. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Shoulder clinical examination testing
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2018
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A consecutive sample of convenience of subjects treated by physicians from Advanced Pain Centers of Alaska for musculoskeletal shoulder pain and scheduled for a subacromial CSI as part of their care will be asked to participate in the study. The study will end when a minimum of 30 subjects qualify for the research study.
Inclusion Criteria: Subjects will be eligible for both phases of the study if they meet the following criteria:
- age 18 to 80 years
- demonstrate shoulder pain within the C5 distribution during resisted abduction between 2 and 10/10 on NRPS (Wainner et al 2003)
- demonstrate one or more positive tests out of the following clinical examination impingement tests: Neer's sign, Hawkins-Kennedy test, painful arc of arm elevation (Kessel \& Watson 1977; Kelly et al 2010)
- painful resisted abduction of the shoulder (Kelly et al 2010)
Exclusion Criteria: Subjects will be excluded from the study for the following reasons:
- a large three-dimensional limitation of arm motion with any passive motion of the shoulder as compared to the contralateral side, to rule out adhesive capsulitis (Rundquist \& Ludewig 2004; Tveita et al 2008)
- shoulder surgery within the last six months
- a CSI to the involved shoulder within the past three months
- presence of a systemic inflammatory condition
- presence of radiculopathy during active range of motion of the cervical spine (Wainner et al 2003)
- cervical spine as a current primary complaint over the shoulder
- pain reproduction during the Spurling Test (Henry et al 2002; Wainner et al 2003)
- inability to undergo a follow-up phone call
- neurological disorders such as multiple sclerosis, spinal cord injury or spinal cord tumors that would prevent subjects to elevate the arm above the head or perform shoulder movements against resistance
- pregnancy by self-report from the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Diagnostic Clinical Test To Determine Responders To Subacromial Injection In Patients With Shoulder Impingement: A Case Series
Shoulder pain is very common. People receive injections in their shoulder for their painful shoulder. However, investigators do not know which patient with shoulder pain responds best to an injection in the shoulder.
Investigators plan to use a "Pull Test" where the researcher will pull on the arm and resist shoulder movement to investigate if it helps to determine which patients have better pain relief with the shoulder injection.
Read more
The study will take place in Anchorage, Alaska. There will be two phases in the study. For each phase, the subjects will complete some questionnaires. Phase I "Reliability Testing" will test how consistent two licensed physical therapists are giving shoulder examination tests and the Pull Test. Phase II "Pull Test" will comprise shoulder examination findings, including the Pull Test, done before and after one shoulder injection performed as normal standard of care by a licensed physician.
For Phase I of the study, up to 20 patients treated for shoulder pain will be recruited from Advanced Physical Therapy. For Phase II of the study, up to 100 patients with shoulder pain scheduled to have a shoulder injection will be asked by an investigator if they wish to participate in the study until a number of 30 subjects qualify for the study. Phase II of the study will include shoulder tests before and about 20 minutes after the injection and a 4- to 7-day, as well as a 6-week, phone follow-up.
Statistics will be used to analyze the data.
Read the detailed description
Background: Subacromial impingement syndrome (SAIS) is one of the most common causes of shoulder pain. The subacromial-subdeltoid (SAD) bursa is regarded as a common potential shoulder pain generator. Differentiating the specific acromio-humeral interval (AHI) tissues responsible for pain generation is challenging and no specific clinical examination testing exists to differentiate SAD bursa from the rotator cuff tendons as pain generators. Corticosteroid injection (CSI) within the AHI is a mainstay of treatment for SAD bursitis and rotator cuff tendinopathy. No study to date has examined a specific test associated with successful responsiveness from a CSI targeting the SAD bursa in the AHI in subjects with shoulder pain.
Purpose: To investigate (1) Phase I: the reliability of the shoulder examination tests and of the Pull Test; and (2) Phase II: if a positive shoulder traction test during resistive shoulder abduction, the "Pull Test", correlates with a successful outcome of an AHI CSI targeting the SAD bursa.
Aims: To evaluate: (1) the reliability of the Pull Test; (2) if a positive Pull Test correlates with successful pain and satisfaction outcomes immediately following, 4 to 7 days following, and 6 weeks following an AHI CSI targeting the SAD bursa in subjects with musculoskeletal shoulder pain (3) if a positive Pull Test correlates with a successful functional outcome 6 weeks following an AHI CSI targeting the SAD bursa in subjects with musculoskeletal shoulder pain and (4) the sensitivity, specificity, accuracy, positive and negative predictive values of the Pull Test to identify subjects with shoulder pain likely to successfully respond to an AHI CSI targeting the SAD bursa
Design: Methodological and exploratory correlational study.
Methods: Phase I (reliability testing): A sample of convenience of up to 20 subjects treated at Advanced Physical Therapy of Alaska for shoulder pain will be recruited to participate. Two licensed physical therapists will test the reliability of the shoulder examination tests and of the Pull Test. Phase II (Pull Test): A consecutive sample of convenience of subjects treated by physicians from Advanced Pain Centers of Alaska for musculoskeletal shoulder pain and scheduled for a subacromial CSI as part of their care will be asked to participate in the study. The study will end when a minimum of 30 subjects qualify for the research study. Those subjects agreeing to participate will then be evaluated using shoulder clinical examination including resistive shoulder abduction with and without a humeral traction (Pull Test). Functional status will be measured using the Shoulder Pain and Disability Index (SPADI). Following the CSI, one investigator blinded to the results of the pre-injection clinical examination will administer the clinical examination tests performed prior to the AHI CSI and record shoulder pain (NPRS) and subject satisfaction about the change in pain following the CSI. Subjects will then receive standardized home instructions. A 4- to 7-day follow-up phone call to determine shoulder pain (NPRS) and satisfaction and 6-week follow-up phone call to determine satisfaction and subjects' compliance to the home instructions, shoulder pain (NPRS) at rest and during arm elevation, SPADI score and subject satisfaction will be initiated.
Statistical Analysis: Reliability testing will be assessed using kappa and intraclass correlation coefficients. Validity testing of the Pull Test will be performed to determine the sensitivity, specificity, accuracy, negative and positive predictive values for the comparison of Pull Test outcome and the pain and functional changes observed following administration of the AHI CSI. Chi-square (2x2 contingency tables) and odds ratios will then be calculated to evaluate if the outcomes of the Pull Test (binary: positive versus negative) are correlated with successful pain and functional outcome changes following the AHI CSI (successful outcome, Yes versus No) immediately following, at 4- to 7-days following, and at 6-weeks following the AHI CSI.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Shoulder clinical examination testing
- Keywords
- Bursitis, Injections, Shoulder Pain
- Medical subject headings
- Shoulder Impingement Syndrome, Bursitis, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder clinical examination testingOther
Shoulder clinical examination including resistive shoulder abduction with and without a humeral traction (Pull Test). Functional status will be measured using the Shoulder Pain and Disability Index (SPADI).
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (NPRS)
Pain recording pre-injection
Measured: 10-30 minutes
SPADI
Shoulder function pre-injection
Measured: Immediately pre-injection
Pain (NPRS)
Pain recording immediately post-injection
Measured: Immediately post-injection
Patient Satisfaction
Patient satisfaction immediately post-injection based on 5-point Likert Scale
Measured: Immediately post-injection
Pain (NPRS)
Pain recording 4-7 days post-injection
Measured: 4-7 days
Patient Satisfaction
Patient satisfaction 4-7 days post-injection based on 5-point Likert Scale
Measured: 4-7 days
Pain (NPRS)
Pain recording 6-weeks post-injection
Measured: 6-weeks
SPADI
Shoulder function 6-weeks post-injection
Measured: 6-weeks
Patient Satisfaction
Patient satisfaction 6-weeks post-injection based on 5-point Likert Scale
Measured: 6-weeks
Subjective Outcome of Success of Injection Assessed by Survey Question
Subjective assessment of successful outcome of shoulder injection using "Yes", "Unsure" and "No" as items
Measured: Immediately post-injection
Subjective Outcome of Success of Injection Assessed by Survey Question
Subjective assessment of successful outcome of shoulder injection using "Yes", "Unsure" and "No" as items
Measured: 4-7 days
Subjective Outcome of Success of Injection Assessed by Survey Question
Subjective assessment of successful outcome of shoulder injection using "Yes", "Unsure" and "No" as items
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel Brismee, ScD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686671
- Sponsor's protocol ID
- L16-047
- Status last verified
- Jan 2020
- First submitted
- 20 Jan 2016
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Diagnostic Clinical Test To Determine Responders To Subacromial Injection In Patients With Shoulder Impingement: A Case Series
- ClinicalTrials.gov ID
- NCT02686671
- Acronym / sponsor ID
- L16-047
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- Bursitis, Injections, Shoulder Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 19 Feb 2016 (estimated)
- 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.
Shoulder pain is very common. People receive injections in their shoulder for their painful shoulder. However, investigators do not know which patient with shoulder pain responds best to an injection in the shoulder.
Investigators plan to use a "Pull Test" where the researcher will pull on the arm and resist shoulder movement to investigate if it helps to determine which patients have better pain relief with the shoulder injection.
The study will take place in Anchorage, Alaska. There will be two phases in the study. For each phase, the subjects will complete some questionnaires. Phase I "Reliability Testing" will test how consistent two licensed physical therapists are giving shoulder examination tests and the Pull Test. Phase II "Pull Test" will comprise shoulder examination findings, including the Pull Test, done before and after one shoulder injection performed as normal standard of care by a licensed physician.
For Phase I of the study, up to 20 patients treated for shoulder pain will be recruited from Advanced Physical Therapy. For Phase II of the study, up to 100 patients with shoulder pain scheduled to have a shoulder injection will be asked by an investigator if they wish to participate in the study until a number of 30 subjects qualify for the study. Phase II of the study will include shoulder tests before and about 20 minutes after the injection and a 4- to 7-day, as well as a 6-week, phone follow-up.
Statistics will be used to analyze the data.
Detailed description
Background: Subacromial impingement syndrome (SAIS) is one of the most common causes of shoulder pain. The subacromial-subdeltoid (SAD) bursa is regarded as a common potential shoulder pain generator. Differentiating the specific acromio-humeral interval (AHI) tissues responsible for pain generation is challenging and no specific clinical examination testing exists to differentiate SAD bursa from the rotator cuff tendons as pain generators. Corticosteroid injection (CSI) within the AHI is a mainstay of treatment for SAD bursitis and rotator cuff tendinopathy. No study to date has examined a specific test associated with successful responsiveness from a CSI targeting the SAD bursa in the AHI in subjects with shoulder pain.
Purpose: To investigate (1) Phase I: the reliability of the shoulder examination tests and of the Pull Test; and (2) Phase II: if a positive shoulder traction test during resistive shoulder abduction, the "Pull Test", correlates with a successful outcome of an AHI CSI targeting the SAD bursa.
Aims: To evaluate: (1) the reliability of the Pull Test; (2) if a positive Pull Test correlates with successful pain and satisfaction outcomes immediately following, 4 to 7 days following, and 6 weeks following an AHI CSI targeting the SAD bursa in subjects with musculoskeletal shoulder pain (3) if a positive Pull Test correlates with a successful functional outcome 6 weeks following an AHI CSI targeting the SAD bursa in subjects with musculoskeletal shoulder pain and (4) the sensitivity, specificity, accuracy, positive and negative predictive values of the Pull Test to identify subjects with shoulder pain likely to successfully respond to an AHI CSI targeting the SAD bursa
Design: Methodological and exploratory correlational study.
Methods: Phase I (reliability testing): A sample of convenience of up to 20 subjects treated at Advanced Physical Therapy of Alaska for shoulder pain will be recruited to participate. Two licensed physical therapists will test the reliability of the shoulder examination tests and of the Pull Test. Phase II (Pull Test): A consecutive sample of convenience of subjects treated by physicians from Advanced Pain Centers of Alaska for musculoskeletal shoulder pain and scheduled for a subacromial CSI as part of their care will be asked to participate in the study. The study will end when a minimum of 30 subjects qualify for the research study. Those subjects agreeing to participate will then be evaluated using shoulder clinical examination including resistive shoulder abduction with and without a humeral traction (Pull Test). Functional status will be measured using the Shoulder Pain and Disability Index (SPADI). Following the CSI, one investigator blinded to the results of the pre-injection clinical examination will administer the clinical examination tests performed prior to the AHI CSI and record shoulder pain (NPRS) and subject satisfaction about the change in pain following the CSI. Subjects will then receive standardized home instructions. A 4- to 7-day follow-up phone call to determine shoulder pain (NPRS) and satisfaction and 6-week follow-up phone call to determine satisfaction and subjects' compliance to the home instructions, shoulder pain (NPRS) at rest and during arm elevation, SPADI score and subject satisfaction will be initiated.
Statistical Analysis: Reliability testing will be assessed using kappa and intraclass correlation coefficients. Validity testing of the Pull Test will be performed to determine the sensitivity, specificity, accuracy, negative and positive predictive values for the comparison of Pull Test outcome and the pain and functional changes observed following administration of the AHI CSI. Chi-square (2x2 contingency tables) and odds ratios will then be calculated to evaluate if the outcomes of the Pull Test (binary: positive versus negative) are correlated with successful pain and functional outcome changes following the AHI CSI (successful outcome, Yes versus No) immediately following, at 4- to 7-days following, and at 6-weeks following the AHI CSI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A consecutive sample of convenience of subjects treated by physicians from Advanced Pain Centers of Alaska for musculoskeletal shoulder pain and scheduled for a subacromial CSI as part of their care will be asked to participate in the study. The study will end when a minimum of 30 subjects qualify for the research study.
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 |
|---|---|---|
| Shoulder clinical examination testingShoulder clinical examination including resistive shoulder abduction with and without a humeral traction (Pull Test). Functional status will be measured using the Shoulder Pain and Disability Index (SPADI). | Other | – |
Primary outcome
Pain (NPRS)
Time frame: 10-30 minutes
Pain recording pre-injection
SPADI
Time frame: Immediately pre-injection
Shoulder function pre-injection
Pain (NPRS)
Time frame: Immediately post-injection
Pain recording immediately post-injection
Patient Satisfaction
Time frame: Immediately post-injection
Patient satisfaction immediately post-injection based on 5-point Likert Scale
Pain (NPRS)
Time frame: 4-7 days
Pain recording 4-7 days post-injection
Patient Satisfaction
Time frame: 4-7 days
Patient satisfaction 4-7 days post-injection based on 5-point Likert Scale
Pain (NPRS)
Time frame: 6-weeks
Pain recording 6-weeks post-injection
SPADI
Time frame: 6-weeks
Shoulder function 6-weeks post-injection
Patient Satisfaction
Time frame: 6-weeks
Patient satisfaction 6-weeks post-injection based on 5-point Likert Scale
Subjective Outcome of Success of Injection Assessed by Survey Question
Time frame: Immediately post-injection
Subjective assessment of successful outcome of shoulder injection using "Yes", "Unsure" and "No" as items
Subjective Outcome of Success of Injection Assessed by Survey Question
Time frame: 4-7 days
Subjective assessment of successful outcome of shoulder injection using "Yes", "Unsure" and "No" as items
Subjective Outcome of Success of Injection Assessed by Survey Question
Time frame: 6-weeks
Subjective assessment of successful outcome of shoulder injection using "Yes", "Unsure" and "No" as items
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 23 Jan 2020.
- 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.
Jean-Michel Brismee, ScD principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Impingement Syndrome, run by Texas Tech University Health Sciences 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?
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 23 Jan 2020. 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.
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?
Pain (NPRS) (time frame: 10-30 minutes). The study lists 12 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 23 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.