Acute PainNCT02971072
Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy
A study testing Subacromial injection and Physical Therapy in people with Acute Pain and Atrophic, run by University of Oregon at 1 site in United States.
Trial summary
The purpose of this study is to examine deficits in activation and motor patterns, as well as central drive in patients with rotator cuff tendinopathy. There are three specific aims: (1) determine the effect of acute pain relief on rotator cuff muscle activation in patients with rotator cuff tendinopathy, (2)… Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Atrophic, Goals
- What is being tested?
- Subacromial injection and Physical Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Apr 2021
- 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 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Patient Inclusion Criteria:
- pain with passive provocative maneuvers (positive Hawkins or Neer test)
- pain with active elevation (positive painful arc)
- pain with isometric resisted movements (Jobe's "empty can" test or resisted shoulder external rotation with the arm at the side)
- demonstrate weakness (>10% force deficit in external rotation)
Patient Exclusion Criteria:
- shoulder surgery on the symptomatic side
- positive Spurling test
- traumatic shoulder dislocation or instability in the past 3 months
- reproduction of shoulder pain with active or passive cervical range of motion
- signs of rotator cuff tear (drop-arm test, lag signs, gross external rotation weakness, or positive image findings)
- current musculoskeletal, neurologic or cardiovascular compromise
Control Inclusion Criteria:
- no current or previous shoulder injury
- matched for age (within 5 years) and sex
- meet Patient Exclusion Criteria (minus musculoskeletal, neurologic, or cardiovascular compromise)
Control Exclusion Criteria:
- pain with active arm elevation
- positive Hawkins, Neer, or Jobe's test
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine deficits in activation and motor patterns, as well as central drive in patients with rotator cuff tendinopathy. There are three specific aims: (1) determine the effect of acute pain relief on rotator cuff muscle activation in patients with rotator cuff tendinopathy, (2) determine the effect of exercise on rotator cuff muscle activation in patients with rotator cuff tendinopathy, and (3) compare rotator cuff muscle activation between patients with rotator cuff tendinopathy and healthy controls.
Read the detailed description
The long-term goal of our research agenda is to identify the mechanisms associated with rotator cuff tendinopathy (impingement syndrome) and subsequently evaluate novel treatment strategies that address these mechanisms. The objectives of this application are to study the muscle patterns in patients with rotator cuff tendinopathy as well as the effects of both pain and exercise on these patterns. Our first hypothesis is that pain relief from a shoulder injection will result in increased rotator cuff activity. Our second hypothesis is that patients with tendinopathy will demonstrate improved rotator cuff muscle activity following a six-week exercise program and that this improvement will be higher in patients that respond favorably to treatment. Our final hypothesis is that patients with cuff tendinopathy will show decreased rotator cuff activity compared to healthy subjects. The investigators plan on addressing these hypotheses using several novel techniques for muscle activity assessment.
- Conditions
- Acute Pain, Atrophic, Goals, Impairment, Infiltration, Injury
- Being tested
- Subacromial injection, Physical Therapy
- Keywords
- address, atrophic, base, clinical, cost, data, disability, effectiveness, attention, biofeedback, electrical stimulation, electromyography, exercise, exertion, health care service utilization, improved, injection of therapeutic agent, innovation, intervention, knowledge
- Medical subject headings
- Acute Pain, Atrophy, Wounds and Injuries, Muscle Weakness, Pain, Shoulder Pain, Syndrome, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subacromial injectionProcedure or surgery
A subacromial injection consisting up 6 cc 0.5% Marcaine with Epinephrine and 1 cc DepoMedrol will be administered.
Physical TherapyOther
A standardized six-week exercise protocol supervised by a physical therapist
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Subjects with shoulder tendinopathy who will undergo both a subacromial injection and physical therapy Receives: Procedure: Subacromial injection; Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotator cuff activation after subacromial injection and exercise intervention, difference in rotator cuff voluntary activation between subjects and controls
Assessed using voluntary activation
Measured: 6 weeks
Rotator cuff activation after subacromial injection and exercise intervention, difference in specific rotator cuff muscle activation between subjects and controls
Assessed using electromyography (EMG)
Measured: 6 weeks
Secondary outcomes (14)
Rotator cuff voluntary activation after subacromial injection
Assessed using voluntary activation
Measured: 2 hours
Rotator cuff muscle activation after subacromial injection
Assessed using EMG
Measured: 2 hours
Rotator cuff voluntary activation correlations with pain levels
Assessed using voluntary activation relative to self-reported pain level
Measured: 2 hours
Rotator cuff activation correlations with pain levels
Assessed using EMG relative to self-reported pain level
Measured: 2 hours
Rotator cuff voluntary activation after 6-week exercise intervention and subacromial injection
Assessed using voluntary activation
Measured: 6 weeks
Rotator cuff muscle activation after 6-week exercise intervention and subacromial injection
Assessed using EMG
Measured: 6 weeks
Rotator cuff voluntary activation correlation with improvements in pain relief
Assessed using voluntary activation relative to self-reported pain relief
Measured: 6 weeks
Rotator cuff voluntary activation correlation with improvements in clinical outcome measures
Assessed using voluntary activation relative to changes in questionnaire scores
Measured: 6 weeks
Rotator cuff muscle activation correlation with improvements in pain relief
Assessed using EMG relative to self-reported pain relief
Measured: 6 weeks
Rotator cuff muscle activation correlation with improvements in clinical outcome measures
Assessed using EMG relative to changes in questionnaire scores
Measured: 6 weeks
Prior to treatment, rotator cuff voluntary activation in patients relative to healthy controls
Assessed using voluntary activation
Measured: 6 weeks
Prior to treatment, rotator cuff muscle activation in patients relative to healthy controls
Assessed using EMG
Measured: 6 weeks
After both a subacromial injection and a six-week exercise program, differences in rotator cuff voluntary activation between patients and healthy controls
Assessed using voluntary activation
Measured: 6 weeks
After both a subacromial injection and a six-week exercise program, differences in rotator cuff muscle activation between patients and healthy controls
Assessed using EMG
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 posted22 Nov 2016 (estimated)
- Study startJul 2014
- Primary completionApr 2021
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Andrew R Karduna, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971072
- Sponsor's protocol ID
- 05022014.005
- Other IDs
- 1R01AR063713-01A1
- Status last verified
- Mar 2020
- First submitted
- 10 May 2016
- Last updated
- 13 Sep 2022
- 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 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy
- ClinicalTrials.gov ID
- NCT02971072
- Acronym / sponsor ID
- 05022014.005
- Conditions
- Acute Pain, Atrophic, Goals, Impairment, Infiltration, Injury
- Keywords
- address, atrophic, base, clinical, cost, data, disability, effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jul 2014 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 22 Nov 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.
The purpose of this study is to examine deficits in activation and motor patterns, as well as central drive in patients with rotator cuff tendinopathy. There are three specific aims: (1) determine the effect of acute pain relief on rotator cuff muscle activation in patients with rotator cuff tendinopathy, (2) determine the effect of exercise on rotator cuff muscle activation in patients with rotator cuff tendinopathy, and (3) compare rotator cuff muscle activation between patients with rotator cuff tendinopathy and healthy controls.
Detailed description
The long-term goal of our research agenda is to identify the mechanisms associated with rotator cuff tendinopathy (impingement syndrome) and subsequently evaluate novel treatment strategies that address these mechanisms. The objectives of this application are to study the muscle patterns in patients with rotator cuff tendinopathy as well as the effects of both pain and exercise on these patterns. Our first hypothesis is that pain relief from a shoulder injection will result in increased rotator cuff activity. Our second hypothesis is that patients with tendinopathy will demonstrate improved rotator cuff muscle activity following a six-week exercise program and that this improvement will be higher in patients that respond favorably to treatment. Our final hypothesis is that patients with cuff tendinopathy will show decreased rotator cuff activity compared to healthy subjects. The investigators plan on addressing these hypotheses using several novel techniques for muscle activity assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: Subacromial injection, Other: Physical TherapySubjects with shoulder tendinopathy who will undergo both a subacromial injection and physical therapy |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Subacromial injectionA subacromial injection consisting up 6 cc 0.5% Marcaine with Epinephrine and 1 cc DepoMedrol will be administered. | Procedure or surgery | Patients |
| Physical TherapyA standardized six-week exercise protocol supervised by a physical therapist | Other | Patients |
Primary outcome
Rotator cuff activation after subacromial injection and exercise intervention, difference in rotator cuff voluntary activation between subjects and controls
Time frame: 6 weeks
Assessed using voluntary activation
Rotator cuff activation after subacromial injection and exercise intervention, difference in specific rotator cuff muscle activation between subjects and controls
Time frame: 6 weeks
Assessed using electromyography (EMG)
14 secondary outcomes
Rotator cuff voluntary activation after subacromial injection
Time frame: 2 hours
Rotator cuff muscle activation after subacromial injection
Time frame: 2 hours
Rotator cuff voluntary activation correlations with pain levels
Time frame: 2 hours
Rotator cuff activation correlations with pain levels
Time frame: 2 hours
Rotator cuff voluntary activation after 6-week exercise intervention and subacromial injection
Time frame: 6 weeks
Rotator cuff muscle activation after 6-week exercise intervention and subacromial injection
Time frame: 6 weeks
Rotator cuff voluntary activation correlation with improvements in pain relief
Time frame: 6 weeks
Rotator cuff voluntary activation correlation with improvements in clinical outcome measures
Time frame: 6 weeks
Rotator cuff muscle activation correlation with improvements in pain relief
Time frame: 6 weeks
Rotator cuff muscle activation correlation with improvements in clinical outcome measures
Time frame: 6 weeks
Prior to treatment, rotator cuff voluntary activation in patients relative to healthy controls
Time frame: 6 weeks
Prior to treatment, rotator cuff muscle activation in patients relative to healthy controls
Time frame: 6 weeks
After both a subacromial injection and a six-week exercise program, differences in rotator cuff voluntary activation between patients and healthy controls
Time frame: 6 weeks
After both a subacromial injection and a six-week exercise program, differences in rotator cuff muscle activation between patients and healthy controls
Time frame: 6 weeks
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 13 Sep 2022.
- 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.
Andrew R Karduna, PhD principal investigator
University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subacromial injection and Physical Therapy in people with Acute Pain and Atrophic, run by University of Oregon 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 13 Sep 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 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?
Rotator cuff activation after subacromial injection and exercise intervention, difference in rotator cuff voluntary activation between subjects and controls (time frame: 6 weeks). The study lists 2 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 13 Sep 2022.