Dry Needling and Exercise Versus Traditional Physical Therapy for Biceps Tendinitis (NCT04073212) | Clinical Trial Compass
WithdrawnNot Applicable
Dry Needling and Exercise Versus Traditional Physical Therapy for Biceps Tendinitis
Stopped: Withdrawn due to inability to recruit and enroll during COVID-19
United States0Started 2022-09
Plain-language summary
The aim of the research is to determine if participants who receive physical therapy (physiotherapy) including soft tissue mobilization, dry needling, Heavy slow load (eccentric-concentric) exercise (with hand weights specific to the biceps muscle) and a comprehensive rotator cuff and scapular stabilization program achieve greater reductions in pain and disability in the short (3-4 weeks) and long term (6 months) compared to those who receive soft tissue mobilization and a comprehensive rotator cuff and scapular stabilization program. Both treatment approaches are within the standard of care for physical therapists, the aim being to determine the most effective treatment approach. Study participants will be recruited form clinicians and flyers within the university/hospital organization where the study is taking place. Participants will be asked to attend 6 physical therapy visits and complete 6 surveys about their pain and disability.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-64 years old
* Primary diagnosis of bicipital tendinopathy
* Primary complaint of anterior shoulder pain in the area of the LHBT
* Clinical exam findings (must have positive findings for at least 1/2 of the following: Speed's Test, Yergason's test for biceps tendon pain.
* Pain with palpation in area of the biceps tendon
* Patient identification of pain in the area of the proximal biceps tendon
* NPRS of at least 3/10 at worst in the past week
Exclusion Criteria:
* History of biceps tendon injection in the past 3 months
* History of rotator cuff surgery
* History of biceps tenodesis or tenotomy
* History of bleeding disorder or anti-coagulation therapy
* Diagnosis of adhesive capsulitis (as defined by 50% loss of range of motion in 2 out of 3 of the following motions: Shoulder flexion, abduction and external rotation)
* Known underlying non-modifiable medical condition (e.g. tumor, fracture, metabolic disease)
* Two or more positive neurological signs consistent with nerve root compression
* Known allergy to metal
* Participant reported aversion to needles
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
American Shoulder and Elbow Surgeons Scale (ASES) at Baseline
Timeframe: Baseline
2
American Shoulder and Elbow Surgeons Scale (ASES) at 3 Weeks
Timeframe: 3 weeks
3
American Shoulder and Elbow Surgeons Scale (ASES) at 12 Weeks
Timeframe: 12 weeks
4
American Shoulder and Elbow Surgeons Scale (ASES) at 6 Months