Actively Recruiting
Comparison of Conservative Treatment Methods for Sleep Disorders, Pain, and Shoulder Function in Patients With Supraspinatus Tendon Injury
Led by Medical University of Lodz · Updated on 2025-12-10
40
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Rotator cuff injuries, particularly supraspinatus tendon tears, often cause severe pain that disrupts sleep quality. This research aims to compare four conservative treatments in patients aged 40 to 75 who experience shoulder pain affecting their sleep. The study also evaluates brain-derived neurotrophic factor (BDNF) and its precursor levels at various times after treatment to better understand their role in recovery and sleep improvement. Participants will be randomly assigned to one of four groups: standardized rehabilitation alone; rehabilitation plus a corticosteroid injection into the subacromial bursa; rehabilitation plus a platelet-rich plasma (PRP) injection prepared from the patient's blood; or rehabilitation combined with a suprascapular nerve block using lidocaine. Each intervention targets pain relief, shoulder function, and sleep quality. Throughout the six-month study, participants will undergo assessments including shoulder strength and motion measurements, pain rating scales, sleep quality indexes, and BDNF protein and mRNA level evaluations. Additional tests like cognitive assessments and muscle imaging will also be performed. These evaluations will help determine which treatment best improves pain, function, and sleep for patients with supraspinatus tendon injuries.
CONDITIONS
Brief Title
Conservative Treatment in Patients With Supraspinatus Tendon Injury.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic partial incomplete thickness tear of the supraspinatus tendon, under 1 cm length and less than 50% thickness, confirmed by ultrasound
- Sleep disturbance symptoms for at least 1 month due to shoulder pain with a Pittsburgh Sleep Quality Index score above 5
- Shoulder pain disrupting sleep quality
- Body mass index (BMI) below 30
- Age between 40 and 75 years
You will not qualify if you...
- Other pain symptoms unrelated to the shoulder
- History of shoulder surgery
- Presence of psychiatric or neurological disorders
- Comorbidities that may disrupt sleep
- Risk factors impairing tissue healing such as osteoporosis, diabetes, hypercholesterolemia
- Alcohol dependence, nicotine addiction, or passive smoking
- Use of fluoroquinolone antibiotics, sleep-affecting medications, antidepressants, antipsychotics, or anxiolytics
- Lack of consent, inability to cooperate, or impaired verbal-logical communication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 6 months
Participants receive one of the following treatments: rehabilitation alone, rehabilitation combined with a corticosteroid injection, rehabilitation combined with a PRP injection, or rehabilitation combined with a nerve block.
Visits scheduled according to treatment protocol over 6 months
Trial Site Locations
Total: 1 location
1
Medical University of Lodz
Lodz, Łódź Voivodeship, Poland, 90-419
Actively Recruiting
Research Team
M
Michał Kanak, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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