Treatment options for shoulder injuries affecting sleep quality

Comparison of Conservative Treatment Methods for Sleep Disorders, Pain, and Shoulder Function in Patients With Supraspinatus Tendon Injury.

This study is testing four different treatments for people with shoulder injuries to see which one helps improve their sleep quality and reduce pain.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: Medical University of Lodz (other)
• Locations: 1 site (Lodz, Łódź Voivodeship)
• Trial ID: NCT06631976 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of four conservative treatment interventions for patients with supraspinatus tendon injuries who experience sleep disturbances due to shoulder pain. The interventions include a Depo-Medrol® injection, rehabilitation, a nerve block with lidocaine, and Tropocells® PRP injection. The study aims to compare the speed, effectiveness, and durability of these treatments in improving sleep quality, pain, and shoulder function. Additionally, it will assess the expression of brain-derived neurotrophic factor (BDNF) at various time points before and after the interventions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-75 with symptomatic partial tears of the supraspinatus tendon and sleep disturbances related to shoulder pain.

Not a fit: Patients with significant comorbidities, prior shoulder surgeries, or those with psychiatric or neurological disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with effective non-surgical treatment options that improve both pain management and sleep quality.

How similar studies have performed: Other studies have shown that conservative treatments can be effective for similar conditions, suggesting a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Symptomatic partial incomplete thickness tear of the supraspinatus tendon, with a length below 1 cm and not exceeding 50% of the tendon thickness, confirmed by ultrasound examination.
2. Sleep disturbance symptoms for at least 1 month due to shoulder pain - PSQI score \> 5.
3. Shoulder pain disrupting the quality of sleep.
4. BMI \< 30.
5. Age 40-75.

Exclusion Criteria:

1. Other accompanying pain symptoms.
2. History of shoulder surgery.
3. Coexistence of psychiatric or neurological disorders.
4. Presence of comorbidities that may disrupt sleep.
5. Presence of risk factors impairing tissue regeneration and increasing the likelihood of injury progression - osteoporosis, diabetes, hypercholesterolemia.
6. Alcohol dependence, nicotine addiction, passive smoking.
7. Taking antibiotics from the fluoroquinolone group, sleep-affecting medications (such as melatonin, trazodone, zolpidem), antidepressants, antipsychotics, anxiolytics.
8. Lack of patient consent, lack of cooperation, or impaired verbal-logical communication.

Where this trial is running

Lodz, Łódź Voivodeship

• Medical University of Lodz — Lodz, Łódź Voivodeship, Poland (RECRUITING)

Study contacts

• Study coordinator: Michał Kanak, MD

Conditions: Supraspinatus Injury, Sleep Disturbance