NCT06631976

Conservative Treatment in Patients With Supraspinatus Tendon Injury.

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Medical University of Lodz · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Rotator cuff injuries are a major cause of severe pain, often significantly impacting patients\' sleep quality. For patients waiting for surgery or those not eligible for operative treatment, conservative treatment is recommended. In cases of minor injuries, physiotherapy is as effective as surgical intervention. The aim of this study is: (1) to compare the speed, effectiveness, and durability of four implemented interventions in improving sleep quality, pain, and shoulder function, (2) to select the most optimal form of conservative treatment for patients with shoulder pain affecting sleep quality, and (3) to evaluate the expression of brain-derived neurotrophic factor (BDNF) and proBDNF (precursor) at the mRNA protein level before the planned intervention (T0), 1 month (T1), 3 months (T3), and 6 months (T6) after intervention. The study results can assist physicians and physiotherapists in providing patients with therapy that not only relieves pain and improves function but also augments sleep quality, an aspect often overlooked in the literature yet greatly impacting patients\' quality of life.

Conditions

• Supraspinatus Injury
• Sleep Disturbance

Interventions

Type	Name	Description
DRUG	1ml of Depo-Medrol® injection	1ml of methylprednisolone acetate (40mg/ml) injection into subacromial bursa.
OTHER	Rehabilitation	Rehabilitation
DRUG	Nerve block with 4ml of 2% lidocaine	Nerve block with 4ml of 2% lidocaine around the suprascapular nerve
DRUG	Tropocells® PRP injection	Tropocells® PRP injection. Patients will have an 11ml venous blood sample taken. After centrifugation, the obtained preparation will be administered to the patients intratendinously.

Timeline

• Start date: 2024-06-04
• Primary completion: 2026-05-01
• Completion: 2026-09-01
• First posted: 2024-10-08
• Last updated: 2025-12-10

Locations

1 site across 1 country: Poland