Conservative Treatment in Patients With Supraspinatus Tendon Injury.

NCT ID: NCT06631976

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-04
• Study Completion Date: 2026-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Rehabilitation

Rehabilitation Treatment - a group of patients will be treated using a standardized rehabilitation protocol.

Group Type: ACTIVE_COMPARATOR

Rehabilitation

Intervention Type: OTHER

Rehabilitation

Steroid

Rehabilitation treatment combined with a subacromial corticosteroid injection. Patients will receive 1ml of methylprednisolone acetate (40mg/ml) into the subacromial-subdeltoid bursa.

Group Type: EXPERIMENTAL

1ml of Depo-Medrol® injection

Intervention Type: DRUG

1ml of methylprednisolone acetate (40mg/ml) injection into subacromial bursa.

Rehabilitation

Intervention Type: OTHER

Rehabilitation

PRP

Rehabilitation treatment combined with PRP injection. Patients will have an 11ml venous blood sample taken. After centrifugation, the obtained preparation will be administered to the patients intratendinously.

Group Type: EXPERIMENTAL

Rehabilitation

Intervention Type: OTHER

Rehabilitation

Tropocells® PRP injection

Intervention Type: DRUG

Tropocells® PRP injection. Patients will have an 11ml venous blood sample taken. After centrifugation, the obtained preparation will be administered to the patients intratendinously.

Nerve Block

Rehabilitation treatment combined with suprascapular nerve block. Patients will receive 4ml of 2% lidocaine around the suprascapular nerve.

Group Type: EXPERIMENTAL

Rehabilitation

Intervention Type: OTHER

Rehabilitation

Nerve block with 4ml of 2% lidocaine

Intervention Type: DRUG

Nerve block with 4ml of 2% lidocaine around the suprascapular nerve

Interventions

1ml of Depo-Medrol® injection

1ml of methylprednisolone acetate (40mg/ml) injection into subacromial bursa.

Intervention Type: DRUG

Rehabilitation

Rehabilitation

Intervention Type: OTHER

Nerve block with 4ml of 2% lidocaine

Nerve block with 4ml of 2% lidocaine around the suprascapular nerve

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michał Kanak, MD

Role: STUDY_CHAIR

Medical University of Lodz

Marcin Domżalski, Prof.

Role: STUDY_CHAIR

Medical University of Lodz

Locations

Medical University of Lodz

Lodz, Łódź Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Michał Kanak, MD

Role: CONTACT

michal.kanak@umed.lodz.pl

178-334-0150

Facility Contacts

Michał Kanak, MD

Role: primary

michal.kanak@umed.lodz.pl

+48 783340150

Other Identifiers

RCT-Physio-Injections-4-groups

Identifier Type: -

Identifier Source: org_study_id