Conservative Treatment in Patients with Supraspinatus Tendon Injury.

Medical University of Lodz

Status: Enrolling

Conditions: Supraspinatus Injury; Sleep Disturbance

Treatments: Drug: Tropocells® PRP injection; Drug: 1ml of Depo-Medrol® injection; Drug: Nerve block with 4ml of 2% lidocaine; Other: Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06631976

RCT-Physio-Injections-4-groups

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 4 patient groups

Rehabilitation

Active Comparator group

Description:

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

Treatment:

Other: Rehabilitation

Steroid

Experimental group

Description:

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

Treatment:

Other: Rehabilitation

Drug: 1ml of Depo-Medrol® injection

PRP

Experimental group

Description:

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.

Treatment:

Other: Rehabilitation

Drug: Tropocells® PRP injection

Nerve Block

Experimental group

Description:

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

Treatment:

Other: Rehabilitation

Drug: Nerve block with 4ml of 2% lidocaine