Conservative Treatment in Patients with Supraspinatus Tendon Injury.

Last updated: October 7, 2024
Sponsor: Medical University of Lodz
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Restless Leg Syndrome

Tendon Injuries

Treatment

Tropocells® PRP injection

Rehabilitation

1ml of Depo-Medrol® injection

Clinical Study ID

NCT06631976
RCT-Physio-Injections-4-groups
  • Ages 40-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Symptomatic partial incomplete thickness tear of the supraspinatus tendon, with alength below 1 cm and not exceeding 50% of the tendon thickness, confirmed byultrasound examination.

  2. Sleep disturbance symptoms for at least 1 month due to shoulder pain - PSQI score >

  4. Shoulder pain disrupting the quality of sleep.

  5. BMI < 30.

  6. Age 40-75.

Exclusion

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 likelihoodof injury progression - osteoporosis, diabetes, hypercholesterolemia.

  6. Alcohol dependence, nicotine addiction, passive smoking.

  7. Taking antibiotics from the fluoroquinolone group, sleep-affecting medications (suchas melatonin, trazodone, zolpidem), antidepressants, antipsychotics, anxiolytics.

  8. Lack of patient consent, lack of cooperation, or impaired verbal-logicalcommunication.

Study Design

Total Participants: 40
Treatment Group(s): 4
Primary Treatment: Tropocells® PRP injection
Phase:
Study Start date:
June 04, 2024
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Medical University of Lodz

    Lodz, 90-419
    Poland

    Active - Recruiting

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