RecruitingNot ApplicableNCT06631976

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.


Sponsor

Medical University of Lodz

Enrollment

40 participants

Start Date

Jun 4, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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.
  • Sleep disturbance symptoms for at least 1 month due to shoulder pain - PSQI score > 5.
  • Shoulder pain disrupting the quality of sleep.
  • BMI < 30.
  • Age 40-75.

Exclusion Criteria8

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

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Interventions

DRUG1ml of Depo-Medrol® injection

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

OTHERRehabilitation

Rehabilitation

DRUGNerve block with 4ml of 2% lidocaine

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

DRUGTropocells® 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.


Locations(1)

Medical University of Lodz

Lodz, Łódź Voivodeship, Poland

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NCT06631976


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