Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
NCT06631976

Conservative Treatment in Patients With Supraspinatus Tendon Injury.

Led by Medical University of Lodz · Updated on 2025-12-10

40

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Conservative Treatment in Patients With Supraspinatus Tendon Injury.

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Partial incomplete tear of the supraspinatus tendon less than 1 cm and under 50% thickness confirmed by ultrasound
  • Sleep disturbance symptoms lasting at least 1 month due to shoulder pain with PSQI score over 5
  • Shoulder pain that disrupts sleep quality
  • Body mass index (BMI) less than 30
  • Age between 40 and 75 years
Not Eligible

You will not qualify if you...

  • Other pain symptoms besides shoulder pain
  • History of shoulder surgery
  • Psychiatric or neurological disorders
  • Comorbidities that may disrupt sleep
  • Risk factors impairing tissue healing such as osteoporosis, diabetes, or high cholesterol
  • Alcohol dependence, nicotine addiction, or passive smoking
  • Use of fluoroquinolone antibiotics, sleep-affecting medications, antidepressants, antipsychotics, or anxiolytics
  • Lack of consent, cooperation, or impaired verbal-logical communication

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical University of Lodz

Lodz, Łódź Voivodeship, Poland, 90-419

Actively Recruiting

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Research Team

M

Michał Kanak, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Conservative Treatment in Patients With Supraspinatus Tendon Injury. | DecenTrialz