NCT06631976 Conservative Treatment in Patients With Supraspinatus Tendon Injury.
| NCT ID | NCT06631976 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Lodz |
| Condition | Supraspinatus Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-06-04 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-06-04 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Michał Kanak, MD
STUDY CHAIR
Medical University of Lodz
Frequently Asked Questions
Who can join the NCT06631976 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Supraspinatus Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06631976 currently recruiting?
Yes, NCT06631976 is actively recruiting participants. Contact the research team at michal.kanak@umed.lodz.pl for enrollment information.
Where is the NCT06631976 trial being conducted?
This trial is being conducted at Lodz, Poland.
Who is sponsoring the NCT06631976 clinical trial?
NCT06631976 is sponsored by Medical University of Lodz. The principal investigator is Michał Kanak, MD at Medical University of Lodz. The trial plans to enroll 40 participants.