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Conservative Treatment in Patients With Supraspinatus Tendon Injury.

NCT06631976 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-10

No results posted yet for this 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.

Conditions

  • Supraspinatus Injury
  • Sleep Disturbance

Interventions

DRUG

1ml of Depo-Medrol® injection

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

OTHER

Rehabilitation

Rehabilitation

DRUG

Nerve block with 4ml of 2% lidocaine

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

DRUG

Tropocells® 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.

Sponsors & Collaborators

  • Medical University of Lodz

    lead OTHER

Principal Investigators

  • Michał Kanak, MD · Medical University of Lodz

  • Marcin Domżalski, Prof. · Medical University of Lodz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-04
Primary Completion
2026-05-01
Completion
2026-09-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06631976 on ClinicalTrials.gov