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Recruiting NCT06631976

Conservative Treatment in Patients With Supraspinatus Tendon Injury.

No phase Interventional Supraspinatus Injury Sleep Disturbance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 1ml of Depo-Medrol® injection, Rehabilitation, Nerve block with 4ml of 2% lidocaine, Tropocells® PRP injection.
Who it may be relevant to
Registry conditions: Supraspinatus Injury, Sleep Disturbance. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of Conservative Treatment Methods for Sleep Disorders, Pain, and Shoulder Function in Patients With Supraspinatus Tendon Injury.

Overview

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.

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.

Primary outcome measures

  • Constant-Murley Score [Time frame: 6 months]
  • Numeric pain Rating Scale [Time frame: 6 months]
  • Range of motion measurements [Time frame: 6 months]
  • Strength measurements [Time frame: 6 months]
  • BDNF and proBDNF Assessment [Time frame: 6 months]
  • Pittsburgh Sleep Quality Index [Time frame: 6 months]
Secondary outcome measures (10)
  • The Laitinen Pain Scale [Time frame: 6 months]
  • The Simple Shoulder Test [Time frame: 6 months]
  • The American Shoulder and Elbow Surgeons [Time frame: 6 months]
  • Supraspinatous muscle echogenicity measurement [Time frame: 6 months]
  • The assessment of the degree of fatty infiltration of the supraspinatus muscle [Time frame: 6 months]
  • The Montreal Cognitive Assessment [Time frame: 6 months]
  • The Trail Making Test [Time frame: 6 months]
  • A 3D measurement of the Supraspinatus Injury [Time frame: 6 months]
  • Ellman Classification of Partial-Thickness Rotator Cuff Tears [Time frame: 6 months]
  • Athens Insomnia Scale [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Poland · 1 center
  • Medical University of Lodz — Lodz

Identifiers

NCT: NCT06631976 · RCT-Physio-Injections-4-groups

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗