Conservative Treatment in Patients With Supraspinatus Tendon Injury.

NCT06631976 | Recruiting

• 1 other identifier: RCT-Physio-Injections-4-groups
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Supraspinatus Injury; Sleep Disturbance

Outcome Measures

Primary Outcomes (6)

• Constant-Murley Score

  The CMS is a widely used clinical assessment tool in orthopedics, specifically for evaluating shoulder function and outcomes following shoulder surgery or injury. The CMS comprises a set of objective and subjective measures to assess various aspects of shoulder function, including pain, range of motion, strength, and activities of daily living. These components are evaluated through a combination of patient-reported outcomes and physical examination by a healthcare professional.

  6 months

• Numeric pain Rating Scale

  The NRS is a commonly used tool in clinical studies to assess pain intensity. It involves asking the patient to rate their pain on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain.

  6 months

• Range of motion measurements

  The assessment of the range of motion of the upper limb (shoulder) is a standard procedure used to evaluate the function and mobility of the shoulder joint. This assessment involves examining the range of motion in various directions, including flexion, extension, abduction, adduction, external rotation, and internal rotation.

  6 months

• Strength measurements

  The assessment of upper limb muscle strength using a dynamometer is a standard procedure used to measure the force exerted by the muscles of the shoulder and arm. This assessment involves using a handheld dynamometer to quantify the maximum force produced during specific muscle actions. Muscle strength measurement will be conducted during movements of flexion, extension, and external and internal rotation with the arm adducted and abducted.

  6 months

• BDNF and proBDNF Assessment

  BDNF belongs to a family of proteins called neurotrophins, which act through tyrosine kinase receptors, influencing nerve cells. They exert a neuroprotective effect by stimulating neurogenesis and neuroplasticity processes. In the context of sleep disorders, BDNF may influence the structural stability of neurons in brain areas related to sleep regulation, such as the hippocampus or prefrontal cortex. Disruptions in the balance of this protein may contribute to various sleep disorders. Increased expression of this protein may also contribute to disturbances in normal neuronal processes.

  6 months

• Pittsburgh Sleep Quality Index

  The PSQI is a self-assessment questionnaire that evaluates seven different aspects of sleep in adults. It assesses parameters of sleep quality such as difficulty with falling asleep, problems with maintaining sleep continuity, daytime functioning, and questions regarding the most common causes of sleep disturbances in the past four weeks. All of these contribute to a score rated from 0 to 21 points. Scores higher than 5 points indicate low sleep quality and differentiate patients into \'poor\' and \'good\' sleepers. A validated Polish version of the PSQI will be utilized in the study.

  6 months

Secondary Outcomes (10)

• The Laitinen Pain Scale

  6 months

• The Simple Shoulder Test

  6 months

• The American Shoulder and Elbow Surgeons

  6 months

• Supraspinatous muscle echogenicity measurement

  6 months

• The assessment of the degree of fatty infiltration of the supraspinatus muscle

  6 months

Study Arms (4)

Rehabilitation

ACTIVE COMPARATOR

Rehabilitation Treatment - a group of patients will be treated using a standardized rehabilitation protocol.

Other: Rehabilitation

Steroid

EXPERIMENTAL

Rehabilitation treatment combined with a subacromial corticosteroid injection. Patients will receive 1ml of methylprednisolone acetate (40mg/ml) into the subacromial-subdeltoid bursa.

Drug: 1ml of Depo-Medrol® injection; Other: Rehabilitation

PRP

EXPERIMENTAL

Rehabilitation treatment combined with PRP injection. Patients will have an 11ml venous blood sample taken. After centrifugation, the obtained preparation will be administered to the patients intratendinously.

Other: Rehabilitation; Drug: Tropocells® PRP injection

Nerve Block

EXPERIMENTAL

Rehabilitation treatment combined with suprascapular nerve block. Patients will receive 4ml of 2% lidocaine around the suprascapular nerve.

Other: Rehabilitation; Drug: Nerve block with 4ml of 2% lidocaine

Interventions

1ml of Depo-Medrol® injection DRUG

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

Steroid

Rehabilitation OTHER

Rehabilitation

Nerve Block; PRP; Rehabilitation; Steroid

Nerve block with 4ml of 2% lidocaine DRUG

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

Nerve Block

Tropocells® PRP injection DRUG

Tropocells® PRP injection. Patients will have an 11ml venous blood sample taken. After centrifugation, the obtained preparation will be administered to the patients intratendinously.

PRP

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Medical University of Lodz

Lodz, Łódź Voivodeship, 90-419, Poland

RECRUITING

MeSH Terms

Conditions

Parasomnias

Interventions

Methylprednisolone Acetate; Rehabilitation; Nerve Block; Lidocaine

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Michał Kanak, MD

  Medical University of Lodz

  STUDY CHAIR

• Marcin Domżalski, Prof.

  Medical University of Lodz

  STUDY CHAIR

Central Study Contacts

Michał Kanak, MD

CONTACT

178-334-0150; michal.kanak@umed.lodz.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: June 4, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-10

Locations

PL (1)