Conservative Treatment in Patients With Supraspinatus Tendon Injury.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorMedical University of Lodz

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Other accompanying pain symptoms.

History of shoulder surgery.

Coexistence of psychiatric or neurological disorders.

Presence of comorbidities that may disrupt sleep.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 1ml of Depo-Medrol® injection

    Drug

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

  • Rehabilitation

    Other intervention

    Rehabilitation

  • Nerve block with 4ml of 2% lidocaine

    Drug

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

  • 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.

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: RehabilitationActive comparator 1 intervention
Group B: SteroidExperimental treatment 2 interventions
Group C: PRPExperimental treatment 2 interventions
Group D: Nerve BlockExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
6 months
3

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.

Time frame
6 months
4

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.

Time frame
6 months

Secondary outcomes

1

The Laitinen Pain Scale

The Laitinen Pain Scale, also known as the Laitinen Analogue Scale, is a pain assessment tool used in clinical settings to measure pain intensity. The questionnaire provides a quantitative measure of pain intensity, allowing healthcare providers to track changes in pain over time and assess the effectiveness of pain management interventions. It also facilitates communication between patients and clinicians, enabling more accurate pain assessment and tailored treatment plans.

Time frame
6 months
2

The Simple Shoulder Test

The SST is a clinical assessment tool used to evaluate shoulder function and disability. The SST consists of 12 questions that assess the patient\&#39;s ability to perform various shoulder-related activities of daily living. These activities include reaching overhead, reaching behind the back, and lifting objects. Each question is scored on a dichotomous scale (yes/no), with a score of 1 assigned for each activity the patient can perform without difficulty.

Time frame
6 months
3

The American Shoulder and Elbow Surgeons

The ASES is a widely used clinical assessment tool designed to evaluate shoulder function and assess outcomes following treatment for various shoulder conditions. The ASES Shoulder Score comprises two main components: pain and function. The function component evaluates the patient\&#39;s ability to perform various shoulder-related activities of daily living.

Time frame
6 months
4

Supraspinatous muscle echogenicity measurement

The echogenicity of supraspinatus muscle and trapezius muscle will be determined using ImageJ software (National Institutes of Health, U.S.; https://imagej.nih.gov/ij/). The echogenicity ratio of supraspinatus/trapezius muscle will be calculated.

Time frame
6 months

Other outcomes

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