Supraspinatus InjuryNCT06631976
Conservative Treatment in Patients With Supraspinatus Tendon Injury.
A study testing 1ml of Depo-Medrol® injection, Rehabilitation and Nerve block with 4ml of 2% lidocaine in people with Supraspinatus Injury and Sleep Disturbance, run by Medical University of Lodz at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Supraspinatus Injury, Sleep Disturbance
- What is being tested?
- 1ml of Depo-Medrol® injection, Rehabilitation and Nerve block with 4ml of 2% lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 4 Jun 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Lodz
Lodz, Łódź Voivodeship, 90-419
Michał Kanak, MD, +48 783340150, michal.kanak@umed.lodz.pl
Natalia Pawłuś, stud.
About this study
Official title: Comparison of Conservative Treatment Methods for Sleep Disorders, Pain, and Shoulder Function in Patients With Supraspinatus Tendon Injury.
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
- Being tested
- 1ml of Depo-Medrol® injection, Rehabilitation, Nerve block with 4ml of 2% lidocaine, Tropocells® PRP injection
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1ml of Depo-Medrol® injectionDrug
1ml of methylprednisolone acetate (40mg/ml) injection into subacromial bursa.
RehabilitationOther
Rehabilitation
Nerve block with 4ml of 2% lidocaineDrug
Nerve block with 4ml of 2% lidocaine around the suprascapular nerve
Tropocells® PRP injectionDrug
Tropocells® PRP injection. Patients will have an 11ml venous blood sample taken. After centrifugation, the obtained preparation will be administered to the patients intratendinously.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation | Active comparator | Rehabilitation Treatment - a group of patients will be treated using a standardized rehabilitation protocol. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Rehabilitation; Drug: Nerve block with 4ml of 2% lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (10)
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.
Measured: 6 months
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\'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.
Measured: 6 months
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\'s ability to perform various shoulder-related activities of daily living.
Measured: 6 months
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.
Measured: 6 months
The assessment of the degree of fatty infiltration of the supraspinatus muscle
A 3-point scale with the echogenicity of the trapezius muscle serving as reference: grade 1, isoechogenic; grade 2, mildly hyperechogenic; grade 3, markedly hyperechogenic.
Measured: 6 months
The Montreal Cognitive Assessment
The MoCA is a widely used screening tool designed to assess various cognitive domains, including attention, memory, language, visuospatial abilities, executive function, and orientation. The MoCA consists of a series of tasks and questions that evaluate different aspects of cognitive function. These include tasks such as naming a series of animals, remembering a list of words, drawing a clock face, and performing serial subtraction.
Measured: 6 months
The Trail Making Test
The Trail Making Test is a neuropsychological test of visual attention and task switching. It has two parts, in which the subject is instructed to connect a set of 25 dots as quickly as possible while maintaining accuracy.[1] The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning.
Measured: 6 months
A 3D measurement of the Supraspinatus Injury
Measurement of the size of the injury in three planes: depth, width and length.
Measured: 6 months
Ellman Classification of Partial-Thickness Rotator Cuff Tears
A scale which classifies an injury depending on the localization and size: Grade 1: Partial tear \<3mm in depth, Grade 2: Partial tear 3-6 mm in depth, depth does not exceed half the thickness of the tendon from the tubercle to the joint. Grade 3: Partial tear \>6mm in depth, depth exceeds half the thickness of the tendon from the tubercle to the joint. Full recovery will be defined as Grade 0. A: Articular sided; B: Bursal sided; C: Intratendinous
Measured: 6 months
Athens Insomnia Scale
The questionnaire consists of 8 questions designed to assess insomnia. The first five questions align with the ICD-10 criteria for diagnosing insomnia, including assessments of difficulties with sleep onset, awakening, total sleep time, and overall sleep quality. The last three questions assess the daytime consequences of insomnia, such as mood, functioning, and daytime sleepiness. Each question is rated from 0 to 3 points, corresponding to \'no problem\' or \'very serious problem,\' respectively. In total, all assessed items yield a score of 24 points. A validated Polish version of the AIS will be used in the study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start4 Jun 2024
- Primary completion1 May 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supraspinatus InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michał Kanak, MD, Study chair, Medical University of LodzMarcin Domżalski, Prof., Study chair, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631976
- Sponsor's protocol ID
- RCT-Physio-Injections-4-groups
- Status last verified
- Oct 2025
- First submitted
- 3 Oct 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided.
Publications
Pawlus N, Turkiewicz S, Lesman J, Gabryelska A, Domzalski M, Kanak M. Functional and Neurotrophic Outcomes After Physical Therapy and Injection-Based Treatments for Rotator Cuff Tendinopathy: The FORTIS Pilot Randomized Trial. Orthop J Sports Med. 2026 Aug 26;14(8):23259671261468532. doi: 10.1177/23259671261468532. eCollection 2026 Aug.
PubMed 42661896
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conservative Treatment Methods for Sleep Disorders, Pain, and Shoulder Function in Patients With Supraspinatus Tendon Injury.
- ClinicalTrials.gov ID
- NCT06631976
- Acronym / sponsor ID
- RCT-Physio-Injections-4-groups
- Conditions
- Supraspinatus Injury, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation | Active comparator | Other: RehabilitationRehabilitation Treatment - a group of patients will be treated using a standardized rehabilitation protocol. |
| Steroid | Experimental | Drug: 1ml of Depo-Medrol® injection, Other: RehabilitationRehabilitation treatment combined with a subacromial corticosteroid injection. Patients will receive 1ml of methylprednisolone acetate (40mg/ml) into the subacromial-subdeltoid bursa. |
| PRP | Experimental | Other: Rehabilitation, Drug: Tropocells® PRP injectionRehabilitation 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. |
| Nerve Block | Experimental | Other: Rehabilitation, Drug: Nerve block with 4ml of 2% lidocaineRehabilitation treatment combined with suprascapular nerve block. Patients will receive 4ml of 2% lidocaine around the suprascapular nerve. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1ml of Depo-Medrol® injection1ml of methylprednisolone acetate (40mg/ml) injection into subacromial bursa. | Drug | Steroid |
| RehabilitationRehabilitation | Other | Nerve Block, PRP, Rehabilitation, Steroid |
| Nerve block with 4ml of 2% lidocaineNerve block with 4ml of 2% lidocaine around the suprascapular nerve | Drug | Nerve Block |
| Tropocells® PRP injectionTropocells® PRP injection. Patients will have an 11ml venous blood sample taken. After centrifugation, the obtained preparation will be administered to the patients intratendinously. | Drug | PRP |
Primary outcome
Constant-Murley Score
Time frame: 6 months
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.
Numeric pain Rating Scale
Time frame: 6 months
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.
Range of motion measurements
Time frame: 6 months
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.
Strength measurements
Time frame: 6 months
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.
BDNF and proBDNF Assessment
Time frame: 6 months
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.
Pittsburgh Sleep Quality Index
Time frame: 6 months
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Derived from this study: PubMed 42661896Pawlus N, Turkiewicz S, Lesman J, Gabryelska A, Domzalski M, Kanak M. Functional and Neurotrophic Outcomes After Physical Therapy and Injection-Based Treatments for Rotator Cuff Tendinopathy: The FORTIS Pilot Randomized Trial. Orthop J Sports Med. 2026 Aug 26;14(8):23259671261468532. doi: 10.1177/23259671261468532. eCollection 2026 Aug.
- Individual participant dataSharing planned: Undecided. Undecided.
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Ultrasound and Shear Wave Elastography for Assessment of the Quality of Rotator Cuff Muscles
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michał Kanak, MD study chair
Medical University of Lodz
Marcin Domżalski, Prof. study chair
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1ml of Depo-Medrol® injection, Rehabilitation and Nerve block with 4ml of 2% lidocaine in people with Supraspinatus Injury and Sleep Disturbance, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michał Kanak, MD (178-334-0150, michal.kanak@umed.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant-Murley Score (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06631976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.