Rotator Cuff TendinosisPhase 4RCCTNCT04492748
Rotator Cuff Tendinopathy Conservative Treatment With Collagen, PRP or Both
A Phase 4 study testing Collagen and platelet rich plasma (PRP), Collagen and Platelet rich plasma (PRP) in people with Rotator Cuff Tendinosis and Rotator Cuff Tears, run by Sutherland Medical Center at 1 site in Poland.
Trial summary
The aim of the trial is comparison of the effectiveness of three methods of conservative treatment in partial thickness rotator cuff injury (PTRCI): collagen with PRP injections, PRP injections alone and collagen injections alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tendinosis, Rotator Cuff Tears
- What is being tested?
- Collagen and platelet rich plasma (PRP), Collagen and Platelet rich plasma (PRP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2020to 30 Sep 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical signs and symptoms of rotator cuff pathology
- an adult person consenting to injections
- partial thickness rotator cuff injury confirmed by ultrasound examination without coexisting severe pathologies (systemic inflammatory disease, malignancy, severe stage OA)
- no traumatic event
- no injections or any other local treatment in previous 1 month
Who cannot join
- full thickness rotator cuff injury
- acute, traumatic injuries requiring surgical treatment
- coexisting injuries of the shoulder joint requiring other intervention
- severe pathologies of the shoulder of another origin (systemic inflammatory disease, malignancy, severe stage OA)
- no consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collagen and PRP in Partial Thickness Rotator Cuff Injuries: Friends or Only Indifferent Neighbors: Randomized Controlled Trial
The aim of the trial is comparison of the effectiveness of three methods of conservative treatment in partial thickness rotator cuff injury (PTRCI): collagen with PRP injections, PRP injections alone and collagen injections alone.
Read the detailed description
BACKGROUND: Rotator cuff injury (RCI) occupy third place in the population among the musculoskeletal system pathologies (16%) after low back pain (25%) and knee pain (19%). Partial thickness RCI (PTRCI) is the sum of degenerative, overload and microtrauma processes and their incidence increases significantly with age (up to 30% over 60). One of the factors contributing to the injury is a negative collagen balance and slowed tendon metabolism in proportion to its blood supply disorders. Conservative treatment of PTRCI of degenerative origin is the first choice management, but there are no clear guidelines. External supply of collagen and PRP could potentially counteract these processes.
AIM: Comparison of the effectiveness of three treatment concepts: collagen with PRP, PRP alone, collagen alone in the treatment of PTRCI.
DESIGN: Randomized prospective trial without blinding SETTING: Open study for outpatients, single center study POPULATION: local population METHODS: Three groups of patients (each group 30 patients) with PTRCI confirmed by ultrasound (N=90). The assessment of the supraspinatus tendon (SSP) in standard position of internal rotation of the upper limb for ultrasound examination, assessment of the thickness of the RC in cross-section (mm). Each group treated by three ultrasound guided injections into the shoulder bursa every consecutive week: Group A - collagen (3 amp Collagen MD Shoulder) together with PRP (2ml); Group B - collagen alone (3 amp Collagen MD Shoulder); Group C - PRP alone. All patients were allowed to continue rehabilitation protocol. Primary control tools: NRS, QuickDash, EQ-5D-5L in control points: IA (initial assessment), 6, 12 and 24 weeks after last injection. Secondary control tools: percentage of patients where the RC continuity were preserved and percentage of patients who had ultrasonographic signs of RC regeneration (crossection width increase, improvement of echogenicity) during the observation period between W0 and 24 weeks.
- Conditions
- Rotator Cuff Tendinosis, Rotator Cuff Tears
- Being tested
- Collagen and platelet rich plasma (PRP), Collagen, Platelet rich plasma (PRP)
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen and platelet rich plasma (PRP)Combination product
Ultrasound guided injections
CollagenCombination product
Ultrasound guided injections
Platelet rich plasma (PRP)Combination product
Ultrasound guided injections
| Study group | Role | What they receive |
|---|---|---|
| Collagen and PRP injections | Experimental | Ultrasound guided injections Receives: Combination Product: Collagen and platelet rich plasma (PRP) |
| Collagen injections | Active comparator | Ultrasound guided injections Receives: Combination Product: Collagen |
| PRP injections | Active comparator | Ultrasound guided injections Receives: Combination Product: Platelet rich plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EQ-5D-5L index from baseline to 24 week
EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
Measured: Change from baseline to 24 weeks
QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 24 weeks
Range: 0 (the best outcome) - 100 (the worst outcome).
Measured: Change from baseline to 24 weeks
Secondary outcomes (10)
Pain according to Numeric Rating Scale (NRS)
0 (no pain) - 10 points (the worst possible pain)
Measured: Change from baseline to 6 weeks
Pain according to Numeric Rating Scale (NRS)
0 (no pain) - 10 points (the worst possible pain)
Measured: Change from baseline to 12 weeks
Pain according to Numeric Rating Scale (NRS)
0 (no pain) - 10 points (the worst possible pain)
Measured: Change from baseline to 24 weeks
Width of rotator cuff in ultrasound imaging
Dimensions of cross-section rotator cuff measure in milimeters.
Measured: Change from baseline to 24 weeks
Preservation of rotator cuff continuity in ultrasound imaging
Presence / Absence
Measured: Change from baseline to 24 weeks
Regenaration of rotator cuff in ultrasound imaging
Presence / Absence
Measured: 24 weeks
Change in EQ-5D-5L index from baseline to 6 week
EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
Measured: Change from baseline to 6 weeks
Change in EQ-5D-5L index from baseline to 12 week
EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
Measured: Change from baseline to 12 weeks
QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 6 weeks
Range: 0 (the best outcome) - 100 (the worst outcome).
Measured: Change from baseline to 6 weeks
QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 12 weeks
Range: 0 (the best outcome) - 100 (the worst outcome).
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Jul 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (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 Rotator Cuff TendinosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sutherland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Godek, Sutherland Medical Center
- Investigators
- Piotr Godek, PhD, Principal investigator, Sutherland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492748
- Sponsor's protocol ID
- SMC2020001
- Acronym
- RCCT
- Status last verified
- Mar 2021
- First submitted
- 20 Jul 2020
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Godek P, Szczepanowska-Wolowiec B, Golicki D. Collagen and platelet-rich plasma in partial-thickness rotator cuff injuries. Friends or only indifferent neighbours? Randomised controlled trial. BMC Musculoskelet Disord. 2022 Dec 20;23(1):1109. doi: 10.1186/s12891-022-06089-9.
PubMed 36536333
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagen and PRP in Partial Thickness Rotator Cuff Injuries: Friends or Only Indifferent Neighbors: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04492748
- Acronym / sponsor ID
- RCCT / SMC2020001
- Conditions
- Rotator Cuff Tendinosis, Rotator Cuff Tears
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sutherland Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 30 Jul 2020 (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.
The aim of the trial is comparison of the effectiveness of three methods of conservative treatment in partial thickness rotator cuff injury (PTRCI): collagen with PRP injections, PRP injections alone and collagen injections alone.
Detailed description
BACKGROUND: Rotator cuff injury (RCI) occupy third place in the population among the musculoskeletal system pathologies (16%) after low back pain (25%) and knee pain (19%). Partial thickness RCI (PTRCI) is the sum of degenerative, overload and microtrauma processes and their incidence increases significantly with age (up to 30% over 60). One of the factors contributing to the injury is a negative collagen balance and slowed tendon metabolism in proportion to its blood supply disorders. Conservative treatment of PTRCI of degenerative origin is the first choice management, but there are no clear guidelines. External supply of collagen and PRP could potentially counteract these processes.
AIM: Comparison of the effectiveness of three treatment concepts: collagen with PRP, PRP alone, collagen alone in the treatment of PTRCI.
DESIGN: Randomized prospective trial without blinding SETTING: Open study for outpatients, single center study POPULATION: local population METHODS: Three groups of patients (each group 30 patients) with PTRCI confirmed by ultrasound (N=90). The assessment of the supraspinatus tendon (SSP) in standard position of internal rotation of the upper limb for ultrasound examination, assessment of the thickness of the RC in cross-section (mm). Each group treated by three ultrasound guided injections into the shoulder bursa every consecutive week: Group A - collagen (3 amp Collagen MD Shoulder) together with PRP (2ml); Group B - collagen alone (3 amp Collagen MD Shoulder); Group C - PRP alone. All patients were allowed to continue rehabilitation protocol. Primary control tools: NRS, QuickDash, EQ-5D-5L in control points: IA (initial assessment), 6, 12 and 24 weeks after last injection. Secondary control tools: percentage of patients where the RC continuity were preserved and percentage of patients who had ultrasonographic signs of RC regeneration (crossection width increase, improvement of echogenicity) during the observation period between W0 and 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Collagen and PRP injections | Experimental | Combination Product: Collagen and platelet rich plasma (PRP)Ultrasound guided injections |
| Collagen injections | Active comparator | Combination Product: CollagenUltrasound guided injections |
| PRP injections | Active comparator | Combination Product: Platelet rich plasma (PRP)Ultrasound guided injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- clinical signs and symptoms of rotator cuff pathology
- an adult person consenting to injections
- partial thickness rotator cuff injury confirmed by ultrasound examination without coexisting severe pathologies (systemic inflammatory disease, malignancy, severe stage OA)
- no traumatic event
- no injections or any other local treatment in previous 1 month
Key exclusion criteria (5 listed)
- full thickness rotator cuff injury
- acute, traumatic injuries requiring surgical treatment
- coexisting injuries of the shoulder joint requiring other intervention
- severe pathologies of the shoulder of another origin (systemic inflammatory disease, malignancy, severe stage OA)
- no consent
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 |
|---|---|---|
| Collagen and platelet rich plasma (PRP)Ultrasound guided injections | Combination product | Collagen and PRP injections |
| CollagenUltrasound guided injections | Combination product | Collagen injections |
| Platelet rich plasma (PRP)Ultrasound guided injections | Combination product | PRP injections |
Primary outcome
Change in EQ-5D-5L index from baseline to 24 week
Time frame: Change from baseline to 24 weeks
EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome.
QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 24 weeks
Time frame: Change from baseline to 24 weeks
Range: 0 (the best outcome) - 100 (the worst outcome).
10 secondary outcomes
Pain according to Numeric Rating Scale (NRS)
Time frame: Change from baseline to 6 weeks
Pain according to Numeric Rating Scale (NRS)
Time frame: Change from baseline to 12 weeks
Pain according to Numeric Rating Scale (NRS)
Time frame: Change from baseline to 24 weeks
Width of rotator cuff in ultrasound imaging
Time frame: Change from baseline to 24 weeks
Preservation of rotator cuff continuity in ultrasound imaging
Time frame: Change from baseline to 24 weeks
Regenaration of rotator cuff in ultrasound imaging
Time frame: 24 weeks
Change in EQ-5D-5L index from baseline to 6 week
Time frame: Change from baseline to 6 weeks
Change in EQ-5D-5L index from baseline to 12 week
Time frame: Change from baseline to 12 weeks
QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 6 weeks
Time frame: Change from baseline to 6 weeks
QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 12 weeks
Time frame: Change from baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Derived from this study: PubMed 36536333Godek P, Szczepanowska-Wolowiec B, Golicki D. Collagen and platelet-rich plasma in partial-thickness rotator cuff injuries. Friends or only indifferent neighbours? Randomised controlled trial. BMC Musculoskelet Disord. 2022 Dec 20;23(1):1109. doi: 10.1186/s12891-022-06089-9.
- Individual participant dataSharing planned: No
Related trials for Rotator Cuff Tendinosis
Recruiting
Effects of Rotator Cuff Drills Versus Progressive Resistance Exercises on Chronic Rotator Cuff Tendinopathy
Rotator Cuff Tendinosis
Recruiting
Embolization Treatment of Chronic Refractory Shoulder Tendinopathy
Shoulder Pain, Tendinopathy
Recruiting
Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome - Outcomes and Mechanisms
Rotator Cuff Tendinosis, Rotator Cuff Tendinitis
Active, not recruitingPhase 4
Connective Tissue Matrix for Rotator Cuff Tendinopathy
Tendinopathy, Shoulder Pain
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. This study is not recruiting at the moment.
Piotr Godek, PhD principal investigator
Sutherland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Collagen and platelet rich plasma (PRP), Collagen and Platelet rich plasma (PRP) in people with Rotator Cuff Tendinosis and Rotator Cuff Tears, run by Sutherland Medical Center 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 5 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: status not confirmed, as of the sponsor's last update on 11 Mar 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EQ-5D-5L index from baseline to 24 week (time frame: Change from baseline to 24 weeks). The study lists 2 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 NCT04492748, 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 11 Mar 2021.