Rotator Cuff TearPhase 1NCT03548662
The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear
A Phase 1 study testing Platelet-Rich Plasma, Hyaluronic Acid and Exercise in people with Rotator Cuff Tear, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This study aims to evaluate the effect of platelet rich plasma combined with exercise therapy for patients with partial thickness rotator cuff tears. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Platelet-Rich Plasma, Hyaluronic Acid and Exercise
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Mar 2014to 6 Feb 2018
- Phase
- Phase 1
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 85 years old, without significant cognition impairment (MMSE>20)
- Shoulder pain score(NRS)> 5
- Partial tear of supraspinatus tendon, proved by ultrasonography or MRI
- Patients who signed informed consent
- Patients who agreed to stop using analgesics during the experimental period
Who cannot join
- Thrombocytopenia (platelets less than 15000 per microliter)
- Patient who is using anticoagulant or has history of coagulation dysfunction
- Uncontrolled infection
- End stage malignant disease
- Infection or other skin condition over injection site
- History of shoulder or humeral fracture, dislocation or operation
- Psychiatric problems that precludes informed consent or inability to read or write
- Other serious problems that preclude participation of the study
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the effect of platelet rich plasma combined with exercise therapy for patients with partial thickness rotator cuff tears.
Read the detailed description
The purpose of this study is to exam the outcome of rotator cuff tear patients who received platelet rich plasma injection followed by rehabilitative exercise. The specific aim of this study is to determine the outcomes of treatment of partial thickness rotator cuff tears with platelet rich plasma (PRP) and rehabilitative exercise. Subjects with partial thickness rotator cuff tears will be designated to receive an injection of PRP or hyaluronic acid, followed by rehabilitative exercise. Shoulder function and tendon healing will be evaluated using the patient surveys as well as ultrasound. Subjects will be followed for 3 months to determine the outcomes of the treatment.
The hypothesis is that there is no difference in healing rate or functional outcomes in patients treated with PRP injections plus rehabilitative exercise compared with hyaluronic acid injection plus rehabilitative exercise for the treatment of partial thickness rotator cuff tears.
- Conditions
- Rotator Cuff Tear
- Being tested
- Platelet-Rich Plasma, Hyaluronic Acid, Exercise
- Keywords
- Rotator Cuff Tear, Platelet Rich Plasma, Ultrasound, Exercise, Hyaluronic Acid
- Medical subject headings
- Rotator Cuff Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich PlasmaBiological
Also called RegenKit® PRP
Platelet-Rich Plasma prepared by RegenKit® PRP, Regenlab SA
Hyaluronic AcidDrug
Also called Hyruan Plus Inj.
Hyruan Plus Inj. produced by LG Life Sciences, Ltd.
ExerciseOther
passive range of motion (PROM) exercise, active-assisted range of motion (AAROM) exercise, active range of motion (AROM) exercise, rotator cuff strengthening exercise, and peri-scapular muscle strengthening exercise
| Study group | Role | What they receive |
|---|---|---|
| Platelet-Rich Plasma Protein (PRP) Group | Experimental | Subjects in this group will receive PRP injection into tear site, followed by rehabilitative exercise Receives: Biological: Platelet-Rich Plasma; Other: Exercise |
| Hyaluronic Acid Group | Active comparator | Subjects in this group will receive one injection with hyaluronic acid followed by rehabilitative exercise Receives: Drug: Hyaluronic Acid; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-Murley shoulder score
The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100.
Measured: Change is measured from baseline to 1.5 and 3 months
Secondary outcomes (4)
Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NRS) is a 11-point numeric scale ranges from '0' representing no pain to '10' representing worst pain imaginable
Measured: Change is measured from baseline to 1.5 and 3 months
Shoulder range of motion
The shoulder range of motion (ROM) is measured in both active and passive manner and in four direction including flexion, extension, internal rotation and external rotation.
Measured: Change is measured from baseline to 1.5 and 3 months
Shoulder Pain and Disability Index (SPADI)
SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability. The scores from both domains are averaged to derive a total score with 0 being the best outcome (less disability) and 100 the worst (greater disability).
Measured: Change is measured from baseline to 1.5 and 3 months
Size of rotator cuff tear
Rotator cuff tear size will be determined using ultrasound imaging. The image will be conducted in sagittal plan, transverse plan and will measure the maximal size of tear.
Measured: Change is measured from baseline to 1.5 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start4 Mar 2014
- Primary completion6 Feb 2018
- Study completion6 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jia chi Wang, MD, Principal investigator, Taipei Veteran General hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548662
- Sponsor's protocol ID
- 2014-02-005B
- Status last verified
- Jun 2018
- First submitted
- 10 Oct 2017
- Last updated
- 7 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platelet Rich Plasma Injection Combined With Exercise Rehabilitation in Patients With Rotator Cuff Tear
- ClinicalTrials.gov ID
- NCT03548662
- Acronym / sponsor ID
- 2014-02-005B
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator Cuff Tear, Platelet Rich Plasma, Ultrasound, Exercise, Hyaluronic Acid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 4 Mar 2014 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 7 Jun 2018 (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.
This study aims to evaluate the effect of platelet rich plasma combined with exercise therapy for patients with partial thickness rotator cuff tears.
Detailed description
The purpose of this study is to exam the outcome of rotator cuff tear patients who received platelet rich plasma injection followed by rehabilitative exercise. The specific aim of this study is to determine the outcomes of treatment of partial thickness rotator cuff tears with platelet rich plasma (PRP) and rehabilitative exercise. Subjects with partial thickness rotator cuff tears will be designated to receive an injection of PRP or hyaluronic acid, followed by rehabilitative exercise. Shoulder function and tendon healing will be evaluated using the patient surveys as well as ultrasound. Subjects will be followed for 3 months to determine the outcomes of the treatment.
The hypothesis is that there is no difference in healing rate or functional outcomes in patients treated with PRP injections plus rehabilitative exercise compared with hyaluronic acid injection plus rehabilitative exercise for the treatment of partial thickness rotator cuff tears.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Plasma Protein (PRP) Group | Experimental | Biological: Platelet-Rich Plasma, Other: ExerciseSubjects in this group will receive PRP injection into tear site, followed by rehabilitative exercise |
| Hyaluronic Acid Group | Active comparator | Drug: Hyaluronic Acid, Other: ExerciseSubjects in this group will receive one injection with hyaluronic acid followed by rehabilitative exercise |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 40 and 85 years old, without significant cognition impairment (MMSE>20)
- Shoulder pain score(NRS)> 5
- Partial tear of supraspinatus tendon, proved by ultrasonography or MRI
- Patients who signed informed consent
- Patients who agreed to stop using analgesics during the experimental period
Key exclusion criteria (8 listed)
- Thrombocytopenia (platelets less than 15000 per microliter)
- Patient who is using anticoagulant or has history of coagulation dysfunction
- Uncontrolled infection
- End stage malignant disease
- Infection or other skin condition over injection site
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 |
|---|---|---|
| Platelet-Rich PlasmaAlso: RegenKit® PRPPlatelet-Rich Plasma prepared by RegenKit® PRP, Regenlab SA | Biological | Platelet-Rich Plasma Protein (PRP) Group |
| Hyaluronic AcidAlso: Hyruan Plus Inj.Hyruan Plus Inj. produced by LG Life Sciences, Ltd. | Drug | Hyaluronic Acid Group |
| Exercisepassive range of motion (PROM) exercise, active-assisted range of motion (AAROM) exercise, active range of motion (AROM) exercise, rotator cuff strengthening exercise, and peri-scapular muscle strengthening exercise | Other | Hyaluronic Acid Group, Platelet-Rich Plasma Protein (PRP) Group |
Primary outcome
Constant-Murley shoulder score
Time frame: Change is measured from baseline to 1.5 and 3 months
The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100.
4 secondary outcomes
Numeric Pain Rating Scale
Time frame: Change is measured from baseline to 1.5 and 3 months
Shoulder range of motion
Time frame: Change is measured from baseline to 1.5 and 3 months
Shoulder Pain and Disability Index (SPADI)
Time frame: Change is measured from baseline to 1.5 and 3 months
Size of rotator cuff tear
Time frame: Change is measured from baseline to 1.5 and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
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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. This study is not recruiting at the moment.
Jia chi Wang, MD principal investigator
Taipei Veteran General hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Platelet-Rich Plasma, Hyaluronic Acid and Exercise in people with Rotator Cuff Tear, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 7 Jun 2018. 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 Taiwan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Constant-Murley shoulder score (time frame: Change is measured from baseline to 1.5 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2018.