PRP Injection OnlyNCT03133416
Platelet-rich Plasma Injections and Physiotherapy in the Treatment of Chronic Rotator Cuff Tendinopathy
A study testing PRP preparation, Physiotherapy and PRP and physiotherapy in people with PRP Injection Only and Physiotherapy Only, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
The investigators aim to investigate whether combination of PRP injection with physiotherapy program could produce superior effect than either treatment alone. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- PRP Injection Only, Physiotherapy Only, PRP and Physiotherapy
- What is being tested?
- PRP preparation, Physiotherapy and PRP and physiotherapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2016to 31 Jul 2018
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic rotator cuff tendinopathy, including small (<1cm) rotator cuff tear (partial or full-thickness), proven by ultrasound.
- Duration of symptom longer than 1 month.
- Aged ≥20 years old.
Who cannot join
- Fracture, dislocation, or arthritis of the shoulder,
- Previous shoulder joint surgery,
- Rotator cuff tear with size ≥ 1cm,
- Calcification of rotator cuff tendons,
- Severe medical comorbidities, e.g., malignant neoplasms, blood dyscrasia, and serious infection, etc.,
- Pregnancy,
- Cognitive impairment (Mini-Mental Status Examination < 24),
- Hypersensitive to thrombin.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to investigate whether combination of PRP injection with physiotherapy program could produce superior effect than either treatment alone.
Read the detailed description
Rotator cuff (RC) tears are a common source of shoulder pain and account for more than 4.5 million physician visits per year. In the overall population, the prevalence of RC tear is 20.7% and rises to 50% among patients older than 80 years. Partial-thickness and full-thickness RC tears has also been reported in 30% to 50% of the population aged older than 50 years. RC tears cause shoulder dysfunction, interfere daily activity, and may reduce quality of life. Treatment of RC tear includes surgical and conservative treatment. Considering operative risk, high possibility of re-tear after operation, and possible tendon healing with non-surgical treatment, for patients with a partial-thickness tear or a small full-thickness tear, conservative treatment is usually tried first. Previous report found that conservative treatment might be effective in 73% to 80% of cases with full-thickness tear of the rotator cuff. Conservative treatment of RC tear consists of rest, physiotherapy (including therapeutic exercise), non-steroidal anti-inflammatory drugs, and corticosteroid or hyaluronate subacromial injections. A. In addition, exercise has also been proven effective in the management of RC tear. In spite of the advanced surgical techniques and conservative methods, healing of RC tear remains problematic due to poor vascularization at the lesion site and failure to restore normal enthesis (tendon-bone junction) histology. Over past few years platelet-rich plasma (PRP) presents an attractive option to improve and accelerate healing of the rotator cuff lesion. PRP is defined as a portion of the plasma fraction of autologous blood having a platelet concentration above baseline (usually 2X to 4X). It is derived from centrifuging whole blood, and contains numerous growth factors, including platelet-derived growth factor, vascular endothelial growth factor, transforming growth factor, fibroblast growth factor, epidermal growth factor, hepatocyte growth factor, and insulin-like growth factor. Because of the increased concentration and release of growth factors, PRP can potentially enhance the recruitment and proliferation of tenocytes, stem cells, and endothelial cells. Given the autologous nature of PRP, safety concerns are minimal. Relative contraindications include patients with a history of thrombocytopenia, use of anticoagulants, tumor, metastatic disease, active infection, or pregnancy. Up to now no documented cases of carcinogenesis or tumor growth associated with the use of PRP has been reported. Previous studies showed using autologous leukocyte- and platelet-rich fibrin could increase vascularization during early healing of chronic rotator cuff tear, and that ultrasound-guided PRP injection is superior to dry needling in patients with supraspinatus tendon lesion. However, in a 1-yr randomized controlled trial with combination of 6 week physiotherapy program, PRP injection did not produce extra effect than placebo injection. Because controversy exists with regard to the effect of PRP injection, the investigators aim to investigate whether combination of PRP injection with physiotherapy program could produce superior effect than either treatment alone.
- Being tested
- PRP preparation, Physiotherapy, PRP and physiotherapy
- Keywords
- rotator cuff tendinopathy, rotator cuff tear, platelet-rich plasma, physiotherapy, exercise
- 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.
PRP preparationOther
PhysiotherapyDevice
PRP and physiotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| PRP preparation | Active comparator | PRP will be prepared by taking 10ml venous blood which is then mixed with 2ml of thrombin and centrifuged in a specially designed tube at 3400 rotations per minute (rpm) for 15 minutes. Then about 2ml PRP will be extracted, and will be infiltrated to the lesion site under ultrasound guidance. The injection technique is similar to that described by Kesikburun .21 Patients in group 1 or group 3 will receive 2 injections of PRP, with 1 month interval. Receives: Other: PRP preparation |
| Physiotherapy | Active comparator | Physiotherapy includes hot pack, electric therapy and therapeutic exercise, which will be supervised by a senior physical therapist. The therapeutic exercise consists of active and passive stretch, and strengthening exercise of the rotator cuff, the shoulder girdle, and the pectoral muscles, 3 times a week, and will continue for 1.5 months. After 1.5 months' supervised training, home program exercise follows and will be continued for another 1.5 months. Receives: Device: Physiotherapy |
| PRP and physiotherapy | Active comparator | PRP will be prepared by taking 10ml venous blood which is then mixed with 2ml of thrombin and centrifuged in a specially designed tube at 3400 rotations per minute (rpm) for 15 minutes. Then about 2ml PRP will be extracted, and will be infiltrated to the lesion site under ultrasound guidance. The injection technique is similar to that described by Kesikburun .21 Patients in group 1 or group 3 will receive 2 injections of PRP, with 1 month interval;Physiotherapy includes hot pack, electric therapy and therapeutic exercise, which will be supervised by a senior physical therapist. The therapeutic exercise consists of active and passive stretch, and strengthening exercise of the rotator cuff, the shoulder girdle, and the pectoral muscles, 3 times a week, and will continue for 1.5 months. After 1.5 months' supervised training, home program exercise follows and will be continued for another 1.5 months. Receives: Other: PRP and physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the VAS for pain
The VAS pain scores during Neer test will be obtained using a horizontal lines of 100 mm, with 0 on the left indicating no pain and 100 on the right indicating very severe pain. A VAS has been shown to be reliable and sensitive for quantifying pain, with test-retest reliability of >0.90.28 In previous studies of patients treated for various shoulder disorders, the responsiveness of VAS for pain was moderate to good.
Measured: Clinical evaluation will be conducted at pre-treatment, post-treatment 1.5 months and post-treatment 3 months and post-treatment 6 months after treatments.
Secondary outcomes (3)
the active ROM
The maximal active ROMs of the affected shoulder will be measured using a goniometer under the guidelines of the American Academy of Orthopedic Surgeons. These measurements included abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0 degrees of abduction.
Measured: Clinical evaluation will be conducted at pre-treatment, post-treatment 1.5 months and post-treatment 3 months and post-treatment 6 months after treatments.
SPADI
The SPADI is a self-administered questionnaire to assess the pain and disability associated with shoulder diseases. It consists of 13 items being divided into 2 subclasses, 5 items for pain and 8 items for disabilities. The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses.
Measured: Clinical evaluation will be conducted at pre-treatment, post-treatment 1.5 months and post-treatment 3 months and post-treatment 6 months after treatments.
SF-36
The SF-36 is a 36-item questionnaire that evaluates the quality of life . It is composed of eight subscales: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. Each subscale has a score range of 0-100, with a higher score indicating better health status.
Measured: Clinical evaluation will be conducted at pre-treatment, post-treatment 1.5 months and post-treatment 3 months and post-treatment 6 months after treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Aug 2016
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PRP Injection OnlyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Lin-Fen Hsieh, M.D, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133416
- Sponsor's protocol ID
- 20160105R
- Other IDs
- MOST 105-2314-B-341-003 -, MOST 106-2314-B-341-006 -
- Status last verified
- Jan 2020
- First submitted
- 12 Apr 2017
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-rich Plasma Injections and Physiotherapy in the Treatment of Chronic Rotator Cuff Tendinopathy
- ClinicalTrials.gov ID
- NCT03133416
- Acronym / sponsor ID
- 20160105R
- Keywords
- rotator cuff tendinopathy, rotator cuff tear, platelet-rich plasma, physiotherapy, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 28 Apr 2017 (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 investigators aim to investigate whether combination of PRP injection with physiotherapy program could produce superior effect than either treatment alone.
Detailed description
Rotator cuff (RC) tears are a common source of shoulder pain and account for more than 4.5 million physician visits per year. In the overall population, the prevalence of RC tear is 20.7% and rises to 50% among patients older than 80 years. Partial-thickness and full-thickness RC tears has also been reported in 30% to 50% of the population aged older than 50 years. RC tears cause shoulder dysfunction, interfere daily activity, and may reduce quality of life. Treatment of RC tear includes surgical and conservative treatment. Considering operative risk, high possibility of re-tear after operation, and possible tendon healing with non-surgical treatment, for patients with a partial-thickness tear or a small full-thickness tear, conservative treatment is usually tried first. Previous report found that conservative treatment might be effective in 73% to 80% of cases with full-thickness tear of the rotator cuff. Conservative treatment of RC tear consists of rest, physiotherapy (including therapeutic exercise), non-steroidal anti-inflammatory drugs, and corticosteroid or hyaluronate subacromial injections. A. In addition, exercise has also been proven effective in the management of RC tear. In spite of the advanced surgical techniques and conservative methods, healing of RC tear remains problematic due to poor vascularization at the lesion site and failure to restore normal enthesis (tendon-bone junction) histology. Over past few years platelet-rich plasma (PRP) presents an attractive option to improve and accelerate healing of the rotator cuff lesion. PRP is defined as a portion of the plasma fraction of autologous blood having a platelet concentration above baseline (usually 2X to 4X). It is derived from centrifuging whole blood, and contains numerous growth factors, including platelet-derived growth factor, vascular endothelial growth factor, transforming growth factor, fibroblast growth factor, epidermal growth factor, hepatocyte growth factor, and insulin-like growth factor. Because of the increased concentration and release of growth factors, PRP can potentially enhance the recruitment and proliferation of tenocytes, stem cells, and endothelial cells. Given the autologous nature of PRP, safety concerns are minimal. Relative contraindications include patients with a history of thrombocytopenia, use of anticoagulants, tumor, metastatic disease, active infection, or pregnancy. Up to now no documented cases of carcinogenesis or tumor growth associated with the use of PRP has been reported. Previous studies showed using autologous leukocyte- and platelet-rich fibrin could increase vascularization during early healing of chronic rotator cuff tear, and that ultrasound-guided PRP injection is superior to dry needling in patients with supraspinatus tendon lesion. However, in a 1-yr randomized controlled trial with combination of 6 week physiotherapy program, PRP injection did not produce extra effect than placebo injection. Because controversy exists with regard to the effect of PRP injection, the investigators aim to investigate whether combination of PRP injection with physiotherapy program could produce superior effect than either treatment alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRP preparation | Active comparator | Other: PRP preparationPRP will be prepared by taking 10ml venous blood which is then mixed with 2ml of thrombin and centrifuged in a specially designed tube at 3400 rotations per minute (rpm) for 15 minutes. Then about 2ml PRP will be extracted, and will be infiltrated to the lesion site under ultrasound guidance. The injection technique is similar to that described by Kesikburun .21 Patients in group 1 or group 3 will receive 2 injections of PRP, with 1 month interval. |
| Physiotherapy | Active comparator | Device: PhysiotherapyPhysiotherapy includes hot pack, electric therapy and therapeutic exercise, which will be supervised by a senior physical therapist. The therapeutic exercise consists of active and passive stretch, and strengthening exercise of the rotator cuff, the shoulder girdle, and the pectoral muscles, 3 times a week, and will continue for 1.5 months. After 1.5 months' supervised training, home program exercise follows and will be continued for another 1.5 months. |
| PRP and physiotherapy | Active comparator | Other: PRP and physiotherapyPRP will be prepared by taking 10ml venous blood which is then mixed with 2ml of thrombin and centrifuged in a specially designed tube at 3400 rotations per minute (rpm) for 15 minutes. Then about 2ml PRP will be extracted, and will be infiltrated to the lesion site under ultrasound guidance. The injection technique is similar to that described by Kesikburun .21 Patients in group 1 or group 3 will receive 2 injections of PRP, with 1 month interval;Physiotherapy includes hot pack, electric therapy and therapeutic exercise, which will be supervised by a senior physical therapist. The therapeutic exercise consists of active and passive stretch, and strengthening exercise of the rotator cuff, the shoulder girdle, and the pectoral muscles, 3 times a week, and will continue for 1.5 months. After 1.5 months' supervised training, home program exercise follows and will be continued for another 1.5 months. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic rotator cuff tendinopathy, including small (<1cm) rotator cuff tear (partial or full-thickness), proven by ultrasound.
- Duration of symptom longer than 1 month.
- Aged ≥20 years old.
Key exclusion criteria (8 listed)
- Fracture, dislocation, or arthritis of the shoulder,
- Previous shoulder joint surgery,
- Rotator cuff tear with size ≥ 1cm,
- Calcification of rotator cuff tendons,
- Severe medical comorbidities, e.g., malignant neoplasms, blood dyscrasia, and serious infection, etc.,
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 |
|---|---|---|
| PRP preparation | Other | PRP preparation |
| Physiotherapy | Device | Physiotherapy |
| PRP and physiotherapy | Other | PRP and physiotherapy |
Primary outcome
Change of the VAS for pain
Time frame: Clinical evaluation will be conducted at pre-treatment, post-treatment 1.5 months and post-treatment 3 months and post-treatment 6 months after treatments.
The VAS pain scores during Neer test will be obtained using a horizontal lines of 100 mm, with 0 on the left indicating no pain and 100 on the right indicating very severe pain. A VAS has been shown to be reliable and sensitive for quantifying pain, with test-retest reliability of >0.90.28 In previous studies of patients treated for various shoulder disorders, the responsiveness of VAS for pain was moderate to good.
3 secondary outcomes
the active ROM
Time frame: Clinical evaluation will be conducted at pre-treatment, post-treatment 1.5 months and post-treatment 3 months and post-treatment 6 months after treatments.
SPADI
Time frame: Clinical evaluation will be conducted at pre-treatment, post-treatment 1.5 months and post-treatment 3 months and post-treatment 6 months after treatments.
SF-36
Time frame: Clinical evaluation will be conducted at pre-treatment, post-treatment 1.5 months and post-treatment 3 months and post-treatment 6 months after treatments.
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 23 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
Lin-Fen Hsieh, M.D principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP preparation, Physiotherapy and PRP and physiotherapy in people with PRP Injection Only and Physiotherapy Only, run by Shin Kong Wu Ho-Su Memorial Hospital 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 3 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 23 Dec 2020. 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.
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?
Change of the VAS for pain (time frame: Clinical evaluation will be conducted at pre-treatment, post-treatment 1.5 months and post-treatment 3 months and post-treatment 6 months after treatments.). 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 23 Dec 2020.