Platelet-rich Plasma Injections and Physiotherapy in the Treatment of Chronic Rotator Cuff Tendinopathy
3 other identifiers
interventional
95
1 country
1
Brief Summary
The investigators aim to investigate whether combination of PRP injection with physiotherapy program could produce superior effect than either treatment alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 12, 2017
CompletedFirst Posted
Study publicly available on registry
April 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedDecember 23, 2020
January 1, 2020
2 years
April 12, 2017
December 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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
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
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.
Study Arms (3)
PRP preparation
ACTIVE COMPARATORPRP 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 COMPARATORPhysiotherapy 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 COMPARATORPRP 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ShinKongHospital
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lin-Fen Hsieh, M.D
Shin Kong Wu Ho-Su Memorial Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2017
First Posted
April 28, 2017
Study Start
August 1, 2016
Primary Completion
July 31, 2018
Study Completion
July 31, 2018
Last Updated
December 23, 2020
Record last verified: 2020-01