The Value of Platelet-Rich Plasma in Chronic Midportion Achilles Tendinopathy: a Double-blind Randomized Clinical Trial (PRICT)
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|ClinicalTrials.gov Identifier: NCT00761423|
Recruitment Status : Completed
First Posted : September 29, 2008
Last Update Posted : May 18, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Achilles Tendinopathy||Biological: PRP Injection with eccentric exercises Biological: Placebo Injection with eccentric exercises||Phase 4|
Introduction- Overuse injury of the Achilles tendon is a common entity in athletes and older athletes are at an increased risk. When the exact origin of tendon pain is unclear, the term tendinopathy is preferred. Most accepted treatment at this moment is an eccentric exercise programme, according to the Dutch guidelines. However, a recent systematic review on the effectiveness of eccentric exercises to treat lower extremity tendinoses concluded that it is unclear whether eccentric exercises are more effective than other forms of treatment.
Recent studies described new treatment strategies in tendinopathies, such as the use of platelet-rich plasma (PRP). Platelets can participate actively in tissue repair processes and stimulate the release of several growth factors. Recently, it was found that platelet-rich plasma clot releasate stimulates cell proliferation, collagen deposition, and enhances the gene expression of matrix degrading enzymes and endogenous growth factors by human tendon cells in vitro. The only published clinical cohort study in tendon research reported 93% reduction of pain for PRP-treated patients with chronic elbow tendinosis. Also on short term follow-up, the PRP injection was more beneficial than injection with an anaesthetic agent.
Aim- To monitor the potential clinical improvement of chronic midportion Achilles tendinopathy after injection with PRP and to evaluate the recovery process in time using a new Ultrasonographic method (Ultrasonographic Tissue Characterisation).
Hypothesis: The average VISA-A score is higher in the patient group treated with eccentric exercise therapy in combination with a PRP injection in comparison with the group treated with a saline injection in combination with eccentric exercises.
Study population- In total, 54 patients with symptomatic Achilles tendinopathy will be included in the study.
Study design- The study will be a double-blind randomised single-centre clinical trial comparing 2 treatment groups. The researcher, the sports medicine physician and the patients will be blinded to the received therapy.
Therapy- All patients will perform a heavy load eccentric exercise programme, consisting of 180 repetitions daily. The patients will be randomised into 2 treatment groups: ultrasound guided intratendinous saline injection with eccentric exercises and ultrasound guided intratendinous PRP injection with eccentric exercises.
Follow-up- Follow-up (clinically and ultrasonographically) will be at 6, 12, 24 and 52 weeks. At 24 weeks, the researcher will be unblinded after the analysis of the preliminary data. The patients will remain blinded to the therapy until 52 weeks follow-up. At 52 weeks follow-up a second, blinded researcher will evaluate the patients using the primary and secondary outcome measurements.
Outcome measurements- Primary outcome measurement: VISA-A score, a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy. As secondary outcome measurements subjective patient satisfaction and return to sports will be rated. For the evaluation of tendon repair, Ultrasonographic Tissue Characterization (UTC) and Power Doppler ultrasound (PDU) will be performed. UTC was previously developed in horse tendons and provides quantitative information on tendon fiber alignment and the related ultra-structural integrity of the tendon tissue through a non-invasive approach.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Value of Platelet-Rich Plasma in Chronic Midportion Achilles Tendinopathy: a Double-blind Randomized Clinical Trial|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||August 2009|
Combination of eccentric exercises and injection of PRP
Biological: PRP Injection with eccentric exercises
PRP Injection with eccentric exercises
Placebo Comparator: 2
Combination of eccentric exercises and physiological saline injection
Biological: Placebo Injection with eccentric exercises
Placebo Injection with eccentric exercises
- VISA-A Score [ Time Frame: 6, 12, 24 and 52 weeks ]
- Ultrasonographic Tissue Characterization [ Time Frame: 6,12, 24 and 52 weeks ]
- Complications [ Time Frame: Anytime ]
- Power doppler sound [ Time Frame: 6, 12, 24 and 52 weeks ]
- Patient satisfaction [ Time Frame: 6, 12, 24 and 52 weeks ]
- Return to sport [ Time Frame: 6, 12, 24 and 52 weeks ]
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Clinical diagnosis "chronic midportion Achilles tendinopathy"
- Age 18-70 years
- Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum)
- Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and palpabel "gap")
- Clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes are plantar flexed against resistance)
- Clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural nerve)
- Clinical suspicion of peroneal subluxation (visible luxation of the mm. Peroneï spot in combination with localized pain)
- Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid Arthritis and sarcoidosis.
- Condition that prevents the patients from executing an active exercise programme
- Patient has already performed eccentric exercises, according to the schedule of Alfredson et al (12 weeks)
- Patient has already received an injection of PRP for this injury
- Patient does not wish, for whatever reason, to undergo one of the two treatments
- Known presence of a pregnancy
- Condition of the Achilles tendon caused by medications (arising in relation to moment of intake), such as quinolones and statins
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761423
|Erasmus Medical Center|
|Principal Investigator:||RJ De Vos, MD||Erasmus Medical Center|
|Responsible Party:||Zimmer Biomet|
|Other Study ID Numbers:||
BMET NL 02
|First Posted:||September 29, 2008 Key Record Dates|
|Last Update Posted:||May 18, 2017|
|Last Verified:||May 2017|
Wounds and Injuries