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Platelet-Rich Plasma Injection in Chronic Tendinopathy

The value of Platelet-rich Plasma injection in chronic midportion Achilles tendinopathy: a randomized double-blind study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25992
Enrollment
54
Registered
2008-08-25
Start date
2008-08-28
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Midportion Achilles tendinopathy, Platelet-Rich Plasma (PRP)

Interventions

In this double-blind, prospective randomized clinical single-center study two conservative treatments for Achilles tendinopathy are compared: 1. Combination of eccentric exercises and injection of P

Sponsors

The study is prepared at the Erasmus Medical Centre Rotterdam and will be performed at the Hague Medical Centre Antoniushove Leidschendam (departement of Sports Medicine)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis "chronic midportion Achilles tendinopathy" 2. Age 18-70 years

Exclusion criteria

Exclusion criteria: 1. Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum) 2. Clinical suspicion of an Achilles tendon rupture (Thompson test abnormal and palpabel "gap") 3. Clinical suspicion of plantar flexor tenosynovitis (posteromedial pain when the toes are plantar flexed against resistance) 4. Clinical suspicion of n.suralis pathology (sensitive disorder in the area of the sural nerve) 5. Clinical suspicion of peroneal subluxation (visible luxation of the mm. Peroneï spot in combination with localized pain) 6. Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid Arthritis and sarcoidosis. 7. Condition that prevents the patients from executing an active exercise programme 8. Patient has already performed eccentric exercises, according to the schedule of Alfredson et al (12 weeks) 9. Patient has already received an injection of PRP for this injury 10. Patient does not wish, for whatever reason, to undergo one of the two treatments 11. Known presence of a pregnancy 12. Condition of the Achilles tendon caused by medications (arising in relation to moment of intake), such as quinolones and statins

Design outcomes

Primary

MeasureTime frame
- VISA-A (Victorian Institute of Sport Assessment-Achilles) questionnaire: this is a validated instrument specifically designed to evaluate the severity of symptoms (pain and function) in patients with Achilles tendinopathy

Secondary

MeasureTime frame
1. Ultrasonographic Tissue Characterization (UTC): The UTC method is primarily designed for evaluating equine tendons, where “real-time” consecutive transverse ultrasound images are stored on a computer. Thereafter, the tendon can be evaluated in 3 "planes of view" and the stability of the ultrasound pattern can be quantified. Using in vitro studies of isolated equine tendons, it was demonstrated that stability of the ultrasound pattern is highly indicative for the (ultra) structural integrity of the tendon tissue. Various histopathological stages (7 tissues) could be discriminated with a high significance. In the Erasmus Medical Centre, a study is already set up to determine the value of UTC during follow-up of patients with Achilles tendinopathy who are performing eccentric exercises. An effective tool for the diagnosis and management of tendon injuries could contribute to the development of new or improved capabilities in the field of early diagnosis, prevention and in particular the therapeutic area. Measurements made by the UTC that are carried out: 1. Maximum AP diameter 2. Distance of the lesion from insertion 3. Lesion type (I-IV) 4. Percentage intact collagen bundles. At the very short term, the reference values of UTC will be collected. Therefore, this method may not yet be defined as a validated diagnostic in human tendons. 2. Power Doppler ultrasound (PDU): using PDU, the thickness of the Achilles tendon and the degree of neovascularisation (Grade 0-4 +) can be determined. 3. Subjective patient satisfaction: the patient satisfaction will be determined by the patient to ask how satisfied they are with the effect of the treatment in 4 possible categories: excellent / good / moderate / poor. The groups "excellent" and "good" will be regarded as successful and the groups of "moderate" and "poor" as not successful. 4. Returning to sports level: the patient will be asked whether they are able to return to their sports level. It is a subdivis

Contacts

Public ContactJ.L. Tol

Medical Centre Antoniushove Department of Sports Medicine PO BOX 411

h.tol@mchaaglanden.nl+31 (0)70 3574235

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)