To monitor the potential clinical improvement of treatment of tendon injuries with PRP and to evaluate the recovery process in time using the new UTC method.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measurement: VISA-A score, a validated instrument to detect the
severity of symptoms in patients with Achilles tendinopathy.
Secondary outcome
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 developed, that provides quantitative information on tendon
fiber alignment and the related ultra-structural integrity of the tendon tissue
through a non-invasive approach.
Background summary
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 anesthetic agent.
Study objective
To monitor the potential clinical improvement of treatment of tendon injuries
with PRP and to evaluate the recovery process in time using the new UTC method.
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.
Intervention
All patients will perform a heavy load eccentric exercise programme, consisting
of 180 repetitions daily. The patients will be randomized into 2 treatment
groups: ultrasound guided intratendinous saline injection with eccentric
exercises and ultrasound guided intratendinous PRP injection with eccentric
exercises.
Study burden and risks
The intratendinous injections may be painful and a hematoma can arise. In
previous studies on the effect of autologous blood injections or injection with
PRP on tendon disorders at other locations, it was reported that no tendon
ruptures occured. However, we are not sure whether these results could be
extrapolated to the Achilles tendon.
The eccentric exercises are frequently painful and it requires discipline.
Moreover, there are 4 follow-up moments for the patients after inclusion (with
the duration of 45 minutes per appointment).
dr. Molenwaterplein 50
3015 GE Rotterdam
Nederland
dr. Molenwaterplein 50
3015 GE Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
1.Pain on palpation 2-7 cm proximal from the tendon insertion ("midportion")
2.Symptoms > 2 months
3.Age 18-70 years
Exclusion criteria
1.Insertional Achilles tendinopathy
2.Achilles tendon rupture
3.Tenosynovitis of the plantar flexors
4.Sural nerve pathology
5.(sub)luxation mm. Peroneï
6.Suspicion of a systemic disease:spondylarthropathy, gout, hyperlipidemia, Rheumatoid Arthritis en sarcoidosis
7.Inability to perform a heavy load exercise programme
8.Previous performance of heavy load eccentric exercise programme according to Alfredson et al. (12 weeks)
9.Previous injection with PRP for the same injury
10.Unwillingness of the patient to participate in one of the two treatment groups
11.presence of a pregnancy
12.Prescribed drugs with a putative effect on symptoms and tendon healing, for example quinolone antibiotics
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22805.098.08 |