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A trial comparing platelet-rich plasma, autologous blood and dry needling for chronic patellar tendinopathy

Double-blind randomized controlled trial comparing platelet-rich plasma, autologous blood and dry needling for chronic patellar tendinopathy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN93328851
Enrollment
111
Registered
2013-07-19
Start date
2012-06-05
Completion date
Unknown
Last updated
2019-02-11

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

Conditions

Patellar tendinopathy Musculoskeletal Diseases Patellar tendinitis

Interventions

Dry needling: will be injected through one skin portal with a 22-gauge needle and be anesthetized with a 1:1 mixture of 2% lidocaine and bupivacaine 0,5%. We will then proceed within the abnormal tend

Sponsors

Arthrex Inc. (USA)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. History (> 3 mo) of exercise-associated pain along the proximal insertion of the patellar tendon or pain or tenderness on palpation at this site or pain during provocative tests of the knee extensors 2. And having one of the following ultrasound finding: 2.1. Hypoechoic regions 2.2. Intratendinous tears 2.3. Neovascularisation 3. Being at least 18 years old, either sex

Exclusion criteria

Exclusion criteria: 1. Bleeding disorders (hemophilia) 2. Taking anticoagulants (except aspirin) 3. Severe anemia 4. Cancer or metastases 5. Pregnant or breastfeeding women 6. Presence of infection at the time of evaluation 7. History of knee surgery 8. Inflammatory arthritis affecting the knee 9. Corticosteroid injections within 30 days preceding the study

Design outcomes

Primary

MeasureTime frame
All the subjects will complete a baseline evaluation including: 1. An ultrasound assessment (based on the sonographic features used by Ryan (28). We will compare: tendon thickness, area of hypoechoic region in mm in three axes, severity of hypoechoic area according to a 0-3 ordinal scale, presence of intratendinous tear, mean length of intratendinous tear, presence of intratendinous calcification and finally the extent of neovascularity with colour flow Doppler. Those features will be recorded at each visit.), 2. Two different visual analogue scales (VAS): The VAS-pain and VAS-function will be measured with a scaled line from 0 to 100 mm. The subject will indicate on the scale the level of their pain and functional capacity of their knee during the last week. 3. The Victorian Institute of Sport Assessment Questionnaire (VISA-P, to assess the severity of symptoms in athletes with patellar tendinopathy. Currently, it is the only specific scale for patellar tendinopathy). The baseline evaluation will also include question about: 1. Demographic variables (name, address, age, gender, and e-mail address) 2. Sports participation: type and level of sport and mean hours of sports participation and sport history) 3. Medical history (knee injuries and previous medical treatment)

Secondary

MeasureTime frame
Follow-up measurements: 1. VISA-P (to assess the severity of symptoms in athletes with patellar tendinopathy. Currently, it is the only specific scale for patellar tendinopathy), 2. VAS: The VAS-pain and VAS-function will be measured with a scaled line from 0 to 100 mm. The subject will indicate on the scale the level of their pain and functional capacity of their knee during the last week. 3. Ultrasound assessments (based on the sonographic features used by Ryan). We will compare: tendon thickness, area of hypoechoic region in mm in three axes, severity of hypoechoic area according to a 0-3 ordinal scale, presence of intratendinous tear, mean length of intratendinous tear, presence of intratendinous calcification and finally the extent of neovascularity with colour flow Doppler. Those features will be recorded at each visit.) Measurements will be carried out at 1, 3, 6 and 12 months. Side effects and adverse reactions/events and the rate of overall treatment satisfaction will also be recorded.

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026