NCT00761423

Brief Summary

The study will be a double-blind randomized single-center clinical trial comparing 3 treatment groups with chronic midportion Achilles tendinopathy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

September 25, 2008

Last Update Submit

May 17, 2017

Conditions

Achilles Tendinopathy

Outcome Measures

Primary Outcomes (1)

  • VISA-A Score

    6, 12, 24 and 52 weeks

Secondary Outcomes (5)

  • Ultrasonographic Tissue Characterization

    6,12, 24 and 52 weeks

  • Complications

    Anytime

  • Power doppler sound

    6, 12, 24 and 52 weeks

  • Patient satisfaction

    6, 12, 24 and 52 weeks

  • Return to sport

    6, 12, 24 and 52 weeks

Study Arms (2)

1

EXPERIMENTAL

Combination of eccentric exercises and injection of PRP

Biological: PRP Injection with eccentric exercises

2

PLACEBO COMPARATOR

Combination of eccentric exercises and physiological saline injection

Biological: Placebo Injection with eccentric exercises

Interventions

PRP Injection with eccentric exercisesBIOLOGICAL

PRP Injection with eccentric exercises

1
Placebo Injection with eccentric exercisesBIOLOGICAL

Placebo Injection with eccentric exercises

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis "chronic midportion Achilles tendinopathy"
  • Age 18-70 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus Medical Center

Rotterdam, Netherlands

Location

Related Publications (2)

  • Lagas IF, Tol JL, Weir A, de Jonge S, van Veldhoven PLJ, Bierma-Zeinstra SMA, Verhaar JAN, de Vos RJ. One fifth of patients with Achilles tendinopathy have symptoms after 10 years: A prospective cohort study. J Sports Sci. 2022 Nov;40(22):2475-2483. doi: 10.1080/02640414.2022.2163537. Epub 2023 Jan 8.

    PMID: 36617848DERIVED

  • de Vos RJ, Weir A, van Schie HT, Bierma-Zeinstra SM, Verhaar JA, Weinans H, Tol JL. Platelet-rich plasma injection for chronic Achilles tendinopathy: a randomized controlled trial. JAMA. 2010 Jan 13;303(2):144-9. doi: 10.1001/jama.2009.1986.

    PMID: 20068208DERIVED

Study Officials

  • RJ De Vos, MD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 29, 2008

Study Start

August 1, 2008

Primary Completion

February 1, 2009

Study Completion

August 1, 2009

Last Updated

May 18, 2017

Record last verified: 2017-05

Locations

NL(1)