NCT01954108

Brief Summary

The primary objective of this study is to compare OSTENIL® TENDON (2% hyaluronan) and Extracorporeal Shock Wave (ESWT) therapy in the treatment of painful Achilles tendinopathy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

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

First Submitted

Initial submission to the registry

September 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 9, 2015

Status Verified

November 1, 2015

Enrollment Period

1.6 years

First QC Date

September 26, 2013

Last Update Submit

November 6, 2015

Conditions

Tendinopathy

Keywords

tendinopathyhyaluronantendonhyaluronic acidextracorporeal shock wave

Outcome Measures

Primary Outcomes (1)

  • Victorian Institute of Sports Assessment-Achilles (VISA-A score)

    The validated questionnaire will be used to evaluate the outcome in Achilles tendinopathy. The score ranges from '0' to '100' whereas '0' denotes 'no activity / maximum pain' and '100' denote 'maximum activity / no pain'.

    Day 90 (plus or minus 3 days)

Secondary Outcomes (19)

  • Victorian Institute of Sports Assessment-Achilles (VISA-A score)

    Day 0

  • Victorian Institute of Sports Assessment-Achilles (VISA-A score)

    Day 7 (plus or minus 1 day)

  • Victorian Institute of Sports Assessment-Achilles (VISA-A score)

    Day 28 (plus or minus 3 days)

  • Victorian Institute of Sports Assessment-Achilles (VISA-A score)

    Day 180 (plus or minus 3 days)

  • Visual Analogue Scale of pain (VAS; 100 mm)

    Day 0

  • +14 more secondary outcomes

Study Arms (2)

ESWT (Extracorporal Shock Wave Therapy)

OTHER

Three applications in weekly interval.

Device: ESWT

hyaluronic acid sodium salt

ACTIVE COMPARATOR

Two injections of 2% (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval.

Device: hyaluronic acid sodium salt

Interventions

hyaluronic acid sodium saltDEVICE
Also known as: OSTENIL® TENDON
hyaluronic acid sodium salt
ESWTDEVICE
ESWT (Extracorporal Shock Wave Therapy)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients between 18 and 75 years of age.
  • Good general health condition.
  • Signed written informed consent.
  • Painful Achilles midportion tendinopathy since more or equal than 6 weeks.
  • Pain according to VAS (Huskisson, 100 mm) more or equal than 40 mm.
  • Ensured compliance of subjects over the whole study period.

You may not qualify if:

  • Infection or relevant skin disease at study relevant site.
  • Blood coagulation disorder or intake of blood thinner (e.g. Marcumar).
  • Known hypersensitivity to hyaluronic acid (HA) preparations or to the constituents mannitol, sodium chloride, disodium phosphate and sodium dihydrogenphosphate.
  • Contra-indications for ESWT application in study relevant area (e.g. recent surgery, malignant tumour, local osteomyelitis or open epiphysis).
  • Severe intercurrent illness (e.g. uncontrolled diabetes mellitus, peripheral neuropathy), which in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study.
  • Concomitant disease at study relevant site (e.g. insertion tendinopathy at Achilles tendon) influencing study evaluation.
  • Diseases or characteristics judged by the investigator to be incompatible with the assessments and/or procedures for the study evaluation.
  • Intake of concomitant medications not allowed which might interfere with the functional assessment of the study (e.g. immunosuppressive drugs within the last 3 months).
  • Use of NSAIDs within the last week prior to study treatment.
  • Recent history of drug and/or alcohol abuse (within the last 6 months).
  • Pregnant or lactating females.
  • Participants of childbearing age (pre-menopausal) who do not accept the use of methods of birth control with pearl index of at least 1 (i.e. oral contraceptives, vaginal ring, hormone-releasing Intrauterine Device (IUD), implants, depot syringes, hormone patch, double barrier method, tubal ligation, vasectomised partner,…) during the treatment period and the first 4 weeks of follow-up period.
  • Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts.
  • Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie

Edegem, 2650, Belgium

Location

Praxiszentrum Orthopädie-Unfallchirurgie Nordrhein

Aachen, North Rhine-Westphalia, 52062, Germany

Location

Related Publications (1)

  • Lynen N, De Vroey T, Spiegel I, Van Ongeval F, Hendrickx NJ, Stassijns G. Comparison of Peritendinous Hyaluronan Injections Versus Extracorporeal Shock Wave Therapy in the Treatment of Painful Achilles' Tendinopathy: A Randomized Clinical Efficacy and Safety Study. Arch Phys Med Rehabil. 2017 Jan;98(1):64-71. doi: 10.1016/j.apmr.2016.08.470. Epub 2016 Sep 14.

    PMID: 27639439DERIVED

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Study Officials

  • Thierry De Vroey, Dr. med.

    Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie

    PRINCIPAL INVESTIGATOR

  • Nils Lynen, Dr. med.

    Praxiszentrum Orthopädie-Unfallchirurgie Nordrhein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2013

First Posted

October 1, 2013

Study Start

December 1, 2013

Primary Completion

July 1, 2015

Study Completion

October 1, 2015

Last Updated

November 9, 2015

Record last verified: 2015-11

Locations

BE(1)DE(1)