Hyaluronan in the Treatment of Painful Achilles Tendinopathy.

NCT ID: NCT01954108

Last Updated: 2015-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-10-31

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.

Conditions

Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ESWT (Extracorporal Shock Wave Therapy)

Three applications in weekly interval.

Group Type: OTHER

ESWT

Intervention Type: DEVICE

hyaluronic acid sodium salt

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

Group Type: ACTIVE_COMPARATOR

hyaluronic acid sodium salt

Intervention Type: DEVICE

Interventions

hyaluronic acid sodium salt

Intervention Type: DEVICE

ESWT

Intervention Type: DEVICE

Other Intervention Names

OSTENIL® TENDON

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Concomitant or previous participation in a clinical investigation within the last 3 months prior to study inclusion.
• 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).
• Previous therapies (except non-steroidal anti-inflammatory drugs (NSAID)) at study relevant site within the last 4 weeks prior to study inclusion.
• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TRB Chemedica AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry De Vroey, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie

Nils Lynen, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Praxiszentrum Orthopädie-Unfallchirurgie Nordrhein

Locations

Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie

Edegem, , Belgium

Praxiszentrum Orthopädie-Unfallchirurgie Nordrhein

Aachen, North Rhine-Westphalia, Germany

Countries

Belgium; Germany

References

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.

Reference Type: DERIVED

PMID: 27639439 (View on PubMed)

Other Identifiers

CIV-13-07-011543

Identifier Type: OTHER

Identifier Source: secondary_id

OTENA-INT-2013-03

Identifier Type: -

Identifier Source: org_study_id