Hyaluronan in the Treatment of Painful Achilles Tendinopathy.

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.

Study Overview

• Status: Completed
• Conditions: Tendinopathy
• Intervention / Treatment: Device: ESWT; Device: hyaluronic acid sodium salt

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie
• Germany
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52062
      • Praxiszentrum Orthopädie-Unfallchirurgie Nordrhein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ESWT (Extracorporal Shock Wave Therapy); Three applications in weekly interval.	Device: ESWT
Active Comparator: hyaluronic acid sodium salt; Two injections of 2% (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval.	Device: hyaluronic acid sodium salt; Other Names: OSTENIL® TENDON

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 0
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 7 (plus or minus 1 day)
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 28 (plus or minus 3 days)
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 180 (plus or minus 3 days)
Visual Analogue Scale of pain (VAS; 100 mm)	Intensity of pain will be evaluated on the Huskisson VAS pain scale on which 0 mm indicate 'no pain' and 100 mm indicate 'extreme pain'.	Day 0
Visual Analogue Scale of pain (VAS; 100 mm)	Intensity of pain will be evaluated on the Huskisson VAS pain scale on which 0 mm indicate 'no pain' and 100 mm indicate 'extreme pain'.	Day 7 (plus or minus 1 day)
Visual Analogue Scale of pain (VAS; 100 mm)	Intensity of pain will be evaluated on the Huskisson VAS pain scale on which 0 mm indicate 'no pain' and 100 mm indicate 'extreme pain'.	Day 28 (plus or minus 3 days)
Visual Analogue Scale of pain (VAS; 100 mm)	Intensity of pain will be evaluated on the Huskisson VAS pain scale on which 0 mm indicate 'no pain' and 100 mm indicate 'extreme pain'.	Day 90 (plus or minus 3 days)
Visual Analogue Scale of pain (VAS; 100 mm)	Intensity of pain will be evaluated on the Huskisson VAS pain scale on which 0 mm indicate 'no pain' and 100 mm indicate 'extreme pain'.	Day 180 (plus or minus 3 days)
Patient's and investigator's global evaluation of study-relevant tendon complaints	Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.	Day 7 (plus or minus 1 day)
Patient's and investigator's global evaluation of study-relevant tendon complaints	Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.	Day 28 (plus or minus 3 days)
Patient's and investigator's global evaluation of study-relevant tendon complaints	Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.	Day 90 (plus or minus 3 days)
Patient's and investigator's global evaluation of study-relevant tendon complaints	Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.	Day 180 (plus or minus 3 days)
Clinical Parameters	Redness; Warmth; Swelling; Tenderness on palpation; Crepitus on motion; Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.	Day 0
Clinical Parameters	Redness; Warmth; Swelling; Tenderness on palpation; Crepitus on motion; Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.	Day 7 (plus or minus 1 day)
Clinical Parameters	Redness; Warmth; Swelling; Tenderness on palpation; Crepitus on motion; Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.	Day 28 (plus or minus 3 days)
Clinical Parameters	Redness; Warmth; Swelling; Tenderness on palpation; Crepitus on motion; Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.	Day 90 (plus or minus 3 days)
Clinical Parameters	Redness; Warmth; Swelling; Tenderness on palpation; Crepitus on motion; Accumulation of tissue fluid Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.	Day 180 (plus or minus 3 days)
Frequency of test product-related Adverse Events		Up to Day 180

Collaborators and Investigators

• Sponsor: TRB Chemedica AG
• Investigators: Principal Investigator: Thierry De Vroey, Dr. med., Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie; Principal Investigator: Nils Lynen, Dr. med., Praxiszentrum Orthopädie-Unfallchirurgie Nordrhein

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 26, 2013
• First Submitted That Met QC Criteria: September 26, 2013
• First Posted (Estimate): October 1, 2013

Study Record Updates

• Last Update Posted (Estimate): November 9, 2015
• Last Update Submitted That Met QC Criteria: November 6, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: tendon; hyaluronic acid; tendinopathy; hyaluronan; extracorporeal shock wave
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: OTENA-INT-2013-03; CIV-13-07-011543 (Other Identifier: EUDAMED)