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Completed

NCT Number: NCT01954108

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.

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Key information

Conditions

Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie, Edegem, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

hyaluronic acid sodium salt

Device

Other names: OSTENIL® TENDON

ESWT

Device

Primary outcomes

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

    Time frame: Day 90 (plus or minus 3 days)

    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'.

Secondary outcomes

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

    Time frame: Day 0

    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'.

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

    Time frame: Day 7 (plus or minus 1 day)

    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'.

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

    Time frame: Day 28 (plus or minus 3 days)

    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'.

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

    Time frame: Day 180 (plus or minus 3 days)

    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'.

  5. Visual Analogue Scale of pain (VAS; 100 mm)

    Time frame: Day 0

    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'.

  6. Visual Analogue Scale of pain (VAS; 100 mm)

    Time frame: Day 7 (plus or minus 1 day)

    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'.

  7. Visual Analogue Scale of pain (VAS; 100 mm)

    Time frame: Day 28 (plus or minus 3 days)

    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'.

  8. Visual Analogue Scale of pain (VAS; 100 mm)

    Time frame: Day 90 (plus or minus 3 days)

    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'.

  9. Visual Analogue Scale of pain (VAS; 100 mm)

    Time frame: Day 180 (plus or minus 3 days)

    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'.

  10. Patient's and investigator's global evaluation of study-relevant tendon complaints

    Time frame: Day 7 (plus or minus 1 day)

    Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.

  11. Patient's and investigator's global evaluation of study-relevant tendon complaints

    Time frame: Day 28 (plus or minus 3 days)

    Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.

  12. Patient's and investigator's global evaluation of study-relevant tendon complaints

    Time frame: Day 90 (plus or minus 3 days)

    Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.

  13. Patient's and investigator's global evaluation of study-relevant tendon complaints

    Time frame: Day 180 (plus or minus 3 days)

    Measured by Clinical Global Impression (CGI) 7-point scale, ranking from 'very much improved' to 'very much worse' condition.

  14. Clinical Parameters

    Time frame: Day 0

    • Redness
    • Warmth
    • Swelling
    • Tenderness on palpation
    • Crepitus on motion
    • Accumulation of tissue fluid

    Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.

  15. Clinical Parameters

    Time frame: Day 7 (plus or minus 1 day)

    • Redness
    • Warmth
    • Swelling
    • Tenderness on palpation
    • Crepitus on motion
    • Accumulation of tissue fluid

    Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.

  16. Clinical Parameters

    Time frame: Day 28 (plus or minus 3 days)

    • Redness
    • Warmth
    • Swelling
    • Tenderness on palpation
    • Crepitus on motion
    • Accumulation of tissue fluid

    Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.

  17. Clinical Parameters

    Time frame: Day 90 (plus or minus 3 days)

    • Redness
    • Warmth
    • Swelling
    • Tenderness on palpation
    • Crepitus on motion
    • Accumulation of tissue fluid

    Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.

  18. Clinical Parameters

    Time frame: Day 180 (plus or minus 3 days)

    • Redness
    • Warmth
    • Swelling
    • Tenderness on palpation
    • Crepitus on motion
    • Accumulation of tissue fluid

    Measured by 5-point scale, ranking from 'none' to 'extreme' intensity.

  19. Frequency of test product-related Adverse Events

    Time frame: Up to Day 180

Sponsors and collaborators

Lead sponsor

TRB Chemedica AG

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 1, 2013
Registry last updated
Nov 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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