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TendinopathyNCT01954108

Hyaluronan in the Treatment of Painful Achilles Tendinopathy.

A study testing hyaluronic acid sodium salt and ESWT in people with Tendinopathy, run by TRB Chemedica AG at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Tendinopathy
What is being tested?
hyaluronic acid sodium salt and ESWT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
2 sitesin 2 countries
Study dates
Dec 2013to Oct 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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).

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Belgium1 site

  • Universitair Ziekenhuis Antwerpen, Fysische Geneeskunde en Revalidatie

    Edegem, 2650

Other trials in Belgium

Germany1 site

  • Praxiszentrum Orthopädie-Unfallchirurgie Nordrhein

    Aachen, North Rhine-Westphalia, 52062

Other trials in Germany

About this study

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
Being tested
hyaluronic acid sodium salt, ESWT
Keywords
tendinopathy, hyaluronan, tendon, hyaluronic acid, extracorporeal shock wave
Medical subject headings
Tendinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hyaluronic acid sodium saltDevice

    Also called OSTENIL® TENDON

  • ESWTDevice

Study groups in NCT01954108
Study groupRoleWhat they receive
ESWT (Extracorporal Shock Wave Therapy)OtherThree applications in weekly interval.
Receives: Device: ESWT
hyaluronic acid sodium saltActive comparatorTwo injections of 2% (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval.
Receives: Device: hyaluronic acid sodium salt

What is being measured

The primary outcome is the main question the study is designed to answer.

  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'.

    Measured: Day 90 (plus or minus 3 days)

Secondary outcomes (19)

  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'.

    Measured: Day 0

  2. 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'.

    Measured: Day 7 (plus or minus 1 day)

  3. 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'.

    Measured: Day 28 (plus or minus 3 days)

  4. 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'.

    Measured: Day 180 (plus or minus 3 days)

  5. 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'.

    Measured: Day 0

  6. 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'.

    Measured: Day 7 (plus or minus 1 day)

  7. 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'.

    Measured: Day 28 (plus or minus 3 days)

  8. 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'.

    Measured: Day 90 (plus or minus 3 days)

  9. 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'.

    Measured: Day 180 (plus or minus 3 days)

  10. 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.

    Measured: Day 7 (plus or minus 1 day)

  11. 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.

    Measured: Day 28 (plus or minus 3 days)

  12. 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.

    Measured: Day 90 (plus or minus 3 days)

  13. 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.

    Measured: Day 180 (plus or minus 3 days)

  14. 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.

    Measured: Day 0

  15. 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.

    Measured: Day 7 (plus or minus 1 day)

  16. 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.

    Measured: Day 28 (plus or minus 3 days)

  17. 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.

    Measured: Day 90 (plus or minus 3 days)

  18. 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.

    Measured: Day 180 (plus or minus 3 days)

  19. Frequency of test product-related Adverse Events

    Measured: Up to Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionJul 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01954108
Sponsor's protocol ID
OTENA-INT-2013-03
Other IDs
CIV-13-07-011543
Status last verified
Nov 2015
First submitted
26 Sep 2013
Last updated
9 Nov 2015
Results posted
No
Data monitoring committee
No

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.

    PubMed 27639439

Questions about this trial

What is this clinical trial studying?

A study testing hyaluronic acid sodium salt and ESWT in people with Tendinopathy, run by TRB Chemedica AG at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Victorian Institute of Sports Assessment-Achilles (VISA-A score) (time frame: Day 90 (plus or minus 3 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01954108, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2015.

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