Condition category
Injury, Occupational Diseases, Poisoning
Date applied
05/09/2011
Date assigned
26/09/2011
Last edited
24/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Dr Henning Langberg

ORCID ID

Contact details

Bispbjergbakke 23
Build 8
1st floor
Copenhagen
2400
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Local biochemical and morphological changes in human Achilles tendinopathy

Acronym

Study hypothesis

We hypothesize that several markers such as collagen 3 would be upregulated indicating formation of scar tissue with in the tendon along with decreased tissue quality and higher concentrations of MMP-2 and MMP-9 indicating an enhanced degradation of collagen structures in the area. Furthermore it is hypothesized that certain proteoglycans would have altered expression in the two tendon regions, e.g. a increased expression of decorin which might cause the collagen turnover to be increased also in chronic tendinopathy tendons. Additionally we hypothesize that growth factors like fibroblast growth factor (bFGF) is decreased causing a reduced healing capacity in the injured Achilles tendons.

Ethics approval

Scientific Ethics Committee of Copenhagen, Denmark, 18 January 2010, ref: H-1-2009-114

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Tendinoapthy is a general term for chronic tendon pain. the etiology is almost unknown. Despite of inflammation like symptoms, no inflammatory cells seem to be present in the disease.

Intervention

Thirty patients with chronic Achilles tendon pain were randomly assigned to either a Structural study (n=14) or a Biochemical study (n=16) by the envelope method.

Blood samples
Blood samples taken from a vein in the arm. Construction gives seconds discomfort. There is always, a very small, risk of infection and for inflammation of the vein, which we have not experienced in the attempt.

Ultrasound Scanning
Ultrasound examination or sonography, is widely used to display various organs and structures using ultrasonic waves. The present study uses a special doctor Audio Heads that radiates and receives ultrasonic pulses. When the sound head comes in close contact with skin, pulses are sent into the body, from which comes an echo that returns in different strengths, and through these echoes, the computer is able to display an image of the bodies, as you want to investigate. Echoes into a two dimensional black and white computer image, but using a different sonography methods, you get color images, where you can see the direction of flow, speed and force of blood flow in arteries and elsewhere.

Tendon biopsies
Tendon biopsies are taken under sterile conditions from the Achilles tendon unilaterally after local anesthesia of the skin using an automatic biopsy needle (1.6 mm and length 10 mm). The wounds are closed immediately after sampling. Biopsies weigh approx. 30 mg and will immediately upon removal be stored at minus 80° C until further processing. Biopsy might result in some discomfort that lasts a few seconds during the sampling and the tendon may be slightly sore for a few days after. There may be a little bleeding that can be stopped by compression. Very rarely local numbness may occur, however, this wears off in a few months. Furthermore, there is always a theoretical risk of infection through surgery, which never occurred on this section. Biopsies will be used to determine the turnover of the extracellular matrix of tendon, as well as for identifying growth factor activation.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Structural parameters: fibril density, fibril size, volume fraction of cells and the nucleus/cytoplasm ratio of cells were determined (measured at baseline)
2. Further gene expressions of various genes were analyzed including markers for collagen synthesis, collagen degradation, inflammation, wound healing, pain and fibrillogenesis (measured at baseline)

Secondary outcome measures

1. Visa A score
2. Activity levels
3. BMI calculations
4. Ultrasound and elastography analysis

Overall trial start date

01/07/2007

Overall trial end date

01/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with chronic tendon pain for more than 6 month were included

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

Patients who had received steroid injections less than six month ago were excluded

Recruitment start date

01/07/2007

Recruitment end date

01/09/2011

Locations

Countries of recruitment

Denmark

Trial participating centre

Bispbjergbakke 23
Copenhagen
2400
Denmark

Sponsor information

Organisation

Center for Healthy Aging, University of Copenhagen [Center for Sund Aldring] (Denmark)

Sponsor details

Faculty of Health Sciences
3B
Blegdamsvej
Copenhagen
DK-2200
Denmark

Sponsor type

University/education

Website

http://sundaldring.ku.dk/

Funders

Funder type

Other

Funder name

Danish Rheumatism Association

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The NovoNordic Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Danish Ministry of Culture Committee for Sports Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Danish Medical Research Council (ref: 22-04-0191)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Nordea foundation (Healthy Aging Grant)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22480275

Publication citations

  1. Results

    J P, U F, K Q, J O L, P S, K H, M K, H L, Local biochemical and morphological differences in human Achilles tendinopathy: a case control study., BMC Musculoskelet Disord, 2012, 13, 53, doi: 10.1186/1471-2474-13-53.

Additional files

Editorial Notes