Condition category
Musculoskeletal Diseases
Date applied
04/09/2020
Date assigned
15/09/2020
Last edited
14/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Lateral epicondylitis, also known as "Tennis Elbow", is the most common overuse syndrome in the elbow. Most of the traditional treatments such as anti-inflammatory medications, rest, physical therapy and corticosteroid injections do not alter the tendon's poor healing properties.
Choline-stabilized orthosilicic acid has been reported to improve the symptoms of soft tissue injuries (i.e. pain relief and improved mobility).
This study will investigate whether choline-stabilized orthosilicic acid can relieve the symptoms of epicondylitis.

Who can participate?
Adults between the ages of 18 and 70 with epicondylitis symptoms lasting 12 weeks or longer

What does the study involve?
Patients are randomly allocated to either receive choline-stabilized orthosilicic acid or placebo (dummy capsule). All patients will be instructed to take two capsules daily for 20 weeks. Assessments will be done at the screening visit, inclusion to the study, and after 5, 10, 15 and 20 weeks of treatment. If necessary, rescue medication in the form of paracetamol (up to 4 g/day) is permitted up to 48 hours before the baseline visit and other study visits.

What are the possible benefits and risks of participating?
Choline-stabilized orthosilicic acid may support soft tissue healing. Considering the available information about choline-stabilized orthosilicic acid, there are no foreseeable risks to human health when used as instructed.

Where is the study run from?
Bio Minerals NV (Belgium)

When is the study starting and how long is it expected to run for?
March 2017 to June 2021

Who is funding the study?
Bio Minerals NV (Belgium)

Who is the main contact?
Prof. Dr Alexander Van Tongel
alexander.vantongel@ugent.be

Trial website

Contact information

Type

Public

Primary contact

Ms Ine De Cock

ORCID ID

http://orcid.org/0000-0001-6428-3482

Contact details

Zenderstraat 12
Destelbergen
9070
Belgium
+32 (0)9 228 20 00
ine.decock@biominerals.be

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

17/3

Study information

Scientific title

A randomized, double-blind placebo-controlled study to assess the effect of choline-stabilized orthosilicic acid on lateral epicondylitis

Acronym

Study hypothesis

The aim of the study is to evaluate the effect of oral intake of choline-stabilized orthosilicic acid over a 20 week period on the symptoms of lateral epicondylitis.

Ethics approval

Approved 05/03/2018, Central ethical committee: Commission for Medical Ethics/Commissie voor Medische Ethiek (UZ Gent, entrance 75, route 7522, Corneel Heymanslaan 10, 9000 Gent, Belgium; +32 (0)9 332 49 62; ethisch.comite@uzgent.be), ref: not provided

Study design

Multi-center double-blind randomized placebo-controlled phase III study

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 contact details to request a participant information sheet.

Condition

Lateral epicondylitis

Intervention

Participants are randomized to either the placebo or active treatment group (choline-stabilized orthosilicic acid) using block randomization in a ratio of 1:1.

All participants will be instructed to take daily for 20 weeks, two capsules orally of either placebo (520 mg microcrystalline cellulose beadlets), or the active ingredient (520 mg beadlets containing 5 mg of silicon and 100 mg of choline in the form of choline-stabilized orthosilicic acid). The trial starts with a screening visit and a wash-out period during which the use of lateral epiconylititis treatment is not permitted.

Assessments will be done respectively at inclusion (baseline), and after 5, 10, 15 and 20 weeks of treatment. If necessary, rescue medication under the form of paracetamol (up to 4g/day) is permitted up to 48 hours before the baseline visit and other study visits.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Elbow pain severity measured using a visual analog scale (VAS, 100mm) at baseline and 20 weeks

Secondary outcome measures

1. Disabilities of the Arm, Shoulder and Hand (DASH) score measured using DASH questionnaire at baseline, 5, 10, 15 and 20 weeks
2. Patient-Rated Tennis Elbow Evaluation (PRTEE) score measured using PRTEE questionnaire at baseline, 5, 10, 15 and 20 weeks
3. Elbow pain severity measured using a visual analog scale (VAS, 100, mm) at baseline, 5, 10 and 15 weeks
4. Pain-free grip strengths and maximum grip strength measured using a GRIP-D meter at baseline, 5, 10, 15 and 20 weeks
5. Echogenicity and vascularity measured by color Doppler sonography at screening or baseline, 10 and 20 weeks
6. Use of paracetamol as rescue medication measured using patient report at baseline, 5, 10, 15 and 20 weeks
7. Biomarkers of collagen metabolism measured using serum and urine samples at baseline, 10 and 20 weeks
8. Serum markers of inflammation measured using serum samples at baseline, 10 and 20 weeks

Overall trial start date

28/03/2017

Overall trial end date

30/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Provision of written informed consent
2. Males, pre-menopausal females, peri- or post-menopausal females currently taking hormone replacement therapy between the ages of 18 and 70 years old
3. Females must use an approved form of birth control
4. Painful, chronic tendinopathy present in lateral elbow in one arm. The baseline elbow is > 40 on a scale of 100 mm (VAS: "0" representing no pain and "100" worst imaginable pain) during elbow extension and resisted wrist extension (Cozen's test)
5. The epicondylitis symptoms lasting at least 12 weeks or longer
6. A history of at least two periods of elbow pain lasting >10 days
7. BMI between 18.5 and 35 kg/m²
8. Participant must continue his/her normal physical activities during the study i.e. there should be no change in physical activity after the screening visit

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

130

Participant exclusion criteria

1. Unable to understand the study procedures and/or not wishing to participate in one of the subsequent therapeutic intervention protocols
2. Poor general health interfering with compliance or assessment
3. Unlikely to co-operate fully in the study
4.. Participating in another clinical trial in the last 90 days
5. Pregnancy or breastfeeding
6. Radiological examinations show abnormalities such as arthritis and inflammatory arthropathy of the elbow joint in the target arm
7. Participants with a history of trauma, ligament damage, fracture, tumor or surgery of the elbow joint in the target arm
8. Proven and current symptomatic peripheral nerve entrapment syndrome
9. Proven and current symptomatic cervical facet arthrosis: C5-C6/C6-C7
10. Proven and current symptomatic radiculopathy
11. Fibromyalgia, chronic fatigue syndrome
12. New physical activity i.e. physical activity which was not present prior to the screening visit
13. Recent or current alcohol abuse
14. Participants with documented, active infection diseases such as HIV or hepatitis B/C
15. Clinically significant medical abnormalities which would make the subject unsuitable for the study, as judged by the investigator, such as mental disorders
16. Participant has documented renal failure, history of stroke, myocardial infarct or cancer
17. Concomitant and previous medication
17.1. Less than 6 months between the local treatment of epicondylitis with platelet-rich plasma (PRP), autologous conditioned plasma (ACP) or autologous whole blood (AWB) injections and inclusions in the study
17.2. Less than 3 months between the local treatment of epicondylitis with shockwaves or steroid injections and inclusion in the study
17.3. Less than 6 weeks between the local treatment of epicondylitis with botulinum toxin, glycosaminoglycan polysulfate (hyaluronic acid) or dextrose injections and inclusion in the study
17.4. Less than 15 days between the treatment and inclusion in the study: systemic or topical use of NSAIDs and analgesics, different from paracetamol; systemic opoids and corticosteroids; treatment for epicondylitis with acupuncture or physiotherapy
17.5. Less than 3 months between supplementation with food supplements containing horsetail extract, bamboo extract, silicic acid or silanol derivatives and inclusion in the study

Recruitment start date

24/05/2018

Recruitment end date

31/01/2021

Locations

Countries of recruitment

Belgium

Trial participating centre

Ghent University Hospital
Department of Physical and Rehabilitation Medicine Corneel Heymanslaan 10
Ghent
9000
Belgium

Trial participating centre

Ghent University Hospital
Department of Orthopaedic Surgery and Traumatology Corneel Heymanslaan 10
Ghent
9000
Belgium

Trial participating centre

AZ Monica
Department of Orthopaedic Surgery Stevenslei 20
Deurne
2100
Belgium

Trial participating centre

Ziekenhuis Oost-Limburg
Schiepse Bos 6
Genk
3600
Belgium

Trial participating centre

AZ Sint-Lucas Gent
Department of Orthopaedic Surgery Groenebriel 1
Ghent
9000
Belgium

Trial participating centre

AZ Sint-Lucas Brugge
Department of Orthopaedic Surgery Sint-Lucaslaan 29
Brugge
8310
Belgium

Trial participating centre

AZ Sint-Lucas Brugge
Revalidatiecentrum Sint-Lucaslaan 29
Brugge
8310
Belgium

Trial participating centre

AZ Sint-Jan Brugge
Department of Orthopaedic Surgery Ruddershove 10
Brugge
8000
Belgium

Trial participating centre

UZ Antwerpen
Department Physical Medicine and Rehabilitation Wilrijkstraat 10
Edegem-Antwerp
2650
Belgium

Trial participating centre

Sportpraktijk De Merode
De Merodelei 197
Turnhout
2300
Belgium

Trial participating centre

Sportartsenpraktijk
Michel Wittockstraat 21/001
Wilrijk
2610
Belgium

Sponsor information

Organisation

Bio Minerals NV

Sponsor details

Zenderstraat 12
Destelbergen
9070
Belgium
+32 (0) 9 228 20 00
ine.decock@biominerals.be

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Bio Minerals NV

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Planned publication in a high-impact peer-reviewed journal.
2. Participants can contact the principal investigator to get access to their raw data and for discussion.
3. No additional files will be available.

IPD sharing statement
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/09/2020: Trial's existence confirmed by Commission for Medical Ethics, UZ Gent.