Lateral epicondylitis Musculoskeletal Diseases Lateral epicondylitis
Conditions
Sponsors
Bio Minerals NV
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Elbow pain severity measured using a visual analog scale (VAS, 100mm) at baseline and 20 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium
Contacts
Public ContactMattias Bonnarens
Outcome results
None listed