Lateral Epicondylitis of Elbow
Conditions
Keywords
Vitamin D3 injection, extensor strengthening exercise with counterforce brace, plasma Vitamin D3 level, visual analog scale of pain (VAS), Mayo Elbow Performance Score (MEPS), sonographic evaluation
Brief summary
The goal of this study is to verify the effect of vitamin D3 combined with extensor muscle strengthening exercise in lateral epicondylitis of elbow Are there significant differences in the improvement of functional scores between the study and control groups? Are there significant differences in the improvement of sonographic findings and blood D3 levels between the study and control groups? Participant will underwent D3 injection or saline injection and extensor muscle strengthening exercise with counter force brace. All the participant will undergo functional scoring, sonographic examination and blood D3 level testings until 6 months after initial visit.
Interventions
DRUGVitamin D3 or Saline injection at ipsilateral deltoid muscle
study group: 1.0mL Vitamin D3 injection control group: 1.0mL saline injection
Sponsors
Chuncheon Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
An independent nurse uses a random sequence generator and allocates the participants into the two groups. Participant, investigator and outcomes assessor were blinded of participants' information
Intervention model description
Study group: Vitamin D3 injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counterforce brace for lateral epicondylitis of elbow Control group: Saline injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counterforce brace for lateral epicondylitis of elbow
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* lateral epicondylitis(LE) of elbow symptoms that persisted of increased for more than 3 months in which LE was defined as pain on the lateral side of the elbow and pain at the lateral epicondyle upon direct palpation and during resisted dorsiflexion of the wrist
Exclusion criteria
* younger than 20 years * history of ipsilateral elbow surgery * common extensor tendon tears more than 30% in depth * inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, etc) * osteoarthritis with a limitation of range of motion (flexion contracture \>30 degree and further flexion \< 100 degree) * neurological deficits in the ipsilateral upper limb,and follow-ups less than 24 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analog scale of pain (VAS) | initial, Week 4, 12, 24 | 0-10, 0: no pain, 10: very severe pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's satisfaction | initial, Week 4, 12, 24 | 0-10, 0: not satisfied, 10: very much satisfied |
| Mayo Elbow Performance Score (MEPS) | initial, Week 4, 12, 24 | 0-100: higher score mean a better outcome |
| Grip power (attected/nonaffected) | initial, Week 4, 12, 24 | Newton/Newton |
| plasma Vitamin D level | initial, Week 4, 12, 24 | ng/mL |
| sonographic evaluation | initial, Week 4, 12, 24 | common extensor |
Countries
South Korea
Contacts
Primary ContactJung-Taek Hwang, MD, PhD
Backup ContactJu Sun Kim
Outcome results
None listed