Vitamin D3 Combined With Strengthening Exercise for Lateral Epicondylitis of Elbow

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Vitamin D3 Combined With Extensor Muscle Strengthening Exercise in Lateral Epicondylitis of Elbow: a Randomized Controlled Trial

Conditions
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Lateral Epicondylitis of Elbow

Intervention / Treatment
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* Drug: Vitamin D3 or Saline injection at ipsilateral deltoid muscle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3 injection<br>1.0mL Vitamin D3 injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counter force brace in lateral epicondylitis of elbow | Drug: Vitamin D3 or Saline injection at ipsilateral deltoid muscle<br>* study group: 1.0mL Vitamin D3 injection control group: 1.0mL saline injection<br>* Other names: extensor muscle strengthening exercise with counterforce brace;|
| Placebo Comparator: Saline injection<br>1.0mL saline injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counter force brace in lateral epicondylitis of elbow | Drug: Vitamin D3 or Saline injection at ipsilateral deltoid muscle<br>* study group: 1.0mL Vitamin D3 injection control group: 1.0mL saline injection<br>* Other names: extensor muscle strengthening exercise with counterforce brace;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale of pain (VAS) | 0-10, 0: no pain, 10: very severe pain | initial, Week 4, 12, 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's satisfaction | 0-10, 0: not satisfied, 10: very much satisfied | initial, Week 4, 12, 24 | 
| Mayo Elbow Performance Score (MEPS) | 0-100: higher score mean a better outcome | initial, Week 4, 12, 24 | 
| Grip power (attected/nonaffected) | Newton/Newton | initial, Week 4, 12, 24 | 
| plasma Vitamin D level | ng/mL | initial, Week 4, 12, 24 | 
| sonographic evaluation | common extensor | initial, Week 4, 12, 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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