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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 injection | Experimental | 1.0mL Vitamin D3 injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counter force brace in lateral epicondylitis of elbow |
|
| Saline injection | Placebo Comparator | 1.0mL saline injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counter force brace in lateral epicondylitis of elbow |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 or Saline injection at ipsilateral deltoid muscle | Drug | study group: 1.0mL Vitamin D3 injection control group: 1.0mL saline injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| visual analog scale of pain (VAS) | 0-10, 0: no pain, 10: very severe pain | initial, Week 4, 12, 24 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-Taek Hwang, MD, PhD | Contact | +82332405197 | DRAKEHJT@HANMAIL.NET | |
| Ju Sun Kim | Contact | +332405198 | wntjs2263@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Jung-Taek Hwang, MD, PhD | Hallym University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chuncheon Sacred Heart Hospital | Recruiting | Chuncheon | Gangwon-do | 24253 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34823312 | Result | Shim BJ, Seo EM, Hwang JT, Kim DY, Yang JS, Seo SJ, Hong MS. Comparison of the effectiveness of extensor muscle strengthening exercise by itself, exercise with polydeoxyribonucleotide injection, and exercise with extracorporeal shockwave therapy in lateral epicondylitis: a randomized controlled trial. Clin Shoulder Elb. 2021 Dec;24(4):231-238. doi: 10.5397/cise.2021.00290. Epub 2021 Nov 26. |
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Our IRB does not permit
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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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
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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
|
| 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 |
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |