Clinical trial NCT06055491: Vitamin D3 Combined With Strengthening Exercise for Lateral Epicondylitis of Elbow
Official title: Effect of Vitamin D3 Combined With Extensor Muscle Strengthening Exercise in Lateral Epicondylitis of Elbow: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lateral Epicondylitis of Elbow
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
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: visual analog scale of pain (VAS)
timeFrame: initial, Week 4, 12, 24
Secondary outcomes:
measure: Patient's satisfaction
timeFrame: initial, Week 4, 12, 24
measure: Mayo Elbow Performance Score (MEPS)
timeFrame: initial, Week 4, 12, 24
measure: Grip power (attected/nonaffected)
timeFrame: initial, Week 4, 12, 24
measure: plasma Vitamin D level
timeFrame: initial, Week 4, 12, 24
measure: sonographic evaluation
timeFrame: initial, Week 4, 12, 24
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
state: Gangwon
Study officials:
affiliation: Hallym University Medical Center
name: Jung-Taek Hwang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.