Vitamin D3 Combined With Strengthening Exercise for Lateral Epicondylitis of Elbow

NCT06055491 | Recruiting DMC

• 1 other identifier: 2023-07-018-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• visual analog scale of pain (VAS)

  0-10, 0: no pain, 10: very severe pain

  initial, Week 4, 12, 24

Secondary Outcomes (5)

• Patient's satisfaction

  initial, Week 4, 12, 24

• Mayo Elbow Performance Score (MEPS)

  initial, Week 4, 12, 24

• Grip power (attected/nonaffected)

  initial, Week 4, 12, 24

• plasma Vitamin D level

  initial, Week 4, 12, 24

• sonographic evaluation

  initial, Week 4, 12, 24

Study Arms (2)

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

Drug: Vitamin D3 or Saline injection at ipsilateral deltoid muscle

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

Drug: Vitamin D3 or Saline injection at ipsilateral deltoid muscle

Interventions

Vitamin D3 or Saline injection at ipsilateral deltoid muscle DRUG

study group: 1.0mL Vitamin D3 injection control group: 1.0mL saline injection

Also known as: extensor muscle strengthening exercise with counterforce brace

Saline injection; Vitamin D3 injection

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Study Sites (1)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 34823312 RESULT

MeSH Terms

Conditions

Tennis Elbow

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Jung-Taek Hwang, MD, PhD

  Hallym University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Taek Hwang, MD, PhD

CONTACT

+82332405197; DRAKEHJT@HANMAIL.NET

Ju Sun Kim

CONTACT

+332405198; wntjs2263@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 26, 2023
• Study Start: September 25, 2023
• Primary Completion: September 20, 2025
• Study Completion: February 20, 2026
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)