Vitamin D3 Combined With Strengthening Exercise for Lateral Epicondylitis of Elbow

October 3, 2023 updated by: Jung-Taek Hwang, Chuncheon Sacred Heart Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gangwon
      • Chuncheon, Gangwon, Korea, Republic of, 24253
        • Recruiting
        • Chuncheon Sacred Heart Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D3 injection
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
study group: 1.0mL Vitamin D3 injection control group: 1.0mL saline injection
Other Names:
  • extensor muscle strengthening exercise with counterforce brace
Placebo Comparator: Saline injection
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
study group: 1.0mL Vitamin D3 injection control group: 1.0mL saline injection
Other Names:
  • extensor muscle strengthening exercise with counterforce brace

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chuncheon Sacred Heart Hospital

Investigators

  • Principal Investigator: Jung-Taek Hwang, MD, PhD, Hallym University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Estimated)

September 20, 2025

Study Completion (Estimated)

February 20, 2026

Study Registration Dates

First Submitted

September 15, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-07-018-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Our IRB does not permit

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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