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Vitamin D3 Combined With Strengthening Exercise for Lateral Epicondylitis of Elbow

Primary Purpose

Lateral Epicondylitis of Elbow

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Vitamin D3 or Saline injection at ipsilateral deltoid muscle

About this trial

This is an interventional treatment trial for Lateral Epicondylitis of Elbow focused on measuring 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

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chuncheon Sacred Heart HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D3 injection

Saline injection

Arm Description

1.0mL Vitamin D3 injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counter force brace in lateral epicondylitis of elbow

1.0mL saline injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counter force brace in lateral epicondylitis of elbow

Outcomes

Primary Outcome Measures

visual analog scale of pain (VAS)

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

Secondary Outcome Measures

Patient's satisfaction

0-10, 0: not satisfied, 10: very much satisfied

Mayo Elbow Performance Score (MEPS)

0-100: higher score mean a better outcome

Grip power (attected/nonaffected)

Newton/Newton

plasma Vitamin D level

ng/mL

sonographic evaluation

common extensor

Full Information

NCT ID

NCT06055491

First Posted

September 15, 2023

Last Updated

October 3, 2023

Sponsor

Chuncheon Sacred Heart Hospital

1. Study Identification

Unique Protocol Identification Number

NCT06055491

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 25, 2023 (Actual)

Primary Completion Date

September 20, 2025 (Anticipated)

Study Completion Date

February 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chuncheon Sacred Heart Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D3 injection

Arm Type

Experimental

Arm Description

1.0mL Vitamin D3 injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counter force brace in lateral epicondylitis of elbow

Arm Title

Saline injection

Arm Type

Placebo Comparator

Arm Description

1.0mL saline injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counter force brace in lateral epicondylitis of elbow

Intervention Type

Drug

Intervention Name(s)

Vitamin D3 or Saline injection at ipsilateral deltoid muscle

Other Intervention Name(s)

extensor muscle strengthening exercise with counterforce brace

Intervention Description

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

Primary Outcome Measure Information:

Title

visual analog scale of pain (VAS)

Description

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

Time Frame

initial, Week 4, 12, 24

Secondary Outcome Measure Information:

Title

Patient's satisfaction

Description

0-10, 0: not satisfied, 10: very much satisfied

Time Frame

initial, Week 4, 12, 24

Title

Mayo Elbow Performance Score (MEPS)

Description

0-100: higher score mean a better outcome

Time Frame

initial, Week 4, 12, 24

Title

Grip power (attected/nonaffected)

Description

Newton/Newton

Time Frame

initial, Week 4, 12, 24

Title

plasma Vitamin D level

Description

ng/mL

Time Frame

initial, Week 4, 12, 24

Title

sonographic evaluation

Description

common extensor

Time Frame

initial, Week 4, 12, 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jung-Taek Hwang, MD, PhD

Phone

+82332405197

DRAKEHJT@HANMAIL.NET

First Name & Middle Initial & Last Name or Official Title & Degree

Ju Sun Kim

Phone

+332405198

wntjs2263@naver.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jung-Taek Hwang, MD, PhD

Organizational Affiliation

Hallym University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chuncheon Sacred Heart Hospital

City

Chuncheon

State/Province

Gangwon

ZIP/Postal Code

24253

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jung-Taek Hwang, MD, PhD

Phone

+82332405197

DRAKEHJT@HANMAIL.NET

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Our IRB does not permit

Citations:

PubMed Identifier

34823312

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.

Results Reference

result

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Vitamin D3 Combined With Strengthening Exercise for Lateral Epicondylitis of Elbow

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