Lateral Epicondylitis of ElbowNCT06055491
Vitamin D3 Combined With Strengthening Exercise for Lateral Epicondylitis of Elbow
A study testing Vitamin D3 or Saline injection at ipsilateral deltoid muscle in people with Lateral Epicondylitis of Elbow, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lateral Epicondylitis of Elbow
- What is being tested?
- Vitamin D3 or Saline injection at ipsilateral deltoid muscle
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Sep 2023to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 24253
Jung-Taek Hwang, MD, PhD, +82332405197, DRAKEHJT@HANMAIL.NET
About this study
Official title: 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.
- Conditions
- Lateral Epicondylitis of Elbow
- Being tested
- Vitamin D3 or Saline injection at ipsilateral deltoid muscle
- 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
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 or Saline injection at ipsilateral deltoid muscleDrug
Also called extensor muscle strengthening exercise with counterforce brace
study group: 1.0mL Vitamin D3 injection control group: 1.0mL saline injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Vitamin D3 or Saline injection at ipsilateral deltoid muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale of pain (VAS)
0-10, 0: no pain, 10: very severe pain
Measured: initial, Week 4, 12, 24
Secondary outcomes (5)
Patient's satisfaction
0-10, 0: not satisfied, 10: very much satisfied
Measured: initial, Week 4, 12, 24
Mayo Elbow Performance Score (MEPS)
0-100: higher score mean a better outcome
Measured: initial, Week 4, 12, 24
Grip power (attected/nonaffected)
Newton/Newton
Measured: initial, Week 4, 12, 24
plasma Vitamin D level
ng/mL
Measured: initial, Week 4, 12, 24
sonographic evaluation
common extensor
Measured: initial, Week 4, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start25 Sep 2023
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lateral Epicondylitis of ElbowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Taek Hwang, Chuncheon Sacred Heart Hospital
- Investigators
- Jung-Taek Hwang, MD, PhD, Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055491
- Sponsor's protocol ID
- 2023-07-018-001
- Status last verified
- Oct 2023
- First submitted
- 15 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our IRB does not permit
Publications
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.
PubMed 34823312
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D3 Combined With Extensor Muscle Strengthening Exercise in Lateral Epicondylitis of Elbow: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06055491
- Acronym / sponsor ID
- 2023-07-018-001
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 injection | Experimental | Drug: Vitamin D3 or Saline injection at ipsilateral deltoid muscle1.0mL 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 | Drug: Vitamin D3 or Saline injection at ipsilateral deltoid muscle1.0mL saline injection at ilsilateral deltoid muscle and extensor muscle strengthening exercise with counter force brace in lateral epicondylitis of elbow |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 or Saline injection at ipsilateral deltoid muscleAlso: extensor muscle strengthening exercise with counterforce bracestudy group: 1.0mL Vitamin D3 injection control group: 1.0mL saline injection | Drug | Saline injection, Vitamin D3 injection |
Primary outcome
visual analog scale of pain (VAS)
Time frame: initial, Week 4, 12, 24
0-10, 0: no pain, 10: very severe pain
5 secondary outcomes
Patient's satisfaction
Time frame: initial, Week 4, 12, 24
Mayo Elbow Performance Score (MEPS)
Time frame: initial, Week 4, 12, 24
Grip power (attected/nonaffected)
Time frame: initial, Week 4, 12, 24
plasma Vitamin D level
Time frame: initial, Week 4, 12, 24
sonographic evaluation
Time frame: initial, Week 4, 12, 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Results publication: PubMed 34823312Shim 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.
- Individual participant dataSharing planned: No. Our IRB does not permit
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Taek Hwang, MD, PhD principal investigator
Hallym University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 or Saline injection at ipsilateral deltoid muscle in people with Lateral Epicondylitis of Elbow, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Taek Hwang, MD, PhD (+82332405197, DRAKEHJT@HANMAIL.NET), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale of pain (VAS) (time frame: initial, Week 4, 12, 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06055491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.