ClinicalTrials.gg
Sign In
RecruitingNCT06055491Updated Oct 5, 2023

Vitamin D3 Combined With Strengthening Exercise for Lateral Epicondylitis of Elbow

An interventional study of Vitamin D3 or Saline injection at ipsilateral deltoid muscle in Lateral Epicondylitis of Elbow, sponsored by Chuncheon Sacred Heart Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by Chuncheon Sacred Heart Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lateral Epicondylitis of Elbow

Browse trials for

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
03

In context

Tennis Elbow

296 studies on the registry are indexed under Tennis Elbow; 64 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 262 interventional studies indexed under Tennis Elbow.

Browse Tennis Elbow studies →

Lead sponsor

Chuncheon Sacred Heart Hospital is the lead sponsor of 56 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugVitamin D3 or Saline injection at ipsilateral deltoid muscle

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

    Also known as: extensor muscle strengthening exercise with counterforce brace

06

What researchers measure

Primary outcomes

  1. visual analog scale of pain (VAS)

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

    Time frame: initial, Week 4, 12, 24

Secondary outcomes

  1. Patient's satisfaction

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

    Time frame: initial, Week 4, 12, 24

  2. Mayo Elbow Performance Score (MEPS)

    0-100: higher score mean a better outcome

    Time frame: initial, Week 4, 12, 24

  3. Grip power (attected/nonaffected)

    Newton/Newton

    Time frame: initial, Week 4, 12, 24

  4. plasma Vitamin D level

    ng/mL

    Time frame: initial, Week 4, 12, 24

  5. sonographic evaluation

    common extensor

    Time frame: initial, Week 4, 12, 24

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No — Our IRB does not permit

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Sep 2025, 23 months after the start.

Of 152 non-industry interventional studies with no phase under Tennis Elbow, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's planned 23 months is above that.

Counting every sponsor, half of 154 studies reached it within 8 months; a quarter within 5 and three quarters within 22.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2023
First posted
Sep 26, 2023
StartActual
Sep 25, 2023
Primary completionEst.
Sep 20, 2025
CompletionEst.
Feb 20, 2026
Last update
Oct 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06055491
Lead sponsor
Chuncheon Sacred Heart Hospital
Responsible party
Jung-Taek Hwang (Professor, Chuncheon Sacred Heart Hospital) — Principal investigator
First posted
Sep 26, 2023
Start date
Sep 25, 2023
Primary completion
Sep 20, 2025 (estimated)
Completion
Feb 20, 2026 (estimated)
Last update
Oct 5, 2023

Study contacts

Jung-Taek Hwang, MD, PhD
Contact
DRAKEHJT@HANMAIL.NET
+82332405197
Ju Sun Kim
Contact
wntjs2263@naver.com
+332405198
Jung-Taek Hwang, MD, PhD
principal investigator · Hallym University Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Tennis Elbow →

Other studies from this sponsor

Chuncheon Sacred Heart Hospital

Start the discussion