Lateral EpicondylitisNCT06753630
Polydeoxyribonucleotide for Elbow Lateral Epicondylitis
A study testing Extensor Muscle Strengthening Exercise, Extracorporeal Shockwave Therapy and Polydeoxyribonucleotide Injection in people with Lateral Epicondylitis and Extracorporeal Shockwave Therapy, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to investigate the synergistic effect of polydeoxyribonucleotide (PDRN) on extensor muscle strengthening exercise (EMSE) combined with extracorporeal shockwave therapy (ESWT) for treating lateral epicondylitis (LE) of the elbow in adults aged 18 to 65 years. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis, Extracorporeal Shockwave Therapy, Muscle Strengthening
- What is being tested?
- Extensor Muscle Strengthening Exercise, Extracorporeal Shockwave Therapy and Polydeoxyribonucleotide Injection
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Nov 2014to 30 Nov 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years Diagnosed with chronic lateral epicondylitis (LE) of the elbow Willing to perform extensor muscle strengthening exercises Able to attend follow-up visits at 6 and 12 weeks
Who cannot join
- History of elbow surgery Significant trauma to the elbow Current use of corticosteroids for LE Current use of other treatments for LE Pregnant or breastfeeding women Participation in another clinical trial within the last 30 days
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 24253
About this study
Official title: Does Combined Polydeoxyribonucleotide Improve the Outcome of Extensor Muscle Strengthening Exercise with Extracorporeal Shockwave Therapy for Lateral Epicondylitis of Elbow?: a Randomized Controlled Trial
The goal of this clinical trial is to investigate the synergistic effect of polydeoxyribonucleotide (PDRN) on extensor muscle strengthening exercise (EMSE) combined with extracorporeal shockwave therapy (ESWT) for treating lateral epicondylitis (LE) of the elbow in adults aged 18 to 65 years. The main questions it aims to answer are:
Does the addition of PDRN improve pain reduction as measured by the Visual Analog Scale (VAS)? Does the addition of PDRN enhance functional outcomes such as the Mayo Elbow Performance Score (MEPS) and Hand Grip Strength Index (HGSI)?
Read more
Researchers will compare two groups to see if PDRN provides additional benefits:
Group 1: EMSE + ESWT + saline injection Group 2: EMSE + ESWT + PDRN injection
Participants will:
Perform extensor muscle strengthening exercises Receive extracorporeal shockwave therapy Receive either a saline injection or a PDRN injection at the first outpatient department visit Attend follow-up visits at 6 and 12 weeks for assessments
- Being tested
- Extensor Muscle Strengthening Exercise, Extracorporeal Shockwave Therapy, Saline injection (Octreotide LAR placebo), Polydeoxyribonucleotide Injection
- Keywords
- Polydeoxyribonucleotide
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extensor Muscle Strengthening ExerciseBehavioural
A series of exercises aimed at strengthening the extensor muscles of the forearm to alleviate symptoms of lateral epicondylitis.
Extracorporeal Shockwave TherapyProcedure or surgery
A non-invasive procedure that uses shockwaves to promote healing and reduce pain in the affected area.
Saline injection (Octreotide LAR placebo)Drug
A 3mL injection of saline solution used as a placebo in the study.
Polydeoxyribonucleotide InjectionDrug
A 3mL injection of polydeoxyribonucleotide (5.625mg/3mL) used to enhance the healing process and improve outcomes in lateral epicondylitis treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (G1): EMSE + ESWT + Saline Injection | Placebo comparator | Participants in this group will perform extensor muscle strengthening exercises and receive extracorporeal shockwave therapy. Additionally, they will receive a 3mL saline injection at the first outpatient department visit. Receives: Behavioral: Extensor Muscle Strengthening Exercise; Procedure: Extracorporeal Shockwave Therapy; Drug: Saline injection (Octreotide LAR placebo) |
| Group 2 (G2): EMSE + ESWT + PDRN Injection | Experimental | Participants in this group will perform extensor muscle strengthening exercises and receive extracorporeal shockwave therapy. Additionally, they will receive a 3mL injection of polydeoxyribonucleotide (PDRN) at the first outpatient department visit. Receives: Behavioral: Extensor Muscle Strengthening Exercise; Procedure: Extracorporeal Shockwave Therapy; Drug: Polydeoxyribonucleotide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reduction
Pain Reduction as measured by the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse pain.
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (4)
Functional Improvement
Improvement in elbow function as measured by the Mayo Elbow Performance Score (MEPS). This score ranges from 0 to 100, with higher scores indicating better elbow function. The MEPS assesses pain, range of motion, stability, and daily function.
Measured: Baseline, 6 weeks, 12 weeks
Grip Strength Improvement
Increase in hand grip strength as measured by the Hand Grip Strength Index (HGSI). HGSI is calculated as the ratio of affected side hand grip strength (in Newtons, N) to unaffected side hand grip strength (in Newtons, N). The index does not have predefined minimum or maximum values, as it is a relative measure. Higher values indicate greater improvement in grip strength on the affected side relative to the unaffected side.
Measured: Baseline, 6 weeks, 12 weeks
Common Extensor Tendon Depth Measured by Ultrasonography
Common Extensor Tendon Depth (CETD): Changes in common extensor tendon depth (units: millimeters, mm) as measured by ultrasonography. This measure assesses the structural changes in the tendon.
Measured: Baseline, 6 weeks, 12 weeks
Color Doppler Activity Measured by Ultrasonography
Color Doppler Activity (CDA): Changes in color Doppler activity as measured by ultrasonography. This measure assesses the vascular changes in the tendon.
Changes in CDA as measured by ultrasonography. CDA was graded on a scale from 0 to 4 within a 0.5-cm longitudinal part of the tendon with maximal Doppler activity. The grading criteria are as follows:
- Grade 0: No activity
- Grade 1: Single vessel in the region of interest (ROI)
- Grade 2: <25% of the ROI
- Grade 3: 25%-50% of the ROI
- Grade 4: >50% of the ROI
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start20 Nov 2014
- Primary completion30 Nov 2015
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753630
- Sponsor's protocol ID
- 2014-100
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Combined Polydeoxyribonucleotide Improve the Outcome of Extensor Muscle Strengthening Exercise with Extracorporeal Shockwave Therapy for Lateral Epicondylitis of Elbow?: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06753630
- Acronym / sponsor ID
- 2014-100
- Keywords
- Polydeoxyribonucleotide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- 20 Nov 2014 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 31 Dec 2024 (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 clinical trial is to investigate the synergistic effect of polydeoxyribonucleotide (PDRN) on extensor muscle strengthening exercise (EMSE) combined with extracorporeal shockwave therapy (ESWT) for treating lateral epicondylitis (LE) of the elbow in adults aged 18 to 65 years. The main questions it aims to answer are:
Does the addition of PDRN improve pain reduction as measured by the Visual Analog Scale (VAS)? Does the addition of PDRN enhance functional outcomes such as the Mayo Elbow Performance Score (MEPS) and Hand Grip Strength Index (HGSI)?
Researchers will compare two groups to see if PDRN provides additional benefits:
Group 1: EMSE + ESWT + saline injection Group 2: EMSE + ESWT + PDRN injection
Participants will:
Perform extensor muscle strengthening exercises Receive extracorporeal shockwave therapy Receive either a saline injection or a PDRN injection at the first outpatient department visit Attend follow-up visits at 6 and 12 weeks for assessments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (G1): EMSE + ESWT + Saline Injection | Placebo comparator | Behavioral: Extensor Muscle Strengthening Exercise, Procedure: Extracorporeal Shockwave Therapy, Drug: Saline injection (Octreotide LAR placebo)Participants in this group will perform extensor muscle strengthening exercises and receive extracorporeal shockwave therapy. Additionally, they will receive a 3mL saline injection at the first outpatient department visit. |
| Group 2 (G2): EMSE + ESWT + PDRN Injection | Experimental | Behavioral: Extensor Muscle Strengthening Exercise, Procedure: Extracorporeal Shockwave Therapy, Drug: Polydeoxyribonucleotide InjectionParticipants in this group will perform extensor muscle strengthening exercises and receive extracorporeal shockwave therapy. Additionally, they will receive a 3mL injection of polydeoxyribonucleotide (PDRN) at the first outpatient department visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 to 65 years Diagnosed with chronic lateral epicondylitis (LE) of the elbow Willing to perform extensor muscle strengthening exercises Able to attend follow-up visits at 6 and 12 weeks
Key exclusion criteria (1 listed)
- History of elbow surgery Significant trauma to the elbow Current use of corticosteroids for LE Current use of other treatments for LE Pregnant or breastfeeding women Participation in another clinical trial within the last 30 days
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 |
|---|---|---|
| Extensor Muscle Strengthening ExerciseA series of exercises aimed at strengthening the extensor muscles of the forearm to alleviate symptoms of lateral epicondylitis. | Behavioural | Group 1 (G1): EMSE + ESWT + Saline Injection, Group 2 (G2): EMSE + ESWT + PDRN Injection |
| Extracorporeal Shockwave TherapyA non-invasive procedure that uses shockwaves to promote healing and reduce pain in the affected area. | Procedure or surgery | Group 1 (G1): EMSE + ESWT + Saline Injection, Group 2 (G2): EMSE + ESWT + PDRN Injection |
| Saline injection (Octreotide LAR placebo)A 3mL injection of saline solution used as a placebo in the study. | Drug | Group 1 (G1): EMSE + ESWT + Saline Injection |
| Polydeoxyribonucleotide InjectionA 3mL injection of polydeoxyribonucleotide (5.625mg/3mL) used to enhance the healing process and improve outcomes in lateral epicondylitis treatment. | Drug | Group 2 (G2): EMSE + ESWT + PDRN Injection |
Primary outcome
Pain Reduction
Time frame: Baseline, 6 weeks, 12 weeks
Pain Reduction as measured by the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse pain.
4 secondary outcomes
Functional Improvement
Time frame: Baseline, 6 weeks, 12 weeks
Grip Strength Improvement
Time frame: Baseline, 6 weeks, 12 weeks
Common Extensor Tendon Depth Measured by Ultrasonography
Time frame: Baseline, 6 weeks, 12 weeks
Color Doppler Activity Measured by Ultrasonography
Time frame: Baseline, 6 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extensor Muscle Strengthening Exercise, Extracorporeal Shockwave Therapy and Polydeoxyribonucleotide Injection in people with Lateral Epicondylitis and Extracorporeal Shockwave Therapy, 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 1 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: finished, as of the sponsor's last update on 31 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Reduction (time frame: Baseline, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2024.