Does Combined Polydeoxyribonucleotide Improve the Outcome of Extensor Muscle Strengthening Exercise with Extracorporeal Shockwave Therapy for Lateral Epicondylitis of Elbow?: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Chuncheon Sacred Heart Hospital
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Pain Reduction
Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Group 2 (G2): EMSE + ESWT + PDRN Injection
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.
Intervention: Extensor Muscle Strengthening Exercise (Behavioral)
Group 1 (G1): EMSE + ESWT + Saline Injection
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.
Intervention: Extensor Muscle Strengthening Exercise (Behavioral)
Group 1 (G1): EMSE + ESWT + Saline Injection
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.
Intervention: Extracorporeal Shockwave Therapy (Procedure)
Group 1 (G1): EMSE + ESWT + Saline Injection
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.
Intervention: Saline injection (Octreotide LAR placebo) (Drug)
Group 2 (G2): EMSE + ESWT + PDRN Injection
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.
Intervention: Extracorporeal Shockwave Therapy (Procedure)
Group 2 (G2): EMSE + ESWT + PDRN Injection
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.
Intervention: Polydeoxyribonucleotide Injection (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Functional Improvement(Baseline, 6 weeks, 12 weeks)
- Grip Strength Improvement(Baseline, 6 weeks, 12 weeks)
- Common Extensor Tendon Depth Measured by Ultrasonography(Baseline, 6 weeks, 12 weeks)
- Color Doppler Activity Measured by Ultrasonography(Baseline, 6 weeks, 12 weeks)
Investigators
Jung-Taek Hwang
Professor
Chuncheon Sacred Heart Hospital