Lateral Epicondylitis, Extracorporeal Shockwave Therapy, Muscle Strengthening
Conditions
Keywords
Polydeoxyribonucleotide
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
Interventions
BEHAVIORALExtensor Muscle Strengthening Exercise
A series of exercises aimed at strengthening the extensor muscles of the forearm to alleviate symptoms of lateral epicondylitis.
PROCEDUREExtracorporeal Shockwave Therapy
A non-invasive procedure that uses shockwaves to promote healing and reduce pain in the affected area.
A 3mL injection of saline solution used as a placebo in the study.
DRUGPolydeoxyribonucleotide Injection
A 3mL injection of polydeoxyribonucleotide (5.625mg/3mL) used to enhance the healing process and improve outcomes in lateral epicondylitis treatment.
Sponsors
Chuncheon Sacred Heart Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Reduction | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional Improvement | Baseline, 6 weeks, 12 weeks | 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. |
| Grip Strength Improvement | Baseline, 6 weeks, 12 weeks | 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. |
| Common Extensor Tendon Depth Measured by Ultrasonography | Baseline, 6 weeks, 12 weeks | 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. |
| Color Doppler Activity Measured by Ultrasonography | Baseline, 6 weeks, 12 weeks | 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 |
Countries
South Korea
Outcome results
None listed