Lateral Epicondylitis
Conditions
Keywords
Lateral Epicondylitis, Extracorporeal Shock Wave Therapy, ESWT, Pulsed Electromagnetic Field Therapy, PEMF, Patient-Rated Tennis Elbow Evaluation
Brief summary
This randomized, sham-controlled, assessor-blinded clinical trial will evaluate the efficacy of pulsed electromagnetic field therapy (PEMF) added to extracorporeal shock wave therapy (ESWT) in adults with lateral epicondylitis. A total of 70 participants will be randomly assigned to receive either ESWT plus active PEMF or ESWT plus sham PEMF. Both groups will also receive the same standardized home exercise program. Treatment will be administered once weekly for 5 weeks. Participants will be assessed before treatment, at the end of the 5-week treatment period, and 3 months after treatment. The primary outcome will be the Patient-Rated Tennis Elbow Evaluation (PRTEE) total score. Secondary outcomes will include pain intensity measured using the Numeric Rating Scale, pressure pain threshold, maximum and pain-free grip strength, and ultrasonographic assessment of the common extensor tendon, including tendon thickness, hypoechogenicity, and fibrillar pattern abnormalities.
Interventions
Active pulsed electromagnetic field therapy will be applied before each ESWT session for 30 minutes, once weekly for 5 weeks. According to the study protocol, PEMF will be delivered at 25 Hz and 4.6 Hz sequentially, with a total of 6 mT per session.
Sham PEMF will be applied before ESWT using the same duration and positioning as active PEMF. The device will have the same appearance, sound, and light signals as the active device but will not generate a therapeutic electromagnetic field.
DEVICEExtracorporeal Shock Wave Therapy
Extracorporeal shock wave therapy will be applied to the point of maximum tenderness over the lateral epicondyle using 2000 shocks per session at 1.5-2.0 bar and 10 Hz, once weekly for 5 weeks. Transmission gel will be used and local anesthesia will not be administered.
BEHAVIORALHome Exercise Program
All participants will receive the same standardized home exercise program. The program will include eccentric wrist extension (3 sets of 15 repetitions once daily), isometric wrist extension (3 sets of 30-second contractions once daily), and static stretching exercises targeting the forearm flexor and extensor muscle groups (3 sets of 30-second holds twice daily). The exercises will be demonstrated individually at the first session and supported with a written and visual exercise brochure. Exercise adherence will be checked and recorded weekly before each treatment session.
Sponsors
Ali Güneri
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be blinded to active or sham PEMF allocation. The sham device will provide the same appearance, sound, and light signals as the active device but will not generate a therapeutic electromagnetic field. Outcome assessments will be performed by assessors who are unaware of group allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 65 years * Symptom duration of at least 3 months * Clinical diagnosis of unilateral lateral epicondylitis * Numeric Rating Scale (NRS) pain score of at least 4 * Ability and willingness to provide written informed consent
Exclusion criteria
* Injection treatment, including corticosteroid or platelet-rich plasma (PRP), within the previous 6 months * Previous application of physical therapy modalities to the affected region * Cervical radiculopathy, peripheral nerve entrapment neuropathy, or another neurological condition that may mimic lateral elbow pain * Uncontrolled diabetes mellitus, defined as HbA1c \>8%, or the presence of diabetic peripheral neuropathy * Rheumatoid arthritis or other inflammatory rheumatic diseases * Previous surgery involving the affected elbow * Elbow instability, significant limitation of joint range of motion, extensor tendon rupture, or a history of major trauma to the elbow * Other shoulder or upper extremity disorders that may explain lateral elbow pain * Active infection or open wound at the treatment site * Malignancy * Presence of a pacemaker, defibrillator, electronic implant, or other active implanted device * Pregnancy * Coagulopathy or anticoagulant use * Inability to complete the questionnaires because of cognitive impairment or expected poor adherence to follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PRTEE Pain Subscale Score | Baseline, end of the 5-week treatment period, and 3 months after treatment completion | The PRTEE pain subscale consists of 5 items and ranges from 0 to 50, with higher scores indicating greater pain. |
| Change in PRTEE Function Subscale Score | Baseline, end of the 5-week treatment period, and 3 months after treatment completion | The PRTEE function subscale consists of 10 items and ranges from 0 to 50, with higher scores indicating greater functional impairment. |
| Change in Patient-Rated Tennis Elbow Evaluation (PRTEE) Total Score | Baseline, end of the 5-week treatment period, and 3 months after treatment completion | The PRTEE is a lateral epicondylitis-specific questionnaire consisting of a pain subscale and a function subscale. The total score ranges from 0 to 100, with higher scores indicating greater pain and functional impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Common Extensor Tendon Thickness | Baseline, end of the 5-week treatment period, and 3 months after treatment completion | Common extensor tendon thickness will be assessed by ultrasonography in the longitudinal plane at the lateral epicondyle origin. Maximum tendon thickness will be recorded in millimeters (mm). |
| Change in Common Extensor Tendon Hypoechogenicity | Baseline, end of the 5-week treatment period, and 3 months after treatment completion | The presence of hypoechoic areas within the common extensor tendon will be assessed by ultrasonography and recorded as present or absent. |
| Change in Common Extensor Tendon Fibrillar Pattern | Baseline, end of the 5-week treatment period, and 3 months after treatment completion | Abnormality of the fibrillar pattern of the common extensor tendon will be assessed by ultrasonography and recorded as present or absent. |
| Change in Pressure Pain Threshold | Baseline, end of the 5-week treatment period, and 3 months after treatment completion | Pressure pain threshold over the lateral epicondyle will be measured using a pressure algometer with a 1.0 cm² probe. Three measurements will be obtained and the mean value will be recorded in kg/cm². |
| Change in Pain Intensity Measured by the Numeric Rating Scale | Baseline, end of the 5-week treatment period, and 3 months after treatment completion | Pain intensity will be assessed using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. |
| Change in Maximum Grip Strength | Baseline, end of the 5-week treatment period, and 3 months after treatment completion | Maximum grip strength will be measured using a Jamar hydraulic hand dynamometer. Three measurements will be performed and the mean value will be recorded in kilograms (kg). |
| Change in Pain-Free Grip Strength | Baseline, end of the 5-week treatment period, and 3 months after treatment completion | Pain-free grip strength will be measured using a Jamar hydraulic hand dynamometer. Three measurements will be performed and the mean value will be recorded in kilograms (kg). |
Contacts
CONTACTAli Güneri, MD
CONTACTMerve Önoğul Özmen, MD
PRINCIPAL_INVESTIGATORAli Güneri, MD
Gaziantep City Hospital
Outcome results
None listed