Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| KD24/04 | Other Identifier | Başkent University Clinical Research Ethics Committee |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized controlled study evaluates the effect of extracorporeal shock wave therapy applied to the extensor carpi radialis brevis trigger point in patients with lateral epicondylitis. Participants receive active extracorporeal shock wave therapy to the lateral epicondyle region. In addition, one group receives active extracorporeal shock wave therapy to the extensor carpi radialis brevis trigger point, while the other group receives sham extracorporeal shock wave therapy to the trigger point. Pain, grip strength, hand function, and common extensor tendon thickness are assessed before treatment and at week 4.
Lateral epicondylitis is a common tendinopathic condition characterized by pain over the lateral elbow, reduced grip strength, and limitation in upper extremity function. The extensor carpi radialis brevis tendon and the common extensor tendon origin are frequently involved. Myofascial trigger points in the extensor carpi radialis brevis muscle may also contribute to pain and functional impairment.
This prospective randomized controlled single-blind study investigates whether extracorporeal shock wave therapy applied to the extensor carpi radialis brevis trigger point provides additional clinical and ultrasonographic benefit in patients with lateral epicondylitis. Participants are allocated to two parallel groups. Both groups receive active extracorporeal shock wave therapy to the lateral epicondyle region once weekly for three sessions. The intervention group also receives active extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle. The comparator group receives sham extracorporeal shock wave therapy to the same trigger point area.
Outcome assessments are performed at baseline and at week 4. Pain intensity is assessed using the Visual Analog Scale. Grip strength is measured with a Jamar hand dynamometer. Hand function is assessed using the Duruöz Hand Index. Common extensor tendon thickness is measured by ultrasonography. The primary aim is to determine whether active trigger point extracorporeal shock wave therapy provides additional improvement compared with sham trigger point application when both groups receive active treatment to the lateral epicondyle region.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Trigger Point ESWT Group | Experimental | Participants receive active extracorporeal shock wave therapy to the lateral epicondyle region and active extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle, once weekly for three sessions. |
|
| Sham Trigger Point ESWT Group | Sham Comparator | Participants receive active extracorporeal shock wave therapy to the lateral epicondyle region and sham extracorporeal shock wave therapy to one trigger point in the extensor carpi radialis brevis muscle, once weekly for three sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal Shock Wave Therapy | Device | Active extracorporeal shock wave therapy is applied to the lateral epicondyle region in both groups once weekly for three sessions. In the experimental group, active extracorporeal shock wave therapy is also applied to one trigger point in the extensor carpi radialis brevis muscle. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Common Extensor Tendon Thickness | Common extensor tendon thickness is measured by ultrasonography using a linear probe with the elbow flexed at 90 degrees and the forearm in mid-supination. Measurements are performed on a longitudinal image at the lateral epicondyle region, perpendicular to the tendon fibers. The change from baseline to week 4 is evaluated | Baseline and week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity Assessed by Visual Analog Scale | Pain intensity is assessed using a 10-cm Visual Analog Scale. A score of 0 indicates no pain and a score of 10 indicates the worst pain. | Baseline and week 4 |
| Change in Grip Strength |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gazi University Faculty of Medicine Hospital | Ankara | Ankara | 06560 | Turkey (Türkiye) |
Individual participant data will not be shared due to privacy and ethical restrictions.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
Not provided
Not provided
Participants are randomized into two parallel groups. Both groups receive active extracorporeal shock wave therapy to the lateral epicondyle region. One group receives active extracorporeal shock wave therapy to the extensor carpi radialis brevis trigger point, while the other group receives sham extracorporeal shock wave therapy to the same trigger point area.
Not provided
Not provided
Participants were blinded to whether the trigger point extracorporeal shock wave therapy application was active or sham. The care provider administering the intervention was not blinded.
|
| Sham Extracorporeal Shock Wave Therapy | Device | Sham extracorporeal shock wave therapy is applied to one trigger point in the extensor carpi radialis brevis muscle using a sham applicator that produces a similar sound but does not deliver therapeutic shock wave energy. |
|
Grip strength is measured using a Jamar hand dynamometer. Measurements are performed with the participant seated, the shoulder adducted, the elbow flexed at 90 degrees, the forearm in neutral position, and the wrist in neutral position. Three consecutive measurements are obtained from the affected side, and the mean value is used for analysis. The change from baseline to week 4 is evaluated.
| Baseline and week 4 |
| Change in Functional Disability Assessed by the Duruöz Hand Index | functional disability is assessed using the Duruöz Hand Index. The scale includes 18 items evaluating difficulties in daily activities involving hand use. Total scores range from 0 to 90, with higher scores indicating greater disability. The change from baseline to week 4 is evaluated. | Baseline and week 4 |
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |