Clinical trial NCT05334953: Efficacy of Extracorporeal Shock Wave Therapy, Ultrasound and Phonophoresis Treatments in Lateral Epicondylitis
Official title: Comparing the Efficacy of Extracorporeal Shock Wave Therapy, Ultrasound and Phonophoresis Treatments in Lateral Epicondylitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Keywords: lateral epicondylitis
extracorporeal shock wave therapy
ultrasound
phonophoresis
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study; to determine the effectiveness of ESWT, ultrasound and phonophoresis treatments on pain, grip strength, functionality and quality of life in patients with lateral epicondylitis and to determine the superiority of the treatments to each other.

Detailed description: Lateral epicondylitis is the most common cause of elbow lateral pain in adults. Pain that occurs in LE and radiates to the humerus and forearm is characteristic of this disease. The main complaints being pain and decreased grip strength, both of which may affect activities of daily living. The patient's complaints regress with rest,but but can increase again during daily activities such as grasping, repetitive hand movements, holding door handles, turning keys, lifting heavy loads. Diagnosis of lateral epicondylitis is largely based on clinical history and examination. Conservative treatment is the first line treatment. Generally, %90 of patients with LE benefit from conservative and medical treatment, and only a few need surgery. These treatment methods include many options such as activity modification, topical and oral NSAIDs, splinting, stretching and strengthening exercises, various injections, prolotherapy and electrotherapy modalities. Laser, TENS, ultrasound, phonophoresis, iontophoresis and ESWT are electrotherapeutic agents that can be used in therapy to relieve pain and promote healing. Research on physical treatments for LE has not yet proven superiority of one specific approach.

Although many studies have been done for ESWT, ultrasound and phonophoresis, there is not any study that compares these three modalities.In addition, there ara fewer studies about measuring the effect of these treatment methods which contain control groups. In this study, our aim is to investigate the efficacy of ESWT, ultrasound therapy and phonophoresis methods used in the treatment of LE and to compare the efficacy of these three treatments against each other and control group.

Eligibility criteria: Inclusion Criteria:

* Aged between 18-65 years
* Pain on the lateral side of the elbow for at least 4 weeks
* Tenderness over the lateral epicondyle
* Positive in at least two of the lateral epicondylitis spesific tests (Cozen test, Maudley test and Mills test)

Exclusion Criteria:

* Be younger than 18
* Having had ESWT treatment in the elbow area before
* History of injection, surgery, physical therapy in the elbow area in the last 3 months
* Previous elbow surgery
* History of radius/ulna fracture
* A history of cervical and shoulder problems
* having bilateral symptoms
* concomitant medial epicondylitis
* Malignancy
* Pregnancy
* Systemic rheumatologic disease or systemic infection
* inserted cardiac pacemaker
* presence of coagulation disorders
* Cognitive disfunction

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Change from Baseline at 1 month after treatment.
Secondary outcomes:
measure: Patient-Rated Tennis Elbow Evaluation (PRTEE) scales
timeFrame: Change from Baseline at 1 month after treatment.
measure: Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire score
timeFrame: Change from Baseline at 1 month after treatment.
measure: Roles and Maudsley Score
timeFrame: Change from Baseline at 1 month after treatment.
measure: Health Assessment Questionnaire (HAQ) score
timeFrame: Change from Baseline at 1 month after treatment.
measure: Grip Strength score
timeFrame: Change from Baseline at 1 month after treatment.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif university
Study officials:
affiliation: okan4494@yahoo.com
name: Okan Küçükakkaş, Doç
role: STUDY_DIRECTOR
affiliation: elifdemirbag92qgmail.com
name: Elif Uğurlu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yalvac B, Mesci N, Geler Kulcu D, Yurdakul OV. Comparison of ultrasound and extracorporeal shock wave therapy in lateral epicondylosis. Acta Orthop Traumatol Turc. 2018 Sep;52(5):357-362. doi: 10.1016/j.aott.2018.06.004. Epub 2018 Jun 28.
citation: Bayram K, Yesil H, Dogan E. Efficacy of extracorporeal shock wave therapy in the treatment of lateral epicondylitis. North Clin Istanb. 2014 Aug 3;1(1):33-38. doi: 10.14744/nci.2014.77487. eCollection 2014.
citation: Stasinopoulos D, Johnson MI. Cyriax physiotherapy for tennis elbow/lateral epicondylitis. Br J Sports Med. 2004 Dec;38(6):675-7. doi: 10.1136/bjsm.2004.013573.
citation: Weber C, Thai V, Neuheuser K, Groover K, Christ O. Efficacy of physical therapy for the treatment of lateral epicondylitis: a meta-analysis. BMC Musculoskelet Disord. 2015 Aug 25;16:223. doi: 10.1186/s12891-015-0665-4.