Shock Wave Therapy in Individuals With Lateral Epicondylitis

Analgesic Effect of Extracorporeal Shock Wave Therapy in Individuals With Lateral Epicondylitis: A Randomized Controlled Trial

A sample of 40 patients poststroke (24 males) was randomly allocated to either ESWT experimental (n=18) or conventional physiotherapy control group (n=20). All patients received 5 sessions during the treatment program. The Visual Analog Scale (VAS) and Taiwan version Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, and dynamometer (Maximal grip strength) for each participant were assessed before and after the treatment program.

Study Overview

• Status: Completed
• Conditions: Lateral Epicondylitis
• Intervention / Treatment: Device: Extracorporeal shock wave therapy; Other: Conventional physiotherapy

Detailed Description

The participants in the experiment group received 5 consecutive sessions of ESWT for 5 minutes. Treatment parameters for the shock wave therapy group were set similar to a previous study (Devrimsel et al., 2013) 2000 shock waves with 1.6 bar intensity and 16 Hz frequency were applied for five sessions using the Swiss DolorClast Master (EMS, Nyon, Switzerland). The participants in the control group received 5 sessions of conventional physical therapy intervention for 5 minutes. The control group intervention consists of a 1-minute friction massage over the common extensor tendon of the elbow, followed by 3 minutes therapeutic ultrasound with a frequency of 1.5 Hz, and a 1-minute ice massage over the common extensor tendon of the elbow. All participants used 10-cm lateral epicondyle bandages in the treatment period, while none of them received analgesic or anti-inflammatory drugs and received exercise programs.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11622
    • Isra University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• An inclusion criterion was a confirmed diagnosis of lateral epicondylitis with lateral elbow pain lasting more than 6 months and less than 1 year.

Exclusion Criteria:

• Participants were excluded from this study if they had cervical radiculopathy, elbow deformity, history of diabetes mellitus, hypo- or hyperthyroidism, history of malignancy, chronic inflammatory diseases, and pregnancy. Patients who received corticosteroid injections to the lateral epicondyle within 6 weeks were also excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extracorporeal shock wave therapy; The participants in the experiment group received 5 consecutive sessions of ESWT for 5 minutes. Treatment parameters for the shock wave therapy group were set similar to a previous study (Devrimsel et al., 2013) 2000 shock waves with 1.6 bar intensity and 16 Hz frequency were applied for five sessions using the Swiss DolorClast Master (EMS, Nyon, Switzerland). All participants used 10-cm lateral epicondyle bandages in the treatment period, while none of them received analgesic or anti-inflammatory drugs and received exercise programs.	Device: Extracorporeal shock wave therapy; The participants in the experiment group received 5 consecutive sessions of ESWT for 5 minutes. Treatment parameters for the shock wave therapy group were set similar to a previous study (Devrimsel et al., 2013) 2000 shock waves with 1.6 bar intensity and 16 Hz frequency were applied for five sessions using the Swiss DolorClast Master (EMS, Nyon, Switzerland). All participants used 10-cm lateral epicondyle bandages in the treatment period, while none of them received analgesic or anti-inflammatory drugs and received exercise programs.; Other Names: Shock wave
Active Comparator: Conventional physiotherapy; The participants in the control group received 5 sessions of conventional physical therapy intervention for 5 minutes. The control group intervention consists of a 1-minute friction massage over the common extensor tendon of the elbow, followed by 3 minutes therapeutic ultrasound with a frequency of 1.5 Hz, and a 1-minute ice massage over the common extensor tendon of the elbow. All participants used 10-cm lateral epicondyle bandages in the treatment period, while none of them received analgesic or anti-inflammatory drugs and received exercise programs.	Other: Conventional physiotherapy; The participants in the control group received 5 sessions of conventional physical therapy intervention for 5 minutes. The control group intervention consists of a 1-minute friction massage over the common extensor tendon of the elbow, followed by 3 minutes therapeutic ultrasound with a frequency of 1.5 Hz, and a 1-minute ice massage over the common extensor tendon of the elbow. All participants used 10-cm lateral epicondyle bandages in the treatment period, while none of them received analgesic or anti-inflammatory drugs and received exercise programs.; Other Names: Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	Participants were asked to rate their present pain intensity, as caused by the lateral epicondylitis, from zero to 10 using the Visual Analog Scale (VAS).	Change from baseline Visual Analog Scale at 5 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper extremity disability and symptoms	Upper extremity disability and symptoms were evaluated using the Taiwan version Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire (Khoury, 2009). This 30-item questionnaire asks about the participants' ability to perform 21 various tasks, includes nine questions associated with symptoms on a 5-point scale, with the score of one representing no difficulty or no symptom and the score of five representing the inability to finish the task or severe pain.	Change from baseline Upper extremity disability and symptoms at 5 day
Maximal grip strength	The maximal grip strength of the involved arm was evaluated using a grip strength dynamometer (Exacta Hydraulic Hand Dynamometer, North Coast Medical Inc, Gilroy, CA). Participants were asked to grip the dynamometer as hard as possible three times at 10-second rest intervals in the sitting position, with 90 degrees of elbow flexion, the shoulder in adduction, the wrist in slight extension, and the forearm in neutral position. The highest grip strength number was recorded.	Change from baseline maximal grip strength at 5 day

Collaborators and Investigators

• Sponsor: Salameh Aldaja
• Investigators: Principal Investigator: Salameh Aldaja, PhD, Isra University, Jordan

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2021
• Primary Completion (Actual): August 28, 2021
• Study Completion (Actual): September 4, 2021

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Function
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: 17/173

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No