Shock Wave Therapy in Individuals With Lateral Epicondylitis

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05142852
• Other study ID #: 17/173
• Status: Completed
• Phase: N/A
• Start date: June 5, 2021
• Est. completion date: September 4, 2021

Study information

• Verified date: September 2021
• Source: Isra University, Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 4, 2021
• Est. primary completion date: August 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

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:
• 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.

Locations

Country	Name	City	State
Jordan	Isra University	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Salameh Aldaja

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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