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NCT Number: NCT05142852

Shock Wave Therapy in Individuals With Lateral Epicondylitis

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.

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Key information

Conditions

Lateral Epicondylitis Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isra University

Amman, 11622, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal Shock Wave Therapy

Device

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

Conventional Physiotherapy

Other

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

Primary outcomes

  1. Visual Analog Scale

    Time frame: Change from baseline Visual Analog Scale at 5 day

    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).

Secondary outcomes

  1. Upper extremity disability and symptoms

    Time frame: Change from baseline Upper extremity disability and symptoms at 5 day

    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.

  2. Maximal grip strength

    Time frame: Change from baseline maximal grip strength at 5 day

    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.

Sponsors and collaborators

Lead sponsor

Salameh Aldaja

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 3, 2021
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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