Shock Wave Therapy in Individuals With Lateral Epicondylitis

NCT05142852 | Completed DMC

• 1 other identifier: 17/173
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lateral Epicondylitis

Keywords

Pain; Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Upper extremity disability and symptoms

  Change from baseline Upper extremity disability and symptoms at 5 day

• Maximal grip strength

  Change from baseline maximal grip strength at 5 day

Study Arms (2)

Extracorporeal shock wave therapy

EXPERIMENTAL

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

Conventional physiotherapy

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Shock wave

Extracorporeal shock wave therapy

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.

Also known as: Physiotherapy

Conventional physiotherapy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Salameh Aldaja: lead

Study Sites (1)

Isra University

Amman, 11622, Jordan

Location

MeSH Terms

Conditions

Tennis Elbow; Pain

Interventions

Extracorporeal Shockwave Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Rehabilitation

Study Officials

• Salameh Aldaja, PhD

  Isra University, Jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 3, 2021
• Study Start: June 5, 2021
• Primary Completion: August 28, 2021
• Study Completion: September 4, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-09

Locations

JO (1)