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Shock Wave Therapy in Individuals With Lateral Epicondylitis

Primary Purpose

Lateral Epicondylitis

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Extracorporeal shock wave therapy
Conventional physiotherapy
Sponsored by
Salameh Aldaja
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Pain, Function

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Isra University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extracorporeal shock wave therapy

Conventional physiotherapy

Arm 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). 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 22, 2021
Last Updated
November 22, 2021
Sponsor
Salameh Aldaja
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1. Study Identification

Unique Protocol Identification Number
NCT05142852
Brief Title
Shock Wave Therapy in Individuals With Lateral Epicondylitis
Official Title
Analgesic Effect of Extracorporeal Shock Wave Therapy in Individuals With Lateral Epicondylitis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 5, 2021 (Actual)
Primary Completion Date
August 28, 2021 (Actual)
Study Completion Date
September 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Salameh Aldaja

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
Pain, Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extracorporeal shock wave therapy
Arm Type
Experimental
Arm 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). 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.
Arm Title
Conventional physiotherapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Extracorporeal shock wave therapy
Other Intervention Name(s)
Shock wave
Intervention 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). 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.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Other Intervention Name(s)
Physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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).
Time Frame
Change from baseline Visual Analog Scale at 5 day
Secondary Outcome Measure Information:
Title
Upper extremity disability and symptoms
Description
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.
Time Frame
Change from baseline Upper extremity disability and symptoms at 5 day
Title
Maximal grip strength
Description
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.
Time Frame
Change from baseline maximal grip strength at 5 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salameh Aldaja, PhD
Organizational Affiliation
Isra University, Jordan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isra University
City
Amman
ZIP/Postal Code
11622
Country
Jordan

12. IPD Sharing Statement

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Shock Wave Therapy in Individuals With Lateral Epicondylitis

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