Action Mechanisms of Shock Waves on Pain

Not Applicable

Completed

• Conditions: Asymptomatic Condition
• Interventions: Other: Experimental Intervention; Other: Sham Comparator; Other: Control Group

• Registration Number: NCT03455933
• Lead Sponsor: Centro Universitario La Salle

Brief Summary

The aim of this study is to evaluate whether the intensity of pain perceived during the application of extracorporeal shockwave therapy (ESWT) is determinant for producing changes in pressure pain threshold (PPT) in asymptomatic subjects. The investigators will perform a single controlled random trial to three groups. Two of them will receive ESWT whereas the third group will get a cold pressure test (CPT).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-07
• Study Start: 2018-05-07
• Primary Completion: 2018-05-22
• Study Completion: 2018-05-22
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-06
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Absence of pain or illness
• No changes in cognitive ability
• Good command of Spanish, both spoken and written

Exclusion Criteria

• People with systemic diseases, tumors, infections, pacemakers, clotting disorders, skeletally immature, fibromyalgia, whiplash history, dizziness or in physiotherapeutic or pharmacological treatment
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shockwave Moderate Pain Group	Experimental Intervention	Experimental Intervention. It will received a moderate intensity shockwave in the lateral epicondyle regulated until reach a 6/10 in the Visual Analog Scale (VAS) scale.
Shockwave Light Pain Group	Sham Comparator	Sham Comparator. It will received a light intensity shockwave in the lateral epicondyle regulated until reach a 3/10 in the Visual Analog Scale (VAS) scale.
Cold Pressure Group	Control Group	Control Group. The cold pressure test will be apply to this group. The investigators will use a container with an outer part filled with ice and an inner part filled with water, both separated by a screen that prevents direct contact between the ice and the hand. The water will be regularly stirred to maintain the temperature near to 0.7ºC.

Primary Outcome Measures

Name	Time	Method
Pressure pain threshold	through study completion, an average of 1 month	The investigators will use a digital algometer (Force Ten FDX Wagner) to measure when pressure becomes pain.

Trial Locations

Locations (1)

CSEU La Salle Madrid; 🇪🇸 Madrid, Spain