Action Mechanisms of Shock Waves on Pain

NCT03455933 | Completed

• 1 other identifier: CSEU La Salle
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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).

Conditions

Asymptomatic Condition

Outcome Measures

Primary Outcomes (1)

• Pressure pain threshold

  The investigators will use a digital algometer (Force Ten FDX Wagner) to measure when pressure becomes pain.

  through study completion, an average of 1 month

Other Outcomes (3)

• Pain Catastrophizing

  Baseline

• Kinesiophobia level

  Baseline

• Pain intensity

  During the intervention

Study Arms (3)

Shockwave Light Pain Group

EXPERIMENTAL

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.

Other: Sham Comparator

Shockwave Moderate Pain Group

EXPERIMENTAL

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.

Other: Experimental Intervention

Cold Pressure Group

OTHER

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.

Other: Control Group

Interventions

Sham Comparator OTHER

The investigators will apply a light intensity shockwave in the lateral epicondyle with the portable SHOCKMASTER 300 at a 8Hz frequency and 2000 impulses. The intensity will be regulated to reach a 3/10 in the VAS scale, depending on the tolerance of the subject. Each patient will receive between 5 and 10 impulses starting with the lower intensity of the device (middle energy: 1 bar) and will go up towards the target (3/10 in VAS).

Shockwave Light Pain Group

Experimental Intervention OTHER

The investigators will apply a moderate intensity shockwave in the lateral epicondyle with the portable SHOCKMASTER 300 at a 8Hz frequency and 2000 impulses. The intensity will be regulated to reach a 6/10 in the VAS scale, depending on the tolerance of the subject. Each patient will receive between 5 and 10 impulses starting with the lower intensity of the device (middle energy: 1 bar) and will go up towards the target (6/10 in VAS).

Shockwave Moderate Pain Group

Control Group OTHER

Patients will place their hand, wide open and up to the wrist, into the inner part of the container and will keep it under water for a maximum time of 2 minutes. If pain is unbearable before the time ends, the participant will be able to withdraw the hand.

Cold Pressure Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centro Universitario La Salle: lead

Study Sites (1)

CSEU La Salle Madrid

Madrid, 28008, Spain

Location

Related Publications (1)

• Garcia-Muntion A, Godefroy L, Robert H, Munoz-Garcia D, Calvo-Lobo C, Lopez-de-Uralde-Villanueva I. Study of the mechanisms of action of the hypoalgesic effect of pressure under shock waves application: A randomised controlled trial. Complement Ther Med. 2019 Feb;42:332-339. doi: 10.1016/j.ctim.2018.12.012. Epub 2018 Dec 18.

  PMID: 30670263 DERIVED

MeSH Terms

Conditions

Asymptomatic Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ibai Lopez de Uralde Villanueva

  Universidad La Salle, Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor and Principal Investigator

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: March 7, 2018
• Study Start: May 7, 2018
• Primary Completion: May 22, 2018
• Study Completion: May 22, 2018
• Last Updated: June 8, 2018

Record last verified: 2018-06

Locations

ES (1)