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Action Mechanisms of Shock Waves on Pain

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ClinicalTrials.gov Identifier: NCT03455933
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Ibai López de Uralde Villanueva, 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).

Condition or disease Intervention/treatment Phase
Asymptomatic Condition Other: Sham Comparator Other: Experimental Intervention Other: Control Group Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Action Mechanisms Responsibles for the Effects of Shock Waves on the Pressure Pain Thresholds
Actual Study Start Date : May 7, 2018
Actual Primary Completion Date : May 22, 2018
Actual Study Completion Date : May 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Shockwave Light Pain Group
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
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).

Experimental: Shockwave Moderate Pain Group
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
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).

Cold Pressure 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.
Other: Control Group
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.




Primary Outcome Measures :
  1. Pressure pain threshold [ Time Frame: 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.


Other Outcome Measures:
  1. Pain Catastrophizing [ Time Frame: Baseline ]
    The Spanish version of the Pain Catastrophizing Scale (PCS) assesses the degree of pain catastrophizing. It assess three components of catastrophizing: rumination, magnification, and helplessness. The PCS is composed of 13 items, which must be answered by a numeric value between 0 (not at all) and 4 (all the time), having a maximum score of 52 points (higher scores indicates more catastrophizing). PCS is a reliable and valid measure of pain catastrophizing (D'Eon JL, Harris CA, Ellis JA. Testing factorial validity and gender invariance of the pain catastrophizing scale. J Behav Med 2004; 27:361-372) (Olmedilla Zafra A, Ortega Toro E, Cano LA. Validation of the Pain Catastrophizing Scale in Spanish athletes. Cuad Psicol del Deport 2013; 13:83-93.).

  2. Kinesiophobia level [ Time Frame: Baseline ]
    Pain-related fear of movement was assessed using the 11-item Spanish version of the Tampa Scale of Kinesiophobia (TSK-11), whose reliability and validity have been demonstrated (Gómez-Pérez L, López-Martínez AE, Ruiz-Párraga GT. Psychometric properties of the Spanish version of the Tampa Scale for Kinesiophobia (TSK). J Pain 2011; 12:425-435.). Each item is scored using a 4-point scale (1 = strongly disagree; 4 = strongly agree). The final score can range between 11 and 44 points, with higher scores indicating greater perceived kinesiophobia

  3. Pain intensity [ Time Frame: During the intervention ]
    Pain intensity was measured with the Visual Analog Scale (VAS). It is a single-item and continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, as in this study, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]). To avoid clustering of scores around a preferred numeric value, numbers or verbal descriptors at intermediate points are not recommended. The VAS is a reliable and valid measure of pain (Jensen MP, Turner JA, Romano JM, Fisher LD. Comparative reliability and validity of chronic pain intensity measures.Pain 1999; 83:157-162.) (Katz J, Melzack R. Measurement of pain.Surg Clin North Am 1999; 79:231-252.)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455933


Locations
Spain
CSEU La Salle Madrid
Madrid, Spain, 28008
Sponsors and Collaborators
Centro Universitario La Salle
Investigators
Principal Investigator: Ibai Lopez de Uralde Villanueva La Salle University

Responsible Party: Ibai López de Uralde Villanueva, Clinical Professor and Principal Investigator, Centro Universitario La Salle
ClinicalTrials.gov Identifier: NCT03455933     History of Changes
Other Study ID Numbers: CSEU La Salle
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Asymptomatic Diseases
Disease Attributes
Pathologic Processes