Action Mechanisms of Shock Waves on Pain

Asymptomatic Condition Clinical Trial

Official title:

Action Mechanisms Responsibles for the Effects of Shock Waves on the Pressure Pain Thresholds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455933
• Other study ID #: CSEU La Salle
• Status: Completed
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: May 22, 2018

Study information

• Verified date: June 2018
• Source: Centro Universitario La Salle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 22, 2018
• Est. primary completion date: May 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Asymptomatic Condition
• Asymptomatic Diseases

Intervention

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 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).
• 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.

Locations

Country	Name	City	State
Spain	CSEU La Salle Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitario La Salle

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Catastrophizing	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.).	Baseline
Other	Kinesiophobia level	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	Baseline
Other	Pain intensity	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.)	During the intervention
Primary	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