An interventional study of Sham Comparator and Experimental Intervention in Asymptomatic Condition, sponsored by Centro Universitario La Salle. Completed at 1 site in Spain. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-08.
Sponsored by Centro Universitario La Salle · Not applicable, Interventional, and Basic science
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).
38 studies on the registry are indexed under Asymptomatic Diseases; 8 are open to participants now.
This study's enrollment of 63 is above the median of 50 across 28 interventional studies indexed under Asymptomatic Diseases.
Browse Asymptomatic Diseases studies →Centro Universitario La Salle is the lead sponsor of 25 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
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
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
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
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).
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).
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.
Pressure pain threshold
The investigators will use a digital algometer (Force Ten FDX Wagner) to measure when pressure becomes pain.
Time frame: through study completion, an average of 1 month
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.).
Time frame: Baseline
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
Time frame: Baseline
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.)
Time frame: During the intervention
Plan to share: Undecided
Ran from May 2018 to primary completion in May 2018, 0 months.
Of 17 interventional studies with no phase under Asymptomatic Diseases, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 19. This study's 0 months is below that.
Asymptomatic Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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