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
|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|
|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|
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.
- 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.
- 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.).
- 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
- 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.)
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
|CSEU La Salle Madrid|
|Madrid, Spain, 28008|
|Principal Investigator:||Ibai Lopez de Uralde Villanueva||La Salle University|