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NCT Number: NCT03455933

Action Mechanisms of Shock Waves on Pain

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).

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Key information

Conditions

Asymptomatic Condition Asymptomatic Diseases Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CSEU La Salle Madrid

Madrid, 28008, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

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.

Primary outcomes

  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 outcomes

  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.)

Sponsors and collaborators

Lead sponsor

Centro Universitario La Salle

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2018
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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