- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03455933
Action Mechanisms of Shock Waves on Pain
June 6, 2018 updated by: Ibai López de Uralde Villanueva, Centro Universitario La Salle
Action Mechanisms Responsibles for the Effects of Shock Waves on the Pressure Pain Thresholds
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Madrid, Spain, 28008
- CSEU La Salle Madrid
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
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.
|
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).
|
Other: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
through study completion, an average of 1 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.).
|
Baseline
|
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
|
Baseline
|
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.)
|
During the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ibai Lopez de Uralde Villanueva, Universidad La Salle, Mexico
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 7, 2018
Primary Completion (Actual)
May 22, 2018
Study Completion (Actual)
May 22, 2018
Study Registration Dates
First Submitted
January 19, 2018
First Submitted That Met QC Criteria
March 5, 2018
First Posted (Actual)
March 7, 2018
Study Record Updates
Last Update Posted (Actual)
June 8, 2018
Last Update Submitted That Met QC Criteria
June 6, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSEU La Salle
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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