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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04238286
Other study ID # U1111-1242-5849 (UTN)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 7, 2020
Est. completion date July 30, 2020

Study information

Verified date September 2020
Source Universitat Jaume I
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Dry needling trigger point treatment, while painful, has been demonstrated as a useful tool in fibromyalgia patients for decreasing pain and central sensitization. However, the current biopsychosocial pain paradigm indicates that fibromyalgia subjects with high levels of catastrophizing have negative thoughts related with perceived partner responses to pain, which results in an emotional and physical stress after a painful episode.

Objective: To assess whether catastrophizing could influence the perception of pain during and after dry needling application.

Study design: A singled-blind randomized controlled trial.

Setting: Department of Medicine, Faculty of Health Sciences, Universitat Jaume I

Methods: Female fibromyalgia patients and number and age-matched female controls will be recruited and randomly assigned to either a real or a simulated dry needling group. The Spanish version of the pain catastrophizing scale will be used to assess the catastrophizing level of each participant before initiating any of the planned interventions. The perceived pain during and immediately after the dry needling procedure will be measured using the pain visual analogue scale, [VAS].


Description:

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Study Design


Intervention

Procedure:
Dry needling
All the participants will be placed in a prone position on the bench. Once the subject is settled, we will localize a nodule within the palpable taut band, confirming its presence after inducing local twitch response by palpation. After placing the MTrPs, the area will be sterilized with an alcohol solution colorless spray [Skin-des. Agupunt ®]. The puncture method used in the true dry needling groups will be the Hong's fast in-fast out technique, described as the most aggressive technique in the MTrPs treatment, using a needle of 0.32 x 40 mm. The intervention will be implemented until the subject reports the presence of seven local twitch reactions to the controller.

Locations

Country Name City State
Spain Universitat Jaume I Castellón De La Plana Castellón

Sponsors (2)

Lead Sponsor Collaborator
Universitat Jaume I Fundación Universidad Católica de Valencia San Vicente Mártir

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Affaitati G, Costantini R, Fabrizio A, Lapenna D, Tafuri E, Giamberardino MA. Effects of treatment of peripheral pain generators in fibromyalgia patients. Eur J Pain. 2011 Jan;15(1):61-9. doi: 10.1016/j.ejpain.2010.09.002. — View Citation

Ge HY, Fernández-de-Las-Peñas C, Madeleine P, Arendt-Nielsen L. Topographical mapping and mechanical pain sensitivity of myofascial trigger points in the infraspinatus muscle. Eur J Pain. 2008 Oct;12(7):859-65. doi: 10.1016/j.ejpain.2007.12.005. Epub 2008 Jan 18. — View Citation

Sarzi-Puttini P, Atzeni F, Mease PJ. Chronic widespread pain: from peripheral to central evolution. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):133-9. doi: 10.1016/j.berh.2011.04.001. Review. — View Citation

Sullivan M, Tanzer M, Stanish W, Fallaha M, Keefe FJ, Simmonds M, Dunbar M. Psychological determinants of problematic outcomes following Total Knee Arthroplasty. Pain. 2009 May;143(1-2):123-9. doi: 10.1016/j.pain.2009.02.011. Epub 2009 Mar 21. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Pain Catastrophizing Scale (PCS) is a 13-item self-administered scale and one of the most widely used to assess pain catastrophizing The theoretical range of the instrument is between 0 and 52, with low scores indicating low catastrophizing, and high values showing high catastrophizing. Compare to others this questionnaire is unique since the individual does not need to be in pain while completing it. 48 hours
Secondary Pain Intensity Measure VAS The pain visual analogue scale [VAS] is designed to provide a broad and comprehensive assessment, albeit a subjective one, of the pain dimensions. A visual analogue scale is a straight vertical or horizontal line, the length of which represents the continuum of the painful experience. It consists of a 10 cm horizontal line, with perpendicular lines at the ends representing the inner and outer limits of the measured pain construct. The anchor points at each end point are characterized by a brief verbal expression such as 'nothing' or 'no pain' at one end and "unbearable" at the other. Verbal descriptors are usually accompanied by a number [e.g., "nothing" can be accompanied by 0 and "unbearable" by 10]. 48 hours
Secondary Algometry Measurement of pain by means of an algometer, an instrument for determining sensitivity to pain produced by pressure (Kg/cm2). 48 hours
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