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Influence of Catastrophism in Fibromyalgia Patients Following Dry Needling Treatment

NCT04238286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-09-11

No results posted yet for this study

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, \[VAS\].

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fundación Universidad Católica de Valencia San Vicente Mártir

    collaborator OTHER

  • Universitat Jaume I

    lead OTHER

Principal Investigators

  • Juan Vicente Mampel, PhD · Universidad Catolica San Vicente Martir

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-07
Primary Completion
2020-07-15
Completion
2020-07-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04238286 on ClinicalTrials.gov