Influence of Catastrophism in Fibromyalgia Patients Following Dry Needling Treatment

NCT04238286 | Completed

• 1 other identifier: U1111-1242-5849 (UTN)
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Myofascial Pain Syndrome; Catastrophizing; Chronic Pain

Keywords

Fibromyalgia; Female; Myofascial trigger points

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain Intensity Measure VAS

  48 hours

• Algometry

  48 hours

Study Arms (3)

Dry needling group

EXPERIMENTAL

Patients treated with dry needling

Procedure: Dry needling

Sham group

SHAM COMPARATOR

Patients treated with a simulated dry needling

Procedure: Dry needling

Control

NO INTERVENTION

Patients never treated

Interventions

Dry needling PROCEDURE

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.

Dry needling group; Sham group

Eligibility Criteria

• Age: 35 Years - 80 Years
• Gender Eligibility Details: Although the condition affects both sexes, women are far more likely to develop fibromyalgia.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of fibromyalgia verified by a qualified rheumatologist according to the ACR criteria
• To have basic spanish skills (be able to understand oral and written spanish language)

You may not qualify if:

• Belonephobia or mimicking pathologies
• Lymphedema
• Pregnancy
• Neoplastic disorders

Sponsors & Collaborators

• Universitat Jaume I: lead
• Fundación Universidad Católica de Valencia San Vicente Mártir: collaborator

Study Sites (1)

Universitat Jaume I

Castellon, Castellón, 12071, Spain

Location

Related Publications (4)

• Ge HY, Fernandez-de-Las-Penas 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.

  PMID: 18203637 BACKGROUND

• 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.

  PMID: 19304392 RESULT

• 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.

  PMID: 22094190 RESULT

• 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.

  PMID: 20889359 RESULT

MeSH Terms

Conditions

Myofascial Pain Syndromes; Chronic Pain; Fibromyalgia

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Juan Vicente Mampel, PhD

  Universidad Catolica San Vicente Martir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 23, 2020
• Study Start: January 7, 2020
• Primary Completion: July 15, 2020
• Study Completion: July 30, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)