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Myofascial Pain SyndromeNCT04238286

Influence of Catastrophism in Fibromyalgia Patients Following Dry Needling Treatment

A study testing Dry needling in people with Myofascial Pain Syndrome and Catastrophizing, run by Universitat Jaume I at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 35 to 80 years, women only
What is being tested?
Dry needling
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteSpain
Study dates
7 Jan 2020to 30 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Universitat Jaume I

    Castellon, Castellón, 12071

Other trials in Spain

About this study

Official title: Analgesic Efficacy of Dry Needling in Fibromyalgia Patients.Influence of Catastrophism in the Successful Intervention

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.

Read more

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].

Read the detailed description

Fibromyalgia syndrome (FS) is currently classified as chronic widespread pain with widespread allodynia (Coster et al., 2008). These symptoms are accompanied by other disorders, such as sleep disturbance, headaches, morning stiffness, irritable bowel syndrome, interstitial cystitis, dyspareunia, mood disturbances and depression (Gerwin, 2005). The World Health Organization recognized FS as a disease in 1992, basing its decision on the diagnostic criteria of the American College of Rheumatology (ACR) which has recently been criticized and updated (Wolfe et al., 2011; Wolfe et al., 2010; Wolfe and Hauser, 2011). Depending on the diagnostic criteria used, the prevalence is from 2% to 8% of the population increasing with age, with highest values attained between 60 and 70 (Stahl, 2009). In Spain, was estimated that 2.4% of the population over 20 years old presents the disease, and it is higher in females than in males (ratio 21:1) (Cordero, 2011).

A central sensitivity syndrome could be the most plausible explanation for chronic widespread pain affecting people with fibromyalgia syndrome. Although it was suggested this condition was the sole cause (Yunus, 2007), central sensitization of the nervous system causes the phenomena of hyperalgesia and allodynia in the individual suffering from chronic pain (Butler and Moseley, 2003) .

The subject with chronic pain has an altered alarm system; this alteration could be initiated by a peripheral sensitization (Sarzi-Puttini et al., 2011) activated by the release of various chemical substances such as substance P, serotonin and bradykinin (Yunus, 2007). Myofascial trigger points (MTrPs) are able to maintain this peripheral sensitization (Affaitati et al., 2011; Ge et al., 2010) by triggering the spontaneous pain patterns experienced by a patient with fibromyalgia syndrome (Ge et al., 2011).

MTrPs contain algogenic substances capable of generating changes in the intensity of pain. Differences in the concentration of these substances between healthy muscle and MTrPs (Shah et al., 2005) have been shown. One of the most effective techniques for the treatment of MTrPs is dry needling (Mayoral, 2010), because it alters the chemical environment of the MTrPs, thus decreasing their sensitization (Dommerholt, 2011). However, there are as until no few studies that have examined the effectiveness of this technique in patients with FS (Chou et al., 2008; Staud, 2006). Moreover, in these patients the perception of pain during and after treatment can be influenced not only by central sensitization, but also by psychosocial variables.

Catastrophization, considered to be the basic psychological construction concerning the perception of pain intensity, is a cognitive and emotional process encompassing magnification of pain-related stimuli, feelings of helplessness, and a generally pessimistic orientation (Labus et al., 2003; Rodero et al., 2010). This catastrophization, understood as a set of negative emotions and cognitive processes, is a risk factor in fibromyalgia and leads to an increase in symptoms, health status warning, symptoms of helplessness and pessimism (Alegre de Miquel and Sellas Fernandez, 2008; Sullivan et al., 2001).

These negative thoughts lead to alterations in the function of the descending inhibitory pathways that modulate pain (Wideman and Sullivan, 2011) producing an increase in the pain's intensity and exaggerated pain behavior (Wideman and Sullivan, 2012). Several lines of research suggest that this psychological construct is an indicator of poor results obtained from various treatments (surgical, pharmacological and psychological interventions in pain management) (Sullivan et al., 2009; Mankovsky et al., 2012; Sullivan et al., 2005).

Catastrophizing is an important factor in the pathophysiological FM, which also influences the perception of pain and the effects of the various treatments mentioned above. Several studies have shown that catastrophizing increases attention at the site of injury and increases the fear of pain that patient refers (McMahon et al., 2013; Sullivan et al., 2001). However, how this psychological construct may influence both factors - the treatment effectiveness of MTrPs by dry needling and the perception of pain during this treatment - is still unknown.

Subjects who experience high levels of catastrophizing have been demonstrated as having increased emotional and physical stress in response to a painful episode. It would therefore be interesting to analyze whether high levels of catastrophizing may influence and be related with high levels of perceived pain during and after dry needling treatment.

The main objective of our study is to assess whether catastrophizing could influence the perception of pain during and after dry needling application.

Being tested
Dry needling
Keywords
Fibromyalgia, Female, Myofascial trigger points
Medical subject headings
Myofascial Pain Syndromes, Chronic Pain, Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry needlingProcedure or surgery

    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.

Study groups in NCT04238286
Study groupRoleWhat they receive
Dry needling groupExperimentalPatients treated with dry needling
Receives: Procedure: Dry needling
Sham groupSham comparatorPatients treated with a simulated dry needling
Receives: Procedure: Dry needling
ControlNo interventionPatients never treated

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 48 hours

Secondary outcomes (2)
  1. 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].

    Measured: 48 hours

  2. Algometry

    Measurement of pain by means of an algometer, an instrument for determining sensitivity to pain produced by pressure (Kg/cm2).

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2020
  2. Study start7 Jan 2020
  3. Primary completion15 Jul 2020
  4. Study completion30 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04238286
Sponsor's protocol ID
U1111-1242-5849 (UTN)
Status last verified
Sep 2020
First submitted
20 Jan 2020
Last updated
11 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18203637
  • 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.

    PubMed 19304392
  • 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.

    PubMed 22094190
  • 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.

    PubMed 20889359

Questions about this trial

What is this clinical trial studying?

A study testing Dry needling in people with Myofascial Pain Syndrome and Catastrophizing, run by Universitat Jaume I at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Pain Catastrophizing Scale (PCS) is a 13-item self-administered scale and one of the most widely used to assess pain catastrophizing (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04238286, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.

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