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Effectiveness of Dry Needling in Fibromyalgia Patients

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ClinicalTrials.gov Identifier: NCT04942444
Recruitment Status : Recruiting
First Posted : June 28, 2021
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
Paula Rivas Calvo, CEU San Pablo University

Brief Summary:
Patients with fibromyalgia (FM) complain of widespread chronic pain from deep tissues including muscles. Previous research highlights the relevance of impulse input from deep tissues for clinical FM pain. Deep dry needle stimulation is an invasive treatment modality used in the management of musculoskeletal pain. Its efficacy has been confirmed in the management of myofascial trigger points, so the purpose of the study is to determine if blocking abnormal impulse input with deep dry needling stimulation of tender point may decrease hyperalgesia, clinical pain and associated symptoms such as anxiety, depression, fatigue and improve the quality of life in FM patients.

Condition or disease Intervention/treatment Phase
Fibromyalgia Chronic Pain Anxiety Depression Fatigue Sleep Disorder Other: Dry needling Not Applicable

Detailed Description:

Fibromyalgia (FM) is characterized by chronic widespread musculoskeletal pain that is often associated to other manifestations such as fatigue, sleep disturbances, anxiety and depression. FM diagnosis may be performed following the 1990 American College of Rheumatology (ACR) classification criteria that require a history of widespread pain for at least 3 months and tenderness in at least 11 of 18 defined tender points.

Dry needling is a broad term used to differentiate "non-injection" needling from the practice of "injection needling". In contrast to injection of an agent, dry needling utilizes a solid filament needle, as is used in the practice of acupuncture, and relies on the stimulation of specific reactions in the target tissue for its therapeutic effect. Is a relatively new treatment modality used by physicians and physical therapists worldwide as a part of complex treatment of chronic musculoskeletal pain. It is minimally invasive, cheap, easy to learn, and carries a low risk of complications. Its efficacy has been confirmed in numerous studies and systematic reviews on management of myofascial trigger points, acute and chronic low back pain, chronic lumbar myofascial trigger points, lumbar myofascial pain, chronic whiplash, and myofascial pain and headaches.

The clinical picture of FM suggests an increased activity and/or hypersensitivity in nociceptive pathways or inadequate activity in endogenous pain attenuation mechanisms. Administration of local injections of lidocaine in the tender points is considered a therapeutic approach in the management of FM and this therapy increases plasma concentrations of met-enkephalin. FM patients treated with dry needling also experience a rapid increase of plasma levels of met-enkephalin. Results derived from randomized clinical trials and systematic reviews disclosed no differences between injections of different substances and dry needling in the treatment of myofascial trigger points symptoms. These findings suggest that needling techniques may be effective in the management of FM.

Taken together all these considerations, the primary aim of this study is to investigate the efficacy of dry needling as a complementary treatment of severely affected FM patients. In addition, the investigators, aimed to establish whether this procedure might still yield some clinical improvement 6 weeks after the discontinuation of this intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dry Needling in Patients With Fibromyalgia: Analysis of Its Therapeutic Effectiveness
Actual Study Start Date : January 10, 2011
Actual Primary Completion Date : February 1, 2011
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
No Intervention: Control Group
Patients from the control group kept on taking the same medical treatment that they received before randomization
Experimental: Dry needling group
Besides maintaining their current medical treatment, patients from the experimental group received an additional weekly one-hour session of dry needling over the 18 tender points for a 6-week-period.
Other: Dry needling
One-hour weekly session of DN in the 18th tender points during 6 weeks in the DNG, apart from continuing their medical treatment. The CG continue with the habitual medical treatment.




Primary Outcome Measures :
  1. Changes in the score of pain. [ Time Frame: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention) ]
    - Dolorimeter for assessing the myalgic score. Rank values 0 (best outcome) to 10 (worst outcome)

  2. Changes in pain in using questionnaires [ Time Frame: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention) ]
    Fibromyalgia Impact Questionnaire (FIQ). Rank values from 0 (best outcome) to 100 (worst outcome)

  3. Changes in the score of pain. [ Time Frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention) ]
    - Visual Analogue Scale (VAS). Rank values 0 (best outcome) to 10 (worst outcome)

  4. Changes in pain in using questionnaires [ Time Frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention) ]

    McGill Pain Questionnaire (MPQ) The Pain Rating Index (PRI) score indices range from 0-78 based on the rank values of the chosen words. The value (score) associated with each descriptor is based on its position or rank order in the set of words, so that the first word receives a value of 1, the next a value of 2, and so on. Range values are summed within each subclass as well as in general. The PPI (Present pain intensity) ranges from 0-5. Scoring example: Temporal Group I: Periodic (1 point), Repetitive (2 points), Insistent (3 points), Endless (4 points). Each aspect that is assessed fits into four subscales: 1 to 10, sensitive subscale, 11 to 15, affective subscale; 16, evaluative subscale; 17 to 20, subscale of diverse aspects. Especially aimed at chronic pain.

    Chronic Pain Acceptance Questionnaire (CPAQ)


  5. Changes in pain in using questionnaires [ Time Frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention) ]
    Chronic Pain Acceptance Questionnaire (CPAQ). Rank values from 0 (worst outcome) to 120 (best outcome)

  6. Changes in pain in using questionnaires [ Time Frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention) ]
    Pain Catastrophizing Scale (PCS). Rank values from 0 (best outcome) to 52 (worst outcome)


Secondary Outcome Measures :
  1. Changes in fatigue [ Time Frame: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention) ]
    - Six-minute walk test for the fatigue.

  2. Changes in fatigue [ Time Frame: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention) ]
    Visual Analogue Scale of Fatigue (VAS). Rank value from 0 (best outcome) to 10 (worst outcome)

  3. Changes in fatigue [ Time Frame: -At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention) ]
    Fatigue Severity Scale Questionnaire (FSS). Rank values from 0 (best outcome) to 63 (worst outcome)

  4. Changes in anxiety [ Time Frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention) ]
    -Beck Anxiety Inventory (BAI). Rank values from 0 (best outcome) to 63 (worst outcome).

  5. Changes in anxiety [ Time Frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention) ]
    - Visual Analogue Scale of Anxiety (VAS).Rank values from 0 (best outcome) to 10 (worst outcome)

  6. Changes in Depression [ Time Frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention) ]
    - Beck Depression Inventory (BDI). Rank values from 0 (best outcome) to 63 (worst outcome).

  7. Changes in Sleep [ Time Frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention) ]
    Pittsburgh Sleep Quality Index (PSQI). Rank values from 0 (best outcome) to 21 (worst outcome)

  8. Changes in Quality of Life [ Time Frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention) ]
    • Stanford Health Assessment Questionnaire (SHAQ). Rank values from 0 (best outcome) to 3 (worst outcome).
    • Medical Outcomes Survey Short Form-36 (SF-36)

  9. Changes in Quality of Life [ Time Frame: At the start of the treatment (week 0) -At the end of the 6-week intervention period (this time considered as end of intervention). -Finally, patients were again evaluated 6 week later (at week 12 after finishing the dry needling intervention) ]
    - Medical Outcomes Survey Short Form-36 (SF-36). Rank values from 0 (worst outcome) to 100 (best outcome)


Other Outcome Measures:
  1. Baseline measurements. Demographic variables. [ Time Frame: Baseline measurements were performed after eligibility (at week 0) ]
    - Material status

  2. Baseline measurements. Demographic variables. [ Time Frame: Baseline measurements were performed after eligibility (at week 0) ]
    - Employment status

  3. Baseline measurements. Demographic variables. [ Time Frame: Baseline measurements were performed after eligibility (at week 0) ]
    - Education status

  4. Baseline measurements. Demographic variables. [ Time Frame: Baseline measurements were performed after eligibility (at week 0) ]
    Years until disease diagnosis

  5. Baseline measurements. Demographic variables. [ Time Frame: Baseline measurements were performed after eligibility (at week 0) ]
    - Body mass index

  6. Baseline measurements. Demographic variables. [ Time Frame: Baseline measurements were performed after eligibility (at week 0) ]
    - Number of physical symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who had not responded to any of the previously used pharmacological and non-pharmacological treatments.
  • Literate and able to complete the questionnaires and scales used in the study.
  • Patients who accepted their inclusion in the trial signed the corresponding informed consent and were given an explanatory sheet of the project.

Exclusion Criteria:

  • Patients with CNS involvement with or without treatment (stroke, Parkinson's, dementia, multiple sclerosis, etc.).
  • Patients with inflammatory or autoimmune disease associated with Fibromyalgia.
  • Patients with infectious, neoplastic disease, or parenteral drug use.
  • Patients with insurmountable fear of needles
  • Under 18 years of age
  • Coagulation problems (including treatment with anticoagulants, due to the risk of bleeding).
  • Immunosuppressed people (due to the risk of infection),
  • Lymphadenectomized people (due to the risk of lymphedema)
  • Hypothyroidism (due to the risk of myxedema)
  • Pregnant patients
  • Patients with areas of the skin that present some type of wound, infection, macula or tattoo.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04942444


Contacts
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Contact: Paula Rivas +34677204884 paula.rivascalvo@ceu.es

Locations
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Spain
Paula Rivas Recruiting
Segovia, Essg, Spain, 40002
Contact: Paula Rivas    +34677204884    paula.rivascalvo@ceu.es   
Sponsors and Collaborators
CEU San Pablo University
Publications:

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Responsible Party: Paula Rivas Calvo, Prof. Colaborador Doctor Paula Rivas Calvo, CEU San Pablo University
ClinicalTrials.gov Identifier: NCT04942444    
Other Study ID Numbers: CEU-0021
First Posted: June 28, 2021    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paula Rivas Calvo, CEU San Pablo University:
dry needing
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Sleep Wake Disorders
Chronic Pain
Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Mental Disorders