Clinical trial NCT04942444: Effectiveness of Dry Needling in Fibromyalgia Patients
Official title: Dry Needling in Patients With Fibromyalgia: Analysis of Its Therapeutic Effectiveness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Chronic Pain
Anxiety
Depression
Fatigue
Sleep Disorder
Keywords: dry needing
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes in the score of pain.
timeFrame: -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)
measure: Changes in pain in using questionnaires
timeFrame: -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)
measure: Changes in the score of pain.
timeFrame: 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)
measure: Changes in pain in using questionnaires
timeFrame: 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)
measure: Changes in pain in using questionnaires
timeFrame: 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)
measure: Changes in pain in using questionnaires
timeFrame: 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)
Secondary outcomes:
measure: Changes in fatigue
timeFrame: -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)
measure: Changes in fatigue
timeFrame: -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)
measure: Changes in fatigue
timeFrame: -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)
measure: Changes in anxiety
timeFrame: 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)
measure: Changes in anxiety
timeFrame: 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)
measure: Changes in Depression
timeFrame: 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)
measure: Changes in Sleep
timeFrame: 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)
measure: Changes in Quality of Life
timeFrame: 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)
measure: Changes in Quality of Life
timeFrame: 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)
Other outcomes:
measure: Baseline measurements. Demographic variables.
timeFrame: Baseline measurements were performed after eligibility (at week 0)
measure: Baseline measurements. Demographic variables.
timeFrame: Baseline measurements were performed after eligibility (at week 0)
measure: Baseline measurements. Demographic variables.
timeFrame: Baseline measurements were performed after eligibility (at week 0)
measure: Baseline measurements. Demographic variables.
timeFrame: Baseline measurements were performed after eligibility (at week 0)
measure: Baseline measurements. Demographic variables.
timeFrame: Baseline measurements were performed after eligibility (at week 0)
measure: Baseline measurements. Demographic variables.
timeFrame: Baseline measurements were performed after eligibility (at week 0)
Locations:
city: Segovia
country: Spain
facility: Paula Rivas
state: Essg
Study officials:
References:
citation: Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
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citation: Srbely JZ, Dickey JP, Lee D, Lowerison M. Dry needle stimulation of myofascial trigger points evokes segmental anti-nociceptive effects. J Rehabil Med. 2010 May;42(5):463-8. doi: 10.2340/16501977-0535.
citation: Wallace DJ, Linker-Israeli M, Hallegua D, Silverman S, Silver D, Weisman MH. Cytokines play an aetiopathogenetic role in fibromyalgia: a hypothesis and pilot study. Rheumatology (Oxford). 2001 Jul;40(7):743-9. doi: 10.1093/rheumatology/40.7.743.