Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04942444
Study type Interventional
Source CEU San Pablo University
Contact Paula Rivas
Phone +34677204884
Email paula.rivascalvo@ceu.es
Status Recruiting
Phase N/A
Start date January 10, 2011
Completion date July 1, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A