Clinical trial NCT03015662: Clinical Outcomes After Dry Needling on Cervical Muscles, and Quality of Life, in Patients With Fibromyalgia Syndrome.
Official title: Clinical Outcomes After Dry Needling on Cervical Muscles, Quality of Life, Fatigue, Quality of Sleep, Anxiety and Depression in Patients With Fibromyalgia Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Quality of Life
Fatigue
Anxiety
Physical Therapy Modalities
Pain
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: The purpose of the current randomized clinical trial is to compare the effectiveness of dry needling versus myofascial release therapy on myofascial trigger points (MTrPs) in cervical muscles, quality of life, fatigue, quality of sleep, anxiety and depression in patients with fibromyalgia syndrome (FMS).

Detailed description: Design: A single-blind randomized controlled trial will be conducted on patients with FMS.

Methods: Sixty-four subjects with FMS will be randomly assigned to an experimental group receiving dry needling therapy, or to a control group for myofascial release therapy in the trigger points active or latent in the following pairs of muscles: occipital, splenius capitis, sternocleidomastoid, scalene, trapezius, supraspinatus, infraspinatus, and multifidus. Myofascial trigger points, quality of life, impact of fibromyalgia symptoms, quality of sleep, intensity of pain, anxiety levels, state of depression, impact of fatigue will be recorded at baseline and after four weeks of treatment.

Eligibility criteria: Inclusion Criteria:

* Fibromyalgia syndrome diagnosis.
* Aged from 18 to 60 years.
* No regular physical activity.
* Limitation of usual activities due to pain on at least 1 day in the previous 30 days.
* Agreement to attend evening therapy sessions

Exclusion Criteria:

* Receipt of any no pharmacologic therapies.
* Presence of cardiac, renal or hepatic insufficiency.
* Severe physical disability.
* Comorbid condition (eg, inflammatory disease).
* Infection fever.
* Hypotension.
* Skin alterations.
* Psychiatric illness.
* Previous history of surgery.

Primary outcomes:
measure: Active and Latent Myofascial Trigger Points (Number of trigger Points)
timeFrame: Change from baseline myofascial trigger points at four weeks
Secondary outcomes:
measure: Quality of Life (SF-36 quality of life questionnaire)
timeFrame: Change from baseline quality of life at four weeks
measure: Impact of Fibromyalgia Symptoms (Fibromyalgia Impact Questionnaire)
timeFrame: Change from baseline impact of fibromyalgia symptoms at four weeks
measure: Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)
timeFrame: Change from baseline quality of life at four weeks
measure: Pain (Visual Analog Scale)
timeFrame: Change from baseline pain intensity at four weeks
measure: Anxiety levels (State-Trait Anxiety Inventory )
timeFrame: Change from baseline anxiety levels at four weeks
measure: State of depression (Beck Depression Inventory)
timeFrame: Change from state of depression at four weeks
measure: Impact of fatigue (Fatigue Impact Scale )
timeFrame: Change from impact of fatigue at four weeks
Other outcomes:
Locations:
city: Almeria
country: Spain
facility: University of Almeria
Study officials:
affiliation: Universidad de Almeria
name: Adelaida María Castro-Sánchez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Castro-Sanchez AM, Mataran-Penarrocha GA, Arroyo-Morales M, Saavedra-Hernandez M, Fernandez-Sola C, Moreno-Lorenzo C. Effects of myofascial release techniques on pain, physical function, and postural stability in patients with fibromyalgia: a randomized controlled trial. Clin Rehabil. 2011 Sep;25(9):800-13. doi: 10.1177/0269215511399476. Epub 2011 Jun 14.
citation: Montoya P, Pauli P, Batra A, Wiedemann G. Altered processing of pain-related information in patients with fibromyalgia. Eur J Pain. 2005 Jun;9(3):293-303. doi: 10.1016/j.ejpain.2004.07.012.
citation: Vierck CJ Jr. Mechanisms underlying development of spatially distributed chronic pain (fibromyalgia). Pain. 2006 Oct;124(3):242-263. doi: 10.1016/j.pain.2006.06.001. Epub 2006 Jul 13.
citation: Unverzagt C, Berglund K, Thomas JJ. DRY NEEDLING FOR MYOFASCIAL TRIGGER POINT PAIN: A CLINICAL COMMENTARY. Int J Sports Phys Ther. 2015 Jun;10(3):402-18.
citation: Alonso-Blanco C, Fernandez-de-las-Penas C, Morales-Cabezas M, Zarco-Moreno P, Ge HY, Florez-Garcia M. Multiple active myofascial trigger points reproduce the overall spontaneous pain pattern in women with fibromyalgia and are related to widespread mechanical hypersensitivity. Clin J Pain. 2011 Jun;27(5):405-13. doi: 10.1097/AJP.0b013e318210110a.
citation: Yeganeh Lari A, Okhovatian F, Naimi Ss, Baghban AA. The effect of the combination of dry needling and MET on latent trigger point upper trapezius in females. Man Ther. 2016 Feb;21:204-9. doi: 10.1016/j.math.2015.08.004. Epub 2015 Aug 14.
citation: Hsieh YL, Kao MJ, Kuan TS, Chen SM, Chen JT, Hong CZ. Dry needling to a key myofascial trigger point may reduce the irritability of satellite MTrPs. Am J Phys Med Rehabil. 2007 May;86(5):397-403. doi: 10.1097/PHM.0b013e31804a554d.
citation: Tough EA, White AR, Cummings TM, Richards SH, Campbell JL. Acupuncture and dry needling in the management of myofascial trigger point pain: a systematic review and meta-analysis of randomised controlled trials. Eur J Pain. 2009 Jan;13(1):3-10. doi: 10.1016/j.ejpain.2008.02.006. Epub 2008 Apr 18.