Clinical Outcomes After Dry Needling on Cervical Muscles, and Quality of Life, in Patients With Fibromyalgia Syndrome.

Fibromyalgia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015662
• Other study ID #: UAL-428
• Status: Completed
• Phase: N/A
• First received: January 5, 2017
• Last updated: October 18, 2017
• Start date: January 2016
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Dry Needling Therapy
Dry needling procedures will be performed in the following pairs of muscles in the same intervention: occipital, splenius capitis, sternocleidomastoid (Clavicular branch TrPs 1, 2 and 3; sternal branch TrPs 1, 2, 3 and 4), scalene (anterior TrPs 1, and 2; medial TrP (Trigger Point) 1; posterior TrP 1), trapezius (upper TrPs 1, and 2; middle TrPs 5, 6 and 7; lower TrPs 3, and 4), supraspinatus (central point; myotendinous union; tendon insertion), infraspinatus (medial/superior; lateral/superior; lateral scapular side; medial scapular side), and multifidus (level C6).
• Myofascial Release Therapy
Patients will develope a myofascial therapy protocol, administered in the following order in the same intervention: deep fascia release in temporal region, suboccipital release, compression-decompression of temporomandibular joint, global release of cervicodorsal fascia, release of pectoral region, diaphragm release (transverse slide), and transverse diaphragmatic plane.

Locations

Country	Name	City	State
Spain	University of Almeria	Almeria

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Alonso-Blanco C, Fernández-de-las-Peñas C, Morales-Cabezas M, Zarco-Moreno P, Ge HY, Florez-García 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. — View Citation

Castro-Sánchez AM, Matarán-Peñarrocha GA, Arroyo-Morales M, Saavedra-Hernández M, Fernández-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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Vierck CJ Jr. Mechanisms underlying development of spatially distributed chronic pain (fibromyalgia). Pain. 2006 Oct;124(3):242-63. Epub 2006 Jul 13. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Active and Latent Myofascial Trigger Points (Number of trigger Points)	Myofascial Trigger Points will be explored in the following pairs of muscles: occipital, splenius capitis, sternocleidomastoid, scalene, trapezius, supraspinatus, infraspinatus, and multifidus.	Change from baseline myofascial trigger points at four weeks
Secondary	Quality of Life (SF-36 quality of life questionnaire)	The SF-36 quality of life questionnaire assesses 8 domains including physical functioning, physical role, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.	Change from baseline quality of life at four weeks
Secondary	Impact of Fibromyalgia Symptoms (Fibromyalgia Impact Questionnaire)	The Spanish version of Fibromyalgia Impact Questionnaire (FIQ) will be used to assess the impact of FMS symptoms on physical and mental health of patients.	Change from baseline impact of fibromyalgia symptoms at four weeks
Secondary	Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)	The Pittsburgh Quality of Sleep Questionnaire Index (PSQI) will be used to study the quality of sleep. It comprises 24 items where the subjects respond to 19 of these items, and individual living in the same dwelling (or hospital room) responds to the remaining 5. Scores are obtained on each of 7 components of sleep quality: subjective quality, sleep latency, sleep duration, habitual sleep efficacy, sleep perturbations, use of hypnotic medication, and daily dysfunction.	Change from baseline quality of life at four weeks
Secondary	Pain (Visual Analog Scale)	Pain will be assessed with the Visual Analog Scale (VAS), which assesses the pain intensity and degree of relief experienced by the patient (scored of 0 = no pain; 10 = unbearable pain).	Change from baseline pain intensity at four weeks
Secondary	Anxiety levels (State-Trait Anxiety Inventory )	Anxiety levels will be determined with the 40-item State-Trait Anxiety Inventory (STAI), which measures anxiety as a stable dimension of personality (trait or tendency to anxiety) and also includes a state subscale to detect anxiety behaviors.	Change from baseline anxiety levels at four weeks
Secondary	State of depression (Beck Depression Inventory)	The state of depression will be determined with the Beck Depression Inventory (BDI), a self-applied 21-item questionnaire that assesses a wide spectrum of depressive symptoms. It focuses on the cognitive components of depression, which represent around 50% of the total questionnaire score.	Change from state of depression at four weeks
Secondary	Impact of fatigue (Fatigue Impact Scale )	The impact of fatigue will be determined with the Fatigue Impact Scale (FIS). It is a questionnaire-based inventory which requires patients to rate the perceived functional limitations about psychosocial, cognitive, and physical domains (with the maximum score of these sub-scales are 80, 40, and 40, respectively) due to fatigue over the previous month.	Change from impact of fatigue at four weeks