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

NCT03015662 | Completed

• 1 other identifier: UAL-428
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Fibromyalgia

Keywords

Quality of Life; Fatigue; Anxiety; Physical Therapy Modalities; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Quality of Life (SF-36 quality of life questionnaire)

  Change from baseline quality of life at four weeks

• Impact of Fibromyalgia Symptoms (Fibromyalgia Impact Questionnaire)

  Change from baseline impact of fibromyalgia symptoms at four weeks

• Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)

  Change from baseline quality of life at four weeks

• Pain (Visual Analog Scale)

  Change from baseline pain intensity at four weeks

• Anxiety levels (State-Trait Anxiety Inventory )

  Change from baseline anxiety levels at four weeks

Study Arms (2)

Dry Needling Therapy

EXPERIMENTAL

Active or latent MTrPs (myofascial trigger points) will be remarked in black or red, respectively. Active or latent MTrPs will be needled in the same position employed by the blinded examiner for diagnosis. All dry needling procedures will be performed by the same investigator, and the technique used will be similar to the Hong method, using sterile Ener-Qi needles (EQ 1661) for the punction of TrPs (trigger points).

Other: Dry Needling Therapy

Myofascial Release Therapy

ACTIVE COMPARATOR

Patients will develope a myofascial therapy protocol, administered in the following order: 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.

Other: Myofascial Release Therapy

Interventions

Dry Needling Therapy OTHER

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).

Dry Needling Therapy

Myofascial Release Therapy OTHER

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.

Myofascial Release Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

University of Almeria

Almería, 04120, Spain

Location

Related Publications (8)

• 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.

  PMID: 21673013 BACKGROUND

• 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.

  PMID: 15862479 BACKGROUND

• 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.

  PMID: 16842915 BACKGROUND

• 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.

  PMID: 26075156 BACKGROUND

• 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.

  PMID: 21368661 BACKGROUND

• 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.

  PMID: 26304789 BACKGROUND

• 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.

  PMID: 17449984 BACKGROUND

• 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.

  PMID: 18395479 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Fatigue; Anxiety Disorders; Pain

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Adelaida María Castro-Sánchez, PhD

  Universidad de Almeria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Full Professor

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 10, 2017
• Study Start: January 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 19, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)