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

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Dry Needling Therapy; Other: Myofascial Release Therapy

• Registration Number: NCT03015662
• Lead Sponsor: Universidad de Almeria

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-07
• Study First Posted: 2017-01-10
• Primary Completion: 2017-02
• Study Completion: 2017-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dry Needling Therapy	Dry Needling Therapy	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).
Myofascial Release Therapy	Myofascial Release Therapy	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.

Primary Outcome Measures

Name	Time	Method
Active and Latent Myofascial Trigger Points (Number of trigger Points)	Change from baseline myofascial trigger points at four weeks	Myofascial Trigger Points will be explored in the following pairs of muscles: occipital, splenius capitis, sternocleidomastoid, scalene, trapezius, supraspinatus, infraspinatus, and multifidus.

Secondary Outcome Measures

Name	Time	Method
Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)	Change from baseline quality of life at four weeks	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.
Quality of Life (SF-36 quality of life questionnaire)	Change from baseline quality of life at four weeks	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.
Impact of Fibromyalgia Symptoms (Fibromyalgia Impact Questionnaire)	Change from baseline impact of fibromyalgia symptoms at four weeks	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.
Pain (Visual Analog Scale)	Change from baseline pain intensity at four weeks	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).
Anxiety levels (State-Trait Anxiety Inventory )	Change from baseline anxiety levels at four weeks	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.
State of depression (Beck Depression Inventory)	Change from state of depression at four weeks	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.
Impact of fatigue (Fatigue Impact Scale )	Change from impact of fatigue at four weeks	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.

Trial Locations

Locations (1)

University of Almeria; 🇪🇸 Almeria, Spain