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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry Needling Therapy
Myofascial Release Therapy
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Quality of Life, Fatigue, Anxiety, Physical Therapy Modalities, Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Almeria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry Needling Therapy

Myofascial Release Therapy

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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).
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.
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.
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.

Full Information

First Posted
January 5, 2017
Last Updated
October 18, 2017
Sponsor
Universidad de Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT03015662
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Quality of Life, Fatigue, Anxiety, Physical Therapy Modalities, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling Therapy
Arm Type
Experimental
Arm Description
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).
Arm Title
Myofascial Release Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry Needling Therapy
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Myofascial Release Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Active and Latent Myofascial Trigger Points (Number of trigger Points)
Description
Myofascial Trigger Points will be explored in the following pairs of muscles: occipital, splenius capitis, sternocleidomastoid, scalene, trapezius, supraspinatus, infraspinatus, and multifidus.
Time Frame
Change from baseline myofascial trigger points at four weeks
Secondary Outcome Measure Information:
Title
Quality of Life (SF-36 quality of life questionnaire)
Description
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.
Time Frame
Change from baseline quality of life at four weeks
Title
Impact of Fibromyalgia Symptoms (Fibromyalgia Impact Questionnaire)
Description
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.
Time Frame
Change from baseline impact of fibromyalgia symptoms at four weeks
Title
Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)
Description
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.
Time Frame
Change from baseline quality of life at four weeks
Title
Pain (Visual Analog Scale)
Description
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).
Time Frame
Change from baseline pain intensity at four weeks
Title
Anxiety levels (State-Trait Anxiety Inventory )
Description
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.
Time Frame
Change from baseline anxiety levels at four weeks
Title
State of depression (Beck Depression Inventory)
Description
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.
Time Frame
Change from state of depression at four weeks
Title
Impact of fatigue (Fatigue Impact Scale )
Description
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.
Time Frame
Change from impact of fatigue at four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelaida María Castro-Sánchez, PhD
Organizational Affiliation
Universidad de Almeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Almeria
City
Almeria
ZIP/Postal Code
04120
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21673013
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.
Results Reference
background
PubMed Identifier
15862479
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.
Results Reference
background
PubMed Identifier
16842915
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.
Results Reference
background
PubMed Identifier
26075156
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.
Results Reference
background
PubMed Identifier
21368661
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.
Results Reference
background
PubMed Identifier
26304789
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.
Results Reference
background
PubMed Identifier
17449984
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.
Results Reference
background
PubMed Identifier
18395479
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.
Results Reference
background

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

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