<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03015662</url>
  </required_header>
  <id_info>
    <org_study_id>UAL-428</org_study_id>
    <nct_id>NCT03015662</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes After Dry Needling on Cervical Muscles, and Quality of Life, in Patients With Fibromyalgia Syndrome.</brief_title>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Almeria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Almeria</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: The purpose of the current randomized clinical trial is to compare the&#xD;
      effectiveness of dry needling versus myofascial release therapy on myofascial trigger points&#xD;
      (MTrPs) in cervical muscles, quality of life, fatigue, quality of sleep, anxiety and&#xD;
      depression in patients with fibromyalgia syndrome (FMS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: A single-blind randomized controlled trial will be conducted on patients with FMS.&#xD;
&#xD;
      Methods: Sixty-four subjects with FMS will be randomly assigned to an experimental group&#xD;
      receiving dry needling therapy, or to a control group for myofascial release therapy in the&#xD;
      trigger points active or latent in the following pairs of muscles: occipital, splenius&#xD;
      capitis, sternocleidomastoid, scalene, trapezius, supraspinatus, infraspinatus, and&#xD;
      multifidus. Myofascial trigger points, quality of life, impact of fibromyalgia symptoms,&#xD;
      quality of sleep, intensity of pain, anxiety levels, state of depression, impact of fatigue&#xD;
      will be recorded at baseline and after four weeks of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Active and Latent Myofascial Trigger Points (Number of trigger Points)</measure>
    <time_frame>Change from baseline myofascial trigger points at four weeks</time_frame>
    <description>Myofascial Trigger Points will be explored in the following pairs of muscles: occipital, splenius capitis, sternocleidomastoid, scalene, trapezius, supraspinatus, infraspinatus, and multifidus.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (SF-36 quality of life questionnaire)</measure>
    <time_frame>Change from baseline quality of life at four weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of Fibromyalgia Symptoms (Fibromyalgia Impact Questionnaire)</measure>
    <time_frame>Change from baseline impact of fibromyalgia symptoms at four weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)</measure>
    <time_frame>Change from baseline quality of life at four weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain (Visual Analog Scale)</measure>
    <time_frame>Change from baseline pain intensity at four weeks</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety levels (State-Trait Anxiety Inventory )</measure>
    <time_frame>Change from baseline anxiety levels at four weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State of depression (Beck Depression Inventory)</measure>
    <time_frame>Change from state of depression at four weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of fatigue (Fatigue Impact Scale )</measure>
    <time_frame>Change from impact of fatigue at four weeks</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Dry Needling Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Myofascial Release Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry Needling Therapy</intervention_name>
    <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).</description>
    <arm_group_label>Dry Needling Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Myofascial Release Therapy</intervention_name>
    <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.</description>
    <arm_group_label>Myofascial Release Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fibromyalgia syndrome diagnosis.&#xD;
&#xD;
          -  Aged from 18 to 60 years.&#xD;
&#xD;
          -  No regular physical activity.&#xD;
&#xD;
          -  Limitation of usual activities due to pain on at least 1 day in the previous 30 days.&#xD;
&#xD;
          -  Agreement to attend evening therapy sessions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receipt of any no pharmacologic therapies.&#xD;
&#xD;
          -  Presence of cardiac, renal or hepatic insufficiency.&#xD;
&#xD;
          -  Severe physical disability.&#xD;
&#xD;
          -  Comorbid condition (eg, inflammatory disease).&#xD;
&#xD;
          -  Infection fever.&#xD;
&#xD;
          -  Hypotension.&#xD;
&#xD;
          -  Skin alterations.&#xD;
&#xD;
          -  Psychiatric illness.&#xD;
&#xD;
          -  Previous history of surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adelaida María Castro-Sánchez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Almeria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Almeria</name>
      <address>
        <city>Almeria</city>
        <zip>04120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <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>
    <PMID>21673013</PMID>
  </reference>
  <reference>
    <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>
    <PMID>15862479</PMID>
  </reference>
  <reference>
    <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>
    <PMID>16842915</PMID>
  </reference>
  <reference>
    <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>
    <PMID>26075156</PMID>
  </reference>
  <reference>
    <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>
    <PMID>21368661</PMID>
  </reference>
  <reference>
    <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>
    <PMID>26304789</PMID>
  </reference>
  <reference>
    <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>
    <PMID>17449984</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18395479</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>October 18, 2017</last_update_submitted>
  <last_update_submitted_qc>October 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Almeria</investigator_affiliation>
    <investigator_full_name>Adelaida María Castro-Sánchez</investigator_full_name>
    <investigator_title>PhD, Full Professor</investigator_title>
  </responsible_party>
  <keyword>Quality of Life</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Physical Therapy Modalities</keyword>
  <keyword>Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03015662
org study id: UAL-428
nct id: NCT03015662
lead sponsor: 
has dmc: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Active and Latent Myofascial Trigger Points (Number of trigger Points)
time frame: Change from baseline myofascial trigger points at four weeks
description: Myofascial Trigger Points will be explored in the following pairs of muscles: occipital, splenius capitis, sternocleidomastoid, scalene, trapezius, supraspinatus, infraspinatus, and multifidus.
measure: Quality of Life (SF-36 quality of life questionnaire)
time frame: Change from baseline quality of life at four weeks
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.
measure: Impact of Fibromyalgia Symptoms (Fibromyalgia Impact Questionnaire)
time frame: Change from baseline impact of fibromyalgia symptoms at four weeks
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.
measure: Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index)
time frame: Change from baseline quality of life at four weeks
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.
measure: Pain (Visual Analog Scale)
time frame: Change from baseline pain intensity at four weeks
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).
measure: Anxiety levels (State-Trait Anxiety Inventory )
time frame: Change from baseline anxiety levels at four weeks
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.
measure: State of depression (Beck Depression Inventory)
time frame: Change from state of depression at four weeks
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.
measure: Impact of fatigue (Fatigue Impact Scale )
time frame: Change from impact of fatigue at four weeks
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.
arm group label: Dry Needling Therapy
arm group type: Experimental
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 group label: Myofascial Release Therapy
arm group type: Active Comparator
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: Dry Needling Therapy
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).
arm group label: Dry Needling Therapy
intervention type: Other
intervention name: Myofascial Release Therapy
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.
arm group label: Myofascial Release Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Adelaida María Castro-Sánchez, PhD
role: Principal Investigator
affiliation: Universidad de Almeria
facility: 
country: Spain
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.
PMID: 21673013
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.
PMID: 15862479
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.
PMID: 16842915
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.
PMID: 26075156
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.
PMID: 21368661
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.
PMID: 26304789
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.
PMID: 17449984
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.
PMID: 18395479
responsible party type: Principal Investigator
investigator affiliation: Universidad de Almeria
investigator full name: Adelaida María Castro-Sánchez
investigator title: PhD, Full Professor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: No