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Trial record 32 of 33 for:    "Depressive Disorder" [DISEASE] AND Behavioral AND BDI | ( Map: Spain )

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

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ClinicalTrials.gov Identifier: NCT03015662
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Adelaida María Castro-Sánchez, 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).

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Dry Needling Therapy Other: Myofascial Release Therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : January 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
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).

Active Comparator: 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.
Other: 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.




Primary Outcome Measures :
  1. Active and Latent Myofascial Trigger Points (Number of trigger Points) [ Time Frame: 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 :
  1. Quality of Life (SF-36 quality of life questionnaire) [ Time Frame: 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.

  2. Impact of Fibromyalgia Symptoms (Fibromyalgia Impact Questionnaire) [ Time Frame: 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.

  3. Quality of Sleep (Pittsburgh Quality of Sleep Questionnaire Index) [ Time Frame: 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.

  4. Pain (Visual Analog Scale) [ Time Frame: 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).

  5. Anxiety levels (State-Trait Anxiety Inventory ) [ Time Frame: 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.

  6. State of depression (Beck Depression Inventory) [ Time Frame: 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.

  7. Impact of fatigue (Fatigue Impact Scale ) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015662


Locations
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Spain
University of Almeria
Almeria, Spain, 04120
Sponsors and Collaborators
Universidad de Almeria
Investigators
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Principal Investigator: Adelaida María Castro-Sánchez, PhD Universidad de Almeria

Publications:

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Responsible Party: Adelaida María Castro-Sánchez, PhD, Full Professor, Universidad de Almeria
ClinicalTrials.gov Identifier: NCT03015662     History of Changes
Other Study ID Numbers: UAL-428
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Adelaida María Castro-Sánchez, Universidad de Almeria:
Quality of Life
Fatigue
Anxiety
Physical Therapy Modalities
Pain
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases