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Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158388
Recruitment Status : Completed
First Posted : November 8, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante

Brief Summary:
The study had two objectives. The first main aim was to analyze the effects of tryptophan and magnesium-enriched Mediterranean diet on psychological variables (trait anxiety, self-image, mood state, eating disorders) and sleep effects in women with fibromyalgia. Our hypothesis, based on previous positive effects of tryptophan and magnesium supplementation by separate in this population, may improve psychological health and regulate sleep disruptions. The second aim was to assess the effectiveness of a manual therapy technique performed with moderate digital pressure in fibromyalgia patients on the variables of fatigue, pain, sleep, anxiety and mood. It was done to provide an alternative treatment to pharmacological therapies for fibromyalgia patients and to provide new evidence on the effects of manual therapy in fibromyalgia patients.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Mediterranean-diet enriched with a higher dose of tryptophan and magnesium Other: Isocaloric diet Other: Manual therapy Other: Placebo therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Nutritional Strategies or Manual Therapies on Physical and Psychological Parameters in Women With Fybromyalgia.
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : October 9, 2019
Actual Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: EXPERIMENTAL DIET GROUP Other: Mediterranean-diet enriched with a higher dose of tryptophan and magnesium
That gruop eaten at both breakfast and dinner from walnuts (3-5 units), as food with high values of tryptophan and magnesium

CONTROL GROUP Other: Isocaloric diet
That group eaten isocaloric diet plan based on Mediterranean diet.

Experimental: EXPERIMENTAL MASSAGE GROUP
That group received moderate pressure digital manual therapy.
Other: Manual therapy
That group received moderate pressure digital manual therapy.

Experimental: EXPERIMENTAL PLACEBO GROUP
That group was treated with a US (in off mode) without conductive gel. Placebo group.
Other: Placebo therapy
That group was treated with a US (in off mode) without conductive gel.




Primary Outcome Measures :
  1. Sleep Quality [ Time Frame: 4 - 16 weeks ]
    Sleep Quality assessment: Athenas Insomnia Scale.

  2. Anxiety trait [ Time Frame: 4 - 16 weeks ]
    Anxiety trait assessment: Stay Trait Anxiety Inventory.

  3. Mood state [ Time Frame: 4 - 16 weeks ]
    Mood state assessment: Profile of Mood State inventory.

  4. Fatigue severity [ Time Frame: 4 - 16 weeks ]
    Fatigue severity assessment: Fatigue Severity Scale

  5. Pain perception [ Time Frame: 4 - 16 weeks ]
    Pain perception assessment: Visual Analogical Scale

  6. Sleep quality [ Time Frame: 4 - 16 weeks ]
    Sleep quality assessment: Pittsburgh Sleep Quality Index


Secondary Outcome Measures :
  1. Body composition [ Time Frame: 4 - 16 weeks ]
    Body composition assessment trough bioimpedance.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Women aged 40-60 with fibromialgia (officially diagnosed).

Exclusion Criteria:

  • Women used analgesics, vitamins containing supplements, and or other drugs for the treatment of fibromyalgia symptoms, or participation in other clinical trials.
  • Women that be performing simultaneously to this study some other physical therapy or physical exercise treatment. Not having sufficient cognitive level to collaborate in the study or not having the possibility of attending the established sessions.

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): NCT04158388


Locations
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Spain
University of Alicante
Alicante, San Vicente Del Raspeig, Spain, 03690
Sponsors and Collaborators
University of Alicante
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Responsible Party: Prof. Dr. Alejandro Martínez-Rodríguez, Assistant Professor, University of Alicante
ClinicalTrials.gov Identifier: NCT04158388    
Other Study ID Numbers: UA-2019-04-10
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante:
micronutrients
nutrition
therapy
chronic disease
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Tryptophan
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs