Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia

Overview

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.

Full Title of Study: “Effects of Nutritional Strategies or Manual Therapies on Physical and Psychological Parameters in Women With Fybromyalgia.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 9, 2019

Interventions

  • 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
  • Other: Isocaloric diet
    • That group eaten isocaloric diet plan based on Mediterranean diet.
  • Other: Manual therapy
    • That group received moderate pressure digital manual therapy.
  • Other: Placebo therapy
    • That group was treated with a US (in off mode) without conductive gel.

Arms, Groups and Cohorts

  • Experimental: EXPERIMENTAL DIET GROUP
  • Other: CONTROL GROUP
  • Experimental: EXPERIMENTAL MASSAGE GROUP
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Sleep Quality
    • Time Frame: 4 – 16 weeks
    • Sleep Quality assessment: Athenas Insomnia Scale.
  • Anxiety trait
    • Time Frame: 4 – 16 weeks
    • Anxiety trait assessment: Stay Trait Anxiety Inventory.
  • Mood state
    • Time Frame: 4 – 16 weeks
    • Mood state assessment: Profile of Mood State inventory.
  • Fatigue severity
    • Time Frame: 4 – 16 weeks
    • Fatigue severity assessment: Fatigue Severity Scale
  • Pain perception
    • Time Frame: 4 – 16 weeks
    • Pain perception assessment: Visual Analogical Scale
  • Sleep quality
    • Time Frame: 4 – 16 weeks
    • Sleep quality assessment: Pittsburgh Sleep Quality Index

Secondary Measures

  • Body composition
    • Time Frame: 4 – 16 weeks
    • Body composition assessment trough bioimpedance.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 40 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alicante
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof. Dr. Alejandro Martínez-Rodríguez, Assistant Professor – University of Alicante

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