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Completed

NCT Number: NCT04158388

Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Chronic Disease Disease Attributes Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alicante

Alicante, San Vicente Del Raspeig, 03690, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mediterranean-diet enriched with a higher dose of tryptophan and magnesium

Other

That gruop eaten at both breakfast and dinner from walnuts (3-5 units), as food with high values of tryptophan and magnesium

isocaloric diet

Other

That group eaten isocaloric diet plan based on Mediterranean diet.

Manual therapy

Other

That group received moderate pressure digital manual therapy.

Placebo therapy

Other

That group was treated with a US (in off mode) without conductive gel.

Primary outcomes

  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 outcomes

  1. Body composition

    Time frame: 4 - 16 weeks

    Body composition assessment trough bioimpedance.

Sponsors and collaborators

Lead sponsor

University of Alicante

Other

Registry information

Official study title

Effects of Nutritional Strategies or Manual Therapies on Physical and Psychological Parameters in Women With Fybromyalgia.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2019
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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