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Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia

NCT04158388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-05-12

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

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.

Sponsors & Collaborators

  • University of Alicante

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2019-10-09
Completion
2019-10-10

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04158388 on ClinicalTrials.gov