NCT04158388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

October 14, 2019

Last Update Submit

May 8, 2020

Conditions

Fibromyalgia

Keywords

micronutrientsnutritiontherapychronic disease

Outcome Measures

Primary Outcomes (6)

  • Sleep Quality

    Sleep Quality assessment: Athenas Insomnia Scale.

    4 - 16 weeks

  • Anxiety trait

    Anxiety trait assessment: Stay Trait Anxiety Inventory.

    4 - 16 weeks

  • Mood state

    Mood state assessment: Profile of Mood State inventory.

    4 - 16 weeks

  • Fatigue severity

    Fatigue severity assessment: Fatigue Severity Scale

    4 - 16 weeks

  • Pain perception

    Pain perception assessment: Visual Analogical Scale

    4 - 16 weeks

  • Sleep quality

    Sleep quality assessment: Pittsburgh Sleep Quality Index

    4 - 16 weeks

Secondary Outcomes (1)

  • Body composition

    4 - 16 weeks

Study Arms (4)

EXPERIMENTAL DIET GROUP

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

CONTROL GROUP

OTHER
Other: Isocaloric diet

EXPERIMENTAL MASSAGE GROUP

EXPERIMENTAL

That group received moderate pressure digital manual therapy.

Other: Manual therapy

EXPERIMENTAL PLACEBO GROUP

EXPERIMENTAL

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

Other: Placebo therapy

Interventions

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

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

EXPERIMENTAL DIET GROUP
Isocaloric dietOTHER

That group eaten isocaloric diet plan based on Mediterranean diet.

CONTROL GROUP
Manual therapyOTHER

That group received moderate pressure digital manual therapy.

EXPERIMENTAL MASSAGE GROUP
Placebo therapyOTHER

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

EXPERIMENTAL PLACEBO GROUP

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alicante

Alicante, San Vicente Del Raspeig, 03690, Spain

Location

MeSH Terms

Conditions

FibromyalgiaChronic Disease

Interventions

TryptophanMagnesiumMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialMetals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetalsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 14, 2019

First Posted

November 8, 2019

Study Start

May 1, 2019

Primary Completion

October 9, 2019

Study Completion

October 10, 2019

Last Updated

May 12, 2020

Record last verified: 2020-05

Locations

ES(1)