Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04158388
• Other study ID #: UA-2019-04-10
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: October 10, 2019

Study information

• Verified date: May 2020
• Source: University of Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 10, 2019
• Est. primary completion date: October 9, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
Spain	University of Alicante	Alicante	San Vicente Del Raspeig

Sponsors (1)

Lead Sponsor	Collaborator
University of Alicante

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Quality	Sleep Quality assessment: Athenas Insomnia Scale.	4 - 16 weeks
Primary	Anxiety trait	Anxiety trait assessment: Stay Trait Anxiety Inventory.	4 - 16 weeks
Primary	Mood state	Mood state assessment: Profile of Mood State inventory.	4 - 16 weeks
Primary	Fatigue severity	Fatigue severity assessment: Fatigue Severity Scale	4 - 16 weeks
Primary	Pain perception	Pain perception assessment: Visual Analogical Scale	4 - 16 weeks
Primary	Sleep quality	Sleep quality assessment: Pittsburgh Sleep Quality Index	4 - 16 weeks
Secondary	Body composition	Body composition assessment trough bioimpedance.	4 - 16 weeks