NCT04158388

Effects of Nutritional Strategies or Manual Therapies in Women With Fibromyalgia

Completed NA Last updated 12 May 2020

What this trial tests

NA trial testing Mediterranean-diet enriched with a higher dose of tryptophan and magnesium in Fibromyalgia in 24 participants. Completed in 10 October 2019.

Timeline

1 May 2019

Primary endpoint
9 October 2019

10 October 2019

Quick facts

Lead sponsor	University of Alicante
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	24
Start date	1 May 2019
Primary completion	9 October 2019
Estimated completion	10 October 2019
Sites	1 location across Spain

Drugs / interventions tested

• Mediterranean-diet enriched with a higher dose of tryptophan and magnesium
• Isocaloric diet
• Manual therapy
• Placebo therapy

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

University of Alicante

Who can join

Adults 40 to 60, female only, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychological and Sleep Effects of Tryptophan and Magnesium-Enriched Mediterranean Diet in Women with Fibromyalgia.
   Martínez-Rodríguez A, Martínez-Rodríguez A, Rubio-Arias JÁ, Ramos-Campo DJ, et al · · 2020 · cited 42× · PMID 32224987 · DOI 10.3390/ijerph17072227
2. Effects of Manual Therapy on Fatigue, Pain, and Psychological Aspects in Women with Fibromyalgia.
   Nadal-Nicolás Y, Rubio-Arias JÁ, Martínez-Olcina M, Reche-García C, et al · · 2020 · cited 34× · PMID 32604939 · DOI 10.3390/ijerph17124611