Nature-based Sensory Stimulation on Pain Levels

Universidad de Granada42 enrolled

Overview

This randomized controlled trial aims to evaluate the effect of a single session intervention based on a nature-based stimulation program in patients with fibromyalgia

All participants will continue to receive their usual pharmacological treatment as previously established by the Andalusian Public Health System. The intervention will comprise interaction tasks with biotic and abiotic agents for 30 minutes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fibromyalgia

Interventions

Nature-based sensory stimuliOTHER

A program based on stimulation using nature-based sensory stimuli will be implemented

Control group interventionOTHER

An activity based on a placebo intervention will be implemented

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of fibromyalgia syndrome (ACR criteria 2016). * Chronic widespread musculoskeletal pain symptoms (\>1 location using the Widespread Pain Index). * High-intensity pain (VAS ≥ 4), at least 3 days a week for the previous 3 months. * If currently taking analgesic or psychotropic medications, they had to be stabilised for four or more weeks before the study enrolment * Over 18 and less than 65 years old (labour active). * Ability to speak and understand English or Spanish. Exclusion Criteria: * Acute or temporal pain * Severe cognitive impairment, detected by the Mini-Mental State Examination (score \<24 out of 30 points) * Severe mental disorders in acute phase or symptomatic phase * Behavioural alterations as this may interfere in their participation * Severe intellectual disability * Other severe or medically unstable diseases interfering with the project participation * Co-occurrence of neuropathic pain * Other disorders that may cause pain * Pregnant or breast-feeding * Drug abuse within the past year.

Locations (2)

Faculty of Health Sciences

Granada, Spain

Universidad de Granada

Granada, Spain

Outcomes

Primary Outcomes

Pain intensity

Clinical pain intensity assessed by an 11-points Numeric Rating Scale (NRS-11) ranging from 0 to 10

Time frame: Change from baseline pain intensity after 30 minutes

Cold pain thresholds

Cold pressor test will be used

Time frame: Change from baseline cold pain thresholds after 30 minutes

Punctate mechanical hyperalgesia

Semmes-Weinstein monofilament (Aesthesio® Precise Tactile Sensory Evaluator, DanMic Global, LLC, San Jose, CA, USA) calibrated to bend at 300 gm (2940 mN; size 6.65; 0.1143 cm in diameter) of pressure with a response-dependent method will be used

Time frame: Change from baseline mechanical hyperalgesia after 30 minutes

Wind-up phenomenon

Wind-up is a frequency- and intensity-dependent increase in the excitability of dorsal horn neuron that results in a temporal summation of pain perception.

Time frame: Change from baseline temporal summation of pain perception after 30 minutes

Pressure pain thresholds

The minimum pressure force which induces pain when pressure is applied on tissues is regarded as the pressure pain threshold

Time frame: Change from baseline pressure pain thresholds after 30 minutes

Data from ClinicalTrials.gov

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