Nature-based Sensory Stimulation on Pain Levels

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: Nature-based sensory stimuli; Other: Control group intervention

• Registration Number: NCT05017220
• Lead Sponsor: Universidad de Granada

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2021-07-05
• Study Start: 2021-07-15
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-23
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nature-based stimulation program	Nature-based sensory stimuli	Participants will receive a single intervention with a duration of 30 minutes based on a multisensorial nature-based stimulation
Control intervention	Control group intervention	Participants will be involved in a placebo task for 30 minutes

Primary Outcome Measures

Name	Time	Method
Pain intensity	Change from baseline pain intensity after 30 minutes	Clinical pain intensity assessed by an 11-points Numeric Rating Scale (NRS-11) ranging from 0 to 10
Cold pain thresholds	Change from baseline cold pain thresholds after 30 minutes	Cold pressor test will be used
Punctate mechanical hyperalgesia	Change from baseline mechanical hyperalgesia after 30 minutes	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
Wind-up phenomenon	Change from baseline temporal summation of pain perception after 30 minutes	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.
Pressure pain thresholds	Change from baseline pressure pain thresholds after 30 minutes	The minimum pressure force which induces pain when pressure is applied on tissues is regarded as the pressure pain threshold

Trial Locations

Locations (2)

Faculty of Health Sciences; 🇪🇸 Granada, Spain

Universidad de Granada; 🇪🇸 Granada, Spain