The Effects of Nature-based Sensory Stimulation on Pain in Women With Fibromyalgia: A Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Universidad de Granada
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Pain intensity
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
José Manuel Pérez Mármol
Principal Investigator / Associate professor
Universidad de Granada
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Pain intensity
Time Frame: 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
Time Frame: Change from baseline cold pain thresholds after 30 minutes
Cold pressor test will be used
Punctate mechanical hyperalgesia
Time Frame: 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
Time Frame: 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
Time Frame: 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