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Completed

NCT Number: NCT05017220

Nature-based Sensory Stimulation on Pain Levels

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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences, Granada, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nature-based sensory stimuli

Other

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

Other names: Biogenic sensory stimuli

Control group intervention

Other

An activity based on a placebo intervention will be implemented

Primary outcomes

  1. 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

  2. Cold pain thresholds

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

    Cold pressor test will be used

  3. 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

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

The Effects of Nature-based Sensory Stimulation on Pain in Women With Fibromyalgia: A Randomised Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 23, 2021
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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