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Nature-based Sensory Stimulation on Pain Levels

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05017220
Recruitment Status : Completed
First Posted : August 23, 2021
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
José Manuel Pérez Mármol, 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

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Nature-based sensory stimuli Other: Control group intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Nature-based Sensory Stimulation on Pain in Women With Fibromyalgia: A Randomised Controlled Trial
Actual Study Start Date : July 15, 2021
Actual Primary Completion Date : August 31, 2021
Actual Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: Nature-based stimulation program
Participants will receive a single intervention with a duration of 30 minutes based on a multisensorial nature-based stimulation
Other: Nature-based sensory stimuli
A program based on stimulation using nature-based sensory stimuli will be implemented
Other Name: Biogenic sensory stimuli

Control intervention
Participants will be involved in a placebo task for 30 minutes
Other: Control group intervention
An activity based on a placebo intervention will be implemented




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05017220


Locations
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Spain
Faculty of Health Sciences
Granada, Spain, 18008
Universidad de Granada
Granada, Spain, 18008
Sponsors and Collaborators
Universidad de Granada
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Responsible Party: José Manuel Pérez Mármol, Principal Investigator / Associate professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT05017220    
Other Study ID Numbers: NBS in chronic pain patients
First Posted: August 23, 2021    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José Manuel Pérez Mármol, Universidad de Granada:
Fibromyalgia
Nature-based activities
Pain dimensions
Multisensory stimulation
Quantitative sensory testing
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases