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Nature-based Sensory Stimulation on Pain Levels

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Nature-based sensory stimuli

Control group intervention

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Nature-based activities, Pain dimensions, Multisensory stimulation, Quantitative sensory testing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Faculty of Health Sciences
Universidad de Granada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Nature-based stimulation program

Control intervention

Arm Description

Participants will receive a single intervention with a duration of 30 minutes based on a multisensorial nature-based stimulation

Participants will be involved in a placebo task for 30 minutes

Outcomes

Primary Outcome Measures

Pain intensity

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

Cold pain thresholds

Cold pressor test will be used

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

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.

Pressure pain thresholds

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05017220

First Posted

July 5, 2021

Last Updated

September 30, 2021

Sponsor

Universidad de Granada

1. Study Identification

Unique Protocol Identification Number

NCT05017220

Brief Title

Nature-based Sensory Stimulation on Pain Levels

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

July 15, 2021 (Actual)

Primary Completion Date

August 31, 2021 (Actual)

Study Completion Date

August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Fibromyalgia, Nature-based activities, Pain dimensions, Multisensory stimulation, Quantitative sensory testing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nature-based stimulation program

Arm Type

Experimental

Arm Description

Participants will receive a single intervention with a duration of 30 minutes based on a multisensorial nature-based stimulation

Arm Title

Control intervention

Arm Type

Other

Arm Description

Participants will be involved in a placebo task for 30 minutes

Intervention Type

Other

Intervention Name(s)

Nature-based sensory stimuli

Other Intervention Name(s)

Biogenic sensory stimuli

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Control group intervention

Intervention Description

An activity based on a placebo intervention will be implemented

Primary Outcome Measure Information:

Title

Pain intensity

Description

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

Title

Cold pain thresholds

Description

Cold pressor test will be used

Time Frame

Change from baseline cold pain thresholds after 30 minutes

Title

Punctate mechanical hyperalgesia

Description

Time Frame

Change from baseline mechanical hyperalgesia after 30 minutes

Title

Wind-up phenomenon

Description

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

Title

Pressure pain thresholds

Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Faculty of Health Sciences

City

Granada

ZIP/Postal Code

18008

Country

Spain

Facility Name

Universidad de Granada

City

Granada

ZIP/Postal Code

18008

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

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Nature-based Sensory Stimulation on Pain Levels

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