NCT03710954

Brief Summary

This study aimed to analyze the stratification of pain levels through a mathematical model built using the diffuse joint theory and to investigate the relationship between range of motion and pain related aspects.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
535

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

October 16, 2018

Last Update Submit

February 24, 2019

Conditions

Pain

Keywords

Evaluation of painFuzzy systems theory

Outcome Measures

Primary Outcomes (1)

  • Numerical scale of pain

    Patients across this scale quantified their pain between 0 without pain, 1 to 4 mild pain, 5 moderate pain, 6 to 9 severe pain and 10 worst possible pain

    10 minutes

Secondary Outcomes (1)

  • Fuzzy Pain Scale

    10 minutes

Study Arms (1)

Experimental Group

EXPERIMENTAL

All the volunteers were evaluated through numerical evaluation of pain that assumes a subjective condition, the researcher showed the numerical scale of pain, being 0 without pain, 1 to 4 mild pain, 5 moderate pain, 6 to 9 severe pain and 10 worse pain possible pain, which was interpreted by the volunteer. In the Fuzzy Pain Scale, the evaluation of the range of motion was done where the evaluator used the goniometer (plastic instrument that verifies the angulation of the joint movement) and supplied the Fuzzy system with these data.

Diagnostic Test: Experimental Group

Interventions

Experimental GroupDIAGNOSTIC_TEST

All volunteers were evaluated by numerical pain scale and Fuzzy scale. This procedure was performed to compare the efficacy of the Fuzzy Scale demonstrating greater accuracy of quantification of skeletal muscle pain

Experimental Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details535 individuals with complaint of skeletal muscle pain
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Included in this study were male and female subjects
  • Age between 18 and 90 years
  • With complaint of skeletal muscle pain
  • Do not present cognitive deficit that makes the study impossible

You may not qualify if:

  • Individuals who did not agree to participate in the study
  • Volunteers with decreased range of motion
  • Volunteers without complaint of skeletal muscle pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 16, 2018

First Posted

October 18, 2018

Study Start

March 1, 2016

Primary Completion

September 20, 2016

Study Completion

June 30, 2017

Last Updated

February 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share