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Completed

NCT Number: NCT03710954

Application and Comparison of Fuzzy Scale for the Evaluation of Pain Skeletal Muscle With the Numerical Pain Scale

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The incidence of pain is due to traumatic actions, surgical interventions, new habits of life, increased longevity of the individuals and the reduction of the tolerance of the suffering by the man. Musculoskeletal pain is more evident in adult individuals, being the main cause of chronic pain throughout society, generating an impact on the quality of life, interfering in the daily activity of 30 to 50% of the patients. Pain measurement can be divided into four levels, which include the nominal, the ordinal, the interval and the ratio, with both one-dimensional and multidimensional versions. In the health area, diagnosis and treatment of diseases involve various levels of imprecision and uncertainties. A single disease or symptom may manifest totally differently in different patients and with varying degrees of severity. These effects usually generate many uncertainties and inaccuracies affecting the interpretations of the exams and the diagnosis, as well as the treatment. Fuzzy Systems Theory, also known as nebulous logic, is used to interpret the approximate mode of human reasoning, to take it to a numerical format and to obtain answers in an environment of uncertainties that serve as a subsidy to decision-making . A Fuzzy system based on Fuzzy logic. It can also be considered as a kind of expert, knowledge-based system. The development of the proposed Fuzzy Scale for Skeletal Muscle Pain Evaluation used the Mamdani method that allowed the representation of specialist knowledge (s) to construct the rule base. The construction of this system was based on the numerical scale of pain adopted and spread worldwide, and on the range of motion represented by the action of the muscles and articular components of the human body. The diffuse model proposed by the Fuzzy Scale for Muscle Skeletal Pain Evaluation uses 25 rules using binary XOR logic. For the volunteer tests, the proposed model was a non-randomized single intervention transverse study to analyze and compare the model of diffuse pain evaluation with the numerical pain scale performed with 535 volunteers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Experimental Group

Diagnostic 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

Primary outcomes

  1. Numerical scale of pain

    Time frame: 10 minutes

    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

Secondary outcomes

  1. Fuzzy Pain Scale

    Time frame: 10 minutes

    The evaluation of the range of motion was done by an evaluator who used a goniometer (plastic instrument that verifies the angulation of joint movement) according to: Spine-cervical Flexion: 0-65°; Cervical extension: 0-50°; Shoulder-horizontal Adduction: 0-40°; Internal rotation: 0-90°; External rotation: 0-90 °; Flexion: 0-145°; Extension: 145-0°; Elbow: Pronation: 0-90°; Supination: 0-90°; Flexion: 0-90°; Fist-extension: 0-75°; Radial deviation: 0-25ø; Ulnar deviation: 0-45°; Flexion: 0-95 °; Extension: 0-35 °; Lumbar spine-lateral flex: 0-40 °; Trunk rotation: 0-35 °; Flexion (knee flexion): 0-125°; Flexion (knee extended): 0-90°; Extension: 0-10°; Hip-external rotation: 0-45°; Abduction: 0-45°; Adduction: 0-15°; Flexion: 0-140°; Knee-Bending: 0-140°; Ankle-Dorsiflexion: 0-20°; Plant flexion: 0-45°. Supplying the Fuzzy Pain Analysis System.

Sponsors and collaborators

Lead sponsor

Universidade Cruzeiro do Sul

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Oct 18, 2018
Registry last updated
Feb 26, 2019

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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