PainNCT03710954
Application and Comparison of Fuzzy Scale for the Evaluation of Pain Skeletal Muscle With the Numerical Pain Scale
A study testing Experimental Group in people with Pain, run by Universidade Cruzeiro do Sul.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 535 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals who did not agree to participate in the study
- Volunteers with decreased range of motion
- Volunteers without complaint of skeletal muscle pain
About this study
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.
Read the detailed description
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.
- Conditions
- Pain
- Being tested
- Experimental Group
- Keywords
- Evaluation of pain, Fuzzy systems theory
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Experimental Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 minutes
Secondary outcomes (1)
Fuzzy Pain Scale
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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Mar 2016
- Primary completion20 Sep 2016
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cruzeiro do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leandro Lazzareschi, University of Mogi das Cruzes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710954
- Sponsor's protocol ID
- 17258413.0.0000.5497
- Status last verified
- Feb 2019
- First submitted
- 16 Oct 2018
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Comparison of Fuzzy Scale for the Evaluation of Pain Skeletal Muscle With the Numerical Pain Scale
- ClinicalTrials.gov ID
- NCT03710954
- Acronym / sponsor ID
- 17258413.0.0000.5497
- Conditions
- Pain
- Keywords
- Evaluation of pain, Fuzzy systems theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 535 participants (actual)
- Lead sponsor
- Universidade Cruzeiro do SulUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 20 Sep 2016 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Diagnostic Test: Experimental GroupAll 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Individuals who did not agree to participate in the study
- Volunteers with decreased range of motion
- Volunteers without complaint of skeletal muscle pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupAll 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 | Diagnostic test | Experimental Group |
Primary outcome
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
1 secondary outcome
Fuzzy Pain Scale
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Pain, run by Universidade Cruzeiro do Sul.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical scale of pain (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.