Low Back Pain
Conditions
Interventions
Men and women ages between 18 and 65 years diagnosed with pain: cervical (neck pain), dorsal pain (back pain) and lumbar pain (low back pain), presenting at least one type of intensity pain, from mild
Device
eletromagnético
Infravermelho Longo
Sponsors
kenko patto photon industria e comercio ltda
Allergisa Pesquisa Dermato-Cosmética Ltda
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: The research participants included on this research must satisfied the inclusion criteria: present capability of provide in written, in person, signed and dated the free and enlightened consent to participate on the research, in accordance with the Document of the Americas and to follow the guidelines and regulations applicable to the study procedures; present the ability to read, understand and complete the questionnaires applied to the study; be mentally empowered to provide your consent and meet all the study requirements; men and women aged between 18 and 65 years; presence of pain of mild to moderate intensity related to pain, in at least one type of pain according to a visual analog scale (VAS) of and considering the following intensity criterion: score 1 to 3 = mild pain; score 4 to 6 = moderate pain.
Exclusion criteria
Exclusion criteria: The research participants, that will be included on this research, may not have the following exclusion criteria: research participants which participated previously on any clinical research involving products under investigation within 30 days before randomization; history of non-adherence to previous studies; people who are directly involved in the study; use of opioids 07 days before the randomization visit; use of intra-articular steroids or hyaluronic acid injection or other immunosuppressive medication 3 (three) months before the randomization visit; current pregnancy or lactation during 3 months before the study begins; imminent need for primary surgical treatment; known history of gastrointestinal diseases, urological or current pelvic inflammatory disease, that may cause symptoms of pelvic pain, such as endometriosis; cervical and lumbar pain caused by neurological symptoms; history or suspicion of cancer, such as: Primary tumors (vertebra or spine), Metastatic vertebral tumors (mostly on breast, lungs or prostate); significant systemic mental or chronic illness, that may interfere with the pain evaluation or the ability to complete the study; grade 3 obesity (BMI greater than or equal to 40 kg/m2); infectious diseases such as (eg, discitis, epidural abscess, osteomyelitis); patients with diseases such as herniated disc, osteoid osteoma; spondyloarthropathies, fibromyalgia, compression fracture, osteoarthritis, among other diseases of specific structural injuries; use of pacemaker, possibility of using defibrillator; undergoing hemodialysis sessions; use of magnetic mattresses and / or equipment that have the same or similar operating principle as the investigational product; presence of neoplastic disease with indication for systemic chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aimed to evaluate superiority, regarding the effectiveness of the KenkoBio equipment versus placebo, as well as evaluating safety in different treatment groups, in research participants diagnosed with low back pain with mild to moderate pain;Aimed to evaluate superiority, regarding the effectiveness of the KenkoBio equipment versus placebo, as well as evaluating safety in different treatment groups, in research participants diagnosed with cervical pain with mild to moderate pain | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain improvement, through the evaluation of the visual analog scale (VAS) filled in by the participant of the research over 4 weeks, with 2 weeks of treatment and 2 weeks of maintenance ;Improvement of pain, through the visual analog scale (VAS) completed by the doctor over 04 weeks, with 2 weeks of treatment and 2 weeks of maintenance ;Improvement in quality of life, through the evaluation of the Short-Form 36 questionnaire (SF36) and its dimensions throughout the study ;Evaluation of superficial blood perfusion over 4 weeks of treatment. (Thermography) | — |
Countries
Brazil
Contacts
Public ContactMauro Junior
Allergisa Pesquisa Dermato-Cosmética Ltda
Outcome results
None listed