Health Condition 1: M545- Low back pain
Conditions
Interventions
Intervention1: Conventional Treatment + Dry Needling (CT+DN) Group, also known as Add-on group: In addition to the treatment prescribed for the Conventional Treatment (CT) group, patients in this grou
Sponsors
Deshbandhu Pachauri
Eligibility
Inclusion criteria
Inclusion criteria: Subject diagnosed with myofascial low back pain, characterized by the presence of trigger points and localized muscle pain/tenderness; Subject experiencing myofascial pain symptoms (e.g., muscle pain, tenderness) for at least 3 months; Subject has a baseline Numeric Pain Rating Scale (NPRS) score of 4 or higher; Subject has stable medical condition that is not expected to significantly deteriorate during the study period in the opinion of the investigator; Woman who is postmenopausal for 12 months or less before screening (unless permanently sterilized or using an IUD) must have a negative urine pregnancy test prior to the randomization visit; Subject is willing to comply with all aspects of the study protocol, including attending scheduled appointments, completing study assessments and adhering to applicable restrictions; Subject has provided informed consent to participate in the study; No spine/lumbar surgery in the last 6 months
Exclusion criteria
Exclusion criteria: Subject presenting sharp, shooting pain radiating to lower limbs (associated with tingling and numbness) along with back pain; Subject with active systemic or local infection(s); Subject with bleeding disorder(s) or on anticoagulant medication(s); Subject currently experiencing or with a history of psychiatric condition, cognitive impairment, neurological disorder, or other clinically significant disease or abnormality (such as congestive heart failure, uncontrolled hypertension, myocardial infarction, stroke, uncontrolled coronary artery disease, arrhythmias, uncontrolled diabetes, convulsive disorders etc.) which, in the opinion of the investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study, or would interfere with their ability to complete the study, or would hinder their ability to understand the study procedures, or would impact their compliance with study assessments or treatment protocols, or would affect pain perception; Subject with a history of allergy or hypersensitivity to Etoricoxib, Thiocolchicoside or Diclofenac; Subject with a history of alcohol or substance abuse Woman who is pregnant or planning pregnancy during the course of the study; Subject who is currently participating in or has participated in any other clinical trial within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Pain Intensity using Numeric Pain Rating Scale (NPRS)Timepoint: Screening, Day 0, 3, 7, 10, 14, 28, 56, 84, 168 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Pressure Pain Threshold (PPT)Timepoint: Day 0, 3, 7, 10, 14, 28, 56, 84, 168;Change in Range of Motion (ROM)Timepoint: Day 0, 3, 7, 10, 14, 28, 56, 84, 168;Change in Disability Rating Index (DRI)Timepoint: Day 0, 7, 14, 28, 56, 84, 168;Change in Pain and Sleep Questionnaire (PSQ) scoreTimepoint: Day 0, 7, 14, 28, 56, 84, 168;Change in Quality of Life Scale (QOLS) scoreTimepoint: Day 0, 7, 14, 28, 56, 84, 168;Change in Patients Global Impression of Change (PGI-C) scaleTimepoint: Day 3, 7, 14, 28, 56, 84, 168;Change in Hospital Anxiety and Depression Scale (HADS)Timepoint: Day 0, 7, 14, 28, 56, 84, 168 | — |
Countries
India
Contacts
Public ContactDeshbandhu Pachauri
MIT-World Peace University (MIT-WPU)
Outcome results
None listed