Evaluating Dry Needling for Low Back Pain with Conventional Treatment
Investigating Dry Needling As an Add-on Therapy to Conventional Treatment for Myofascial Low Back Pain: a Randomized Controlled Trial
This study is testing if adding dry needling to regular treatment can help people with myofascial low back pain feel less pain and improve their overall satisfaction.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Dr. Vishwanath Karad MIT World Peace University Academic / other |
| Locations | 1 site (Pune, Maharashtra) |
| Trial ID | NCT06791434 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the effectiveness and safety of combining Dry Needling (DN) with Conventional Treatment (CT) for patients suffering from Myofascial Low Back Pain (MLBP). The trial will involve 140 participants, randomly assigned to receive either CT alone or CT plus DN, with the primary focus on measuring changes in pain intensity. Secondary objectives will evaluate functional outcomes and overall patient satisfaction. The study seeks to fill a gap in existing research by exploring the combined effects of these treatments.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with myofascial low back pain for at least three months, experiencing significant pain and willing to comply with study protocols.
Not a fit: Patients who have undergone spine or lumbar surgery in the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for patients suffering from chronic low back pain.
How similar studies have performed: While Dry Needling has shown promise in other contexts, this specific combination with Conventional Treatment has not been previously evaluated.
Eligibility criteria
Show full inclusion / exclusion 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: * 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
Where this trial is running
Pune, Maharashtra
- Sigma Spine and Pain Clinic — Pune, Maharashtra, India (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.