Clinical trial NCT06791434: Assessing the Benefits of Dry Needling for Low Back Pain When Combined with Regular Treatment
Official title: Investigating Dry Needling As an Add-on Therapy to Conventional Treatment for Myofascial Low Back Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Low Back Pain
Lead sponsor: Dr. Vishwanath Karad MIT World Peace University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed clinical study aims to evaluate the effectiveness and safety of adding Dry Needling (DN) to Conventional Treatment (CT) for patients with Myofascial Low Back Pain (MLBP). MLBP is a widespread musculoskeletal condition that causes localized pain, muscle tenderness, and functional limitations, significantly affecting the quality of life and productivity of those affected. Conventional Treatment for MLBP typically combines pharmacotherapy (e.g., NSAIDs, muscle relaxants) and physiotherapy. Dry Needling, an emerging treatment that targets myofascial trigger points with fine needles, has demonstrated promise in relieving pain and improving functional outcomes. However, no study has yet evaluated the combined effects of CT and DN. This randomized, open-label, controlled trial will involve 140 patients (70 per group) and compare the effects of CT alone versus CT combined with DN. The primary objective is to assess the change in pain intensity, while secondary objectives include improvements in pressure pain threshold, range of motion, disability, quality of life, sleep, anxiety, and depression scores.

Safety will also be assessed based on adverse events and vital sign changes. The study will span 24 weeks, with 11 scheduled visits for each participant. Data analysis will be conducted to determine the added benefit of DN as an adjunctive therapy to CT, with the ultimate goal of improving treatment strategies and patient outcomes for MLBP.


Eligibility 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

Primary outcomes:
measure: Change in Pain Intensity using Numeric Pain Rating Scale (NPRS)
timeFrame: Screening, Day 0, 3, 7, 10, 14, 28, 56, 84, 168
Secondary outcomes:
measure: Change in Pressure Pain Threshold using Algometer
timeFrame: Day 0, 3, 7, 10, 14, 28, 56, 84, 168
measure: Change in Range of Motion
timeFrame: Day 0, 3, 7, 10, 14, 28, 56, 84, 168
measure: Change in Physical Disability using Salen's Disability Rating Index (DRI)
timeFrame: Day 0, 7, 14, 28, 56, 84, 168
measure: Change in Pain and Sleep using Pain and Sleep Questionnaire (PSQ-3)
timeFrame: Day 0, 7, 14, 28, 56, 84, 168
measure: Change in Quality of Life Scale Score using Burckhardt's Quality of Life Scale (QOLS)
timeFrame: Day 0, 7, 14, 28, 56, 84, 168
measure: Change in Patients Impression using Patients' Global Impression of Change (PGI-C) Scale
timeFrame: Day 3, 7, 14, 28, 56, 84, 168
measure: Change in Severity of Anxiety and Depression Symptoms using Hospital Anxiety and Depression Scale (HADS)
timeFrame: Day 0, 7, 14, 28, 56, 84, 168
Other outcomes:
Locations:
city: Pune
country: India
facility: Sigma Spine and Pain Clinic
state: Maharashtra
Study officials:
References:
citation: Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. doi: 10.1007/s11916-006-0058-3.
citation: Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.