CTRI/2024/12/078670 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On:
27/12/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Physiotherapy (Not Including YOGA) Other (Specify) [Dry Needling]
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Assessing the Benefits of Dry Needling for Low Back Pain When Combined with Regular Treatment
Scientific Title of Study
Investigating Dry Needling as an Add-on Therapy to Conventional Treatment for Myofascial Low Back Pain: A Randomized Controlled Trial
Trial Acronym
DryNATiMP
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Deshbandhu Pachauri
Designation
Research Scholar
Affiliation
MIT-World Peace University (MIT-WPU)
Address
Pharmacognosy Research Lab, Department of Pharmaceutical Sciences, School of Health Sciences and Technology, Dr. Vishwanath Karad MIT-World Peace University (MIT-WPU), Survey No, 124, Paud Rd, Kothrud
Pune MAHARASHTRA 411038 India
Phone
Fax
Email
1102200129@mitwpu.edu.in
Details of Contact Person Scientific Query
Name
Deshbandhu Pachauri
Designation
Research Scholar
Affiliation
MIT-World Peace University (MIT-WPU)
Address
Pharmacognosy Research Lab, Department of Pharmaceutical Sciences, School of Health Sciences and Technology, Dr. Vishwanath Karad MIT-World Peace University (MIT-WPU), Survey No, 124, Paud Rd, Kothrud
Pune MAHARASHTRA 411038 India
Phone
9226194552
Fax
Email
1102200129@mitwpu.edu.in
Details of Contact Person Public Query
Name
Deshbandhu Pachauri
Designation
Research Scholar
Affiliation
MIT-World Peace University (MIT-WPU)
Address
Pharmacognosy Research Lab, Department of Pharmaceutical Sciences, School of Health Sciences and Technology, Dr. Vishwanath Karad MIT-World Peace University (MIT-WPU), Survey No, 124, Paud Rd, Kothrud
MAHARASHTRA 411038 India
Phone
9226194552
Fax
Email
1102200129@mitwpu.edu.in
Source of Monetary or Material Support
Sigma Spine and Pain Clinic, 4th floor, Shree Bhagwati Suvarna, Pan Card Club Rd, Baner, Pune, Maharashtra 411045
Primary Sponsor
Name
Deshbandhu Pachauri
Address
Pharmacognosy Research Lab, Department of Pharmaceutical Sciences, School of Health Sciences and Technology, Dr. Vishwanath Karad MIT-World Peace University (MIT-WPU), Survey No, 124, Paud Rd, Kothrud
Type of Sponsor
Other [Self]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Priya Rathi
Sigma Spine and Pain Clinic
4th floor, Shree Bhagwati Suvarna, Pan Card Club Rd, Baner Pune MAHARASHTRA
9168877943
priyapdb@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Skinovate Independent Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: M545||Low back pain,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Conventional Treatment (CT) Group, also known as Control group
Post randomization, patients to follow prescribed pharmacotherapy i.e., Fixed dose combination tablets (Composition is Etoricoxib 60 mg + Thiocolchicoside 4 mg) two times a day for first 2 weeks and prescribed physiotherapy daily until Day 168.
Etoricoxib is a selective COX-2 inhibitor used to reduce pain and inflammation, typically used for musculoskeletal pain.
Thiocolchicoside is a muscle relaxant used to relieve muscle spasms and discomfort associated with back pain.
Physiotherapy improves mobility, reduces pain, and restores function.
Intervention
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 group will receive 5 dry needling sessions over the first 2 weeks (scheduled on Day 0, Day 3, Day 7, Day 10, and Day 14).
Dry Needling involves the insertion of thin needles into specific muscle trigger points to relieve pain, reduce muscle tightness, and improve range of motion.
Dry needling is expected to complement the pharmacotherapy and physiotherapy treatments, targeting specific pain points and muscle stiffness that may contribute to low back pain.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
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
ExclusionCriteria
Details
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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Change in Pain Intensity using Numeric Pain Rating Scale (NPRS)
Screening, Day 0, 3, 7, 10, 14, 28, 56, 84, 168
Secondary Outcome
Outcome
TimePoints
Change in Pressure Pain Threshold (PPT)
Day 0, 3, 7, 10, 14, 28, 56, 84, 168
Change in Range of Motion (ROM)
Day 0, 3, 7, 10, 14, 28, 56, 84, 168
Change in Disability Rating Index (DRI)
Day 0, 7, 14, 28, 56, 84, 168
Change in Pain and Sleep Questionnaire (PSQ) score
Day 0, 7, 14, 28, 56, 84, 168
Change in Quality of Life Scale (QOLS) score
Day 0, 7, 14, 28, 56, 84, 168
Change in Patients Global Impression of Change (PGI-C) scale
Day 3, 7, 14, 28, 56, 84, 168
Change in Hospital Anxiety and Depression Scale (HADS)
Day 0, 7, 14, 28, 56, 84, 168
Target Sample Size
Total Sample Size="140" Sample Size from India="140" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 4
Date of First Enrollment (India)
06/01/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Closed to Recruitment of Participants
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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.