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CTRI Number  CTRI/2022/09/045625 [Registered on: 19/09/2022] Trial Registered Prospectively
Last Modified On: 18/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Physiotherapy, dry needling and stay active advice for patients with low back pain. 
Scientific Title of Study   Impact of physiotherapy, dry needling and stay active advice on patients with low back pain  
Trial Acronym  Not applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohammad Ali 
Designation  Head of Physiotherapy and Rehabilitation Department 
Affiliation  Uttara Adhunik Medical College and Hospital 
Address  Department of Physiotherapy and Rehabilitation, Room no-01.



1230
Other 
Phone  01715043533  
Fax    
Email  alibup2018@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mohammad Ali 
Designation  Head of Physiotherapy and Rehabilitation Department 
Affiliation  Uttara Adhunik Medical College and Hospital 
Address  Department of Physiotherapy and Rehabilitation, Room no-01.



1230
Other 
Phone  01715043533  
Fax    
Email  alibup2018@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mohammad Ali 
Designation  Head of Physiotherapy and Rehabilitation Department 
Affiliation  Uttara Adhunik Medical College and Hospital 
Address  Department of Physiotherapy and Rehabilitation. Room no-01.



1230
Other 
Phone  01715043533  
Fax    
Email  alibup2018@gmail.com  
 
Source of Monetary or Material Support  
Dhaka Pain Physiotherapy & Rehabilitation Centre(DPRC) ltd 12/1, Shaymoli, Dhaka-1207, Bangladesh 
 
Primary Sponsor  
Name  Hasna Hena Pain Physiotherapy and Public Health Research Center 
Address  House-07, Shayesta Khan Avenue, Sector-04, Uttara, Dhaka-1230, Bangladesh 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
Dhaka Pain Physiotherapy Rehabilitation CentreDPRC ltd  12/1, Ring road, Shaymoli, Dhaka-1207 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Md Shafiullah Prodhania  Dhaka Pain Physiotherapy and Rehabilitation Center  Department of Physiotherapy and Rehabilitation. Room no-01. 12/1, Shaymoli, Dhaka-1207, Bangladesh

 
8801989000222

shafiullahprodhan@gmail.com 
Mohammad Ali  Hasna Hena Pain, Physiotherapy and Public Health Research Center  Department of Physiotherapy and Rehabilitation. Room no-03. House 7, Shayestakhan Avenue, Sector 04, Uttara, Dhaka-1230, Bangladesh

 
8801715043533

alibup2018@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institute of Physiotherapy, Rehabilitation and Research (IPRR)  Approved 
Institute of Physiotherapy, Rehabilitation and Research (IPRR)  Approved 
Institute of Physiotherapy, Rehabilitation and Research (IPRR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Physiotherapy, dry needling and advice  Patients will be divided into two groups. Group 1 will be given only physiotherapy intervention. However, group 2 will be provided dry needling adjunct to the standard physiotherapy. Patients of both groups will receive 21 sessions of treatment. Pain and related factors will be evaluated in the baseline, after 21 days and 3 months after the intervention started. 
Comparator Agent  Physiotherpy and physiotherapy plus dry needling  Group one will receive only physiotherapy. Group two will receive physiotherapy plus dry needling. Both the groups will receive 21 aession of treatment and will be evaluated at baseline, after 21 days and 90 days from the treatment start.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patient with low back pain 
 
ExclusionCriteria 
Details  Patients with cancer pain, pain due to rheumatoid arthritis and pregnant women.  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Dates of Birth or day of the Week 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain and status of disability   At baseline and after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Back beliefs and mental health  At baseline and after treatment 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="0" 
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   N/A 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/09/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Low back pain (LBP) is a pervasive problem that individuals encounter at a particular time in their lives. Additionally, its substantial mass soundness and healthiness is an issue in industrialized provinces which prompts individual torment, absenteeism from employment, and, in some cases, primaeval retirement. Evaluating the commonness of LBP is problematic as the cumulative occurrences of earliest episodes of LBP are formerly eminent by the primaeval adolescent, and indications are susceptible to recur over time. Considering the familiar pathology that is difficult to treat effectively, LBP epitomizes a high financial burden for the community and the health system. It is considered one of the leading grounds of primary and specialized care consultations. Pain intensity, degree of pain interference with activities of daily living (resulting in disability), and health-related quality of life are among the primary outcomes in studies in patients with LBP. Over and above that, age, psychological factors, for instance, emotional distress, and dysfunctional pain coping mechanisms assume an essential role in the development and/or persistence of nonspecific chronic low back pain (CLBP). Various clinicians use dry needling to treat myofascial pain and motor dysfunction. Disabling low back pain is partly iatrogenic in meagre-income countries, and for indigenous and assimilated populations in opulence-income countries, exposure to health care can intermittently have harmful consequences. Over-medicalization disproportionately masquerades the wealthy minority; however, it also threatens to alleviate the approachability of high-value healthcare facilities for the poor majority and further widen health and social disparities. Protection of the public from unproven or harmful approaches to managing LBP stipulates supervision and healthcare leaders to tackle entrenched and counterproductive reimbursement strategies, vested interests, and financial and professional incentives. As with drugs, which are subject to strict regulation in many countries, new diagnostic tests and non-drug treatments should be available only in trials until their efficacy, safety, and cost-effectiveness are established by robust research evidence.

Dry needling is a therapeutic procedure comprising of the insertion of a thin filiform needle directly into myofascial trigger points, although clinicians often view the elicitation of local twitch response during dry needling as a primary goal and indicator of successful treatment, there is scarce evidence supporting this assertion. Applying Dry needling along the combination of physiotherapy to treat low back pain has dramatically advanced the understanding of the prognostic significance of both physical & psychosocial factors in individual patients. An active ongoing monitoring system is crucial to assess the effects of new strategies on outcomes such as disability, ability to work, and social participation. Dry needling (DN) is a minimally invasive physiotherapy technique used to treat neuromusculoskeletal disorders. Its goal is to restore the physiological state of the tissue, reduce pain levels, and increase mobility by applying mechanical stimuli caused by the insertion of acupuncture needles. These techniques are typical of physiotherapy, in which the physical agents pass through the patient’s skin.

In Bangladesh, there is paucity enough relatable research regarding clinical trials. The present study arises from the need to deepen knowledge about the treatment of LBP through physiotherapy techniques which clinical trial is scantly in our country’s field. The goal was to assess the effectiveness of invasive procedures ‘specifically DN’ in pain levels and their relationship with other measurement variables to establish action guidelines for the physiotherapeutic approach to LBP. Therefore, the main objective is to do a systematic evaluation of the effectiveness of dry needling in the treatment of chronic low back pain.

 
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