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
|
|
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. |