| CTRI Number |
CTRI/2024/12/078485 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Check the Impact of Laser
Therapy and Shockwave Therapy on Low Back Pain in Sweepers |
|
Scientific Title of Study
|
Comparison of Laser Therapy and Extracorporeal Shockwave Therapy among Sweepers with Sacroilliac Joint Dysfunction on Range of Motion Pain and Quality of Life-A Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rabeena PT |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B319 Galgotias University Department of Physiotherapy School of Allied and Health Sciences Sector 17A Opposite Buddha International Circuit Gautam Buddha Nagar Greater Noida India 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9717785790 |
| Fax |
|
| Email |
rabeena@galgotiasuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rohit Yadav |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Room No E004 Galgotias University Department of Physiotherapy School of Allied and Health Sciences Sector 17A Opposite Buddha International Circuit Gautam Buddha Nagar Greater Noida India 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8920038273 |
| Fax |
|
| Email |
yadavrohit9289@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRabeena PT |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Room No E004 Galgotias University Department of Physiotherapy School of Allied and Health Sciences Sector 17A Opposite Buddha International Circuit Gautam Buddha Nagar Greater Noida India 203201
Room No B319 Galgotias University Department of Physiotherapy School of Allied and Health Sciences Sector 17A Opposite Buddha International Circuit Gautam Buddha Nagar Greater Noida India 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9717785790 |
| Fax |
|
| Email |
rabeena@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell Galgotias University Department of Physiotherapy School of Allied and Health Sciences Sector 17A Opposite Buddha International Circuit Gautam Buddha Nagar Greater Noida Uttar Pradesh India 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University Greater Noida |
| Address |
Room No C113 Galgotias University Department of Physiotherapy School of Allied and Health Sciences Sector 17A Opposite Buddha International Circuit Gautam Buddha Nagar Greater Noida India 203201 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rabeena |
GALGOTIAS UNIVERSITY |
Room No E004 Galgotias University Department of Physiotherapy School of Allied and Health Sciences Sector 17A Opposite Buddha International Circuit Gautam Buddha Nagar Greater Noida India 203201
Gautam Buddha Nagar
UTTAR PRADESH |
9717785790
rabeena@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee, Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Evidence based practice |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Extracorporeal Shock Wave Therapy |
The control group will receive hot pack for 10 min. Extracorporeal Shock Wave the application was conducted by a direct contact method applied at the sacroiliac joint and the quadratus lumborum muscle(the site of pain). To reduce the tissue resistance and improve the energy propagation, a lubricant was used. All patients in this group received 2 sessions every week for 8 weeks. |
| Intervention |
Laser Therapy |
Participants in the intervention group will receive hot pack for 10 minutes. Administer 16 sessions over 8 weeks(2 session per week). Each session will last 15-20 minutes, focusing on the sacroiliac joint and surrounding arear. Follow manufacturer guidelines for laser application parameters |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Individual with persistent lower back pain(more than 3 months).
2.Individual must be an actively sweepers.
3. Both male and female patients will be included in the study. |
|
| ExclusionCriteria |
| Details |
1.Patient with any surgery of sacrum fracture.
2..Participants with cognitive impairments or psychiatric conditions affecting their ability to provide informed consent.
3.Individual not willing to participate.
4.Presence of infections or significance skin condition in the area to be treated with laser therapy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1Range of Motion
2 QOL |
Baseline 4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease pain and improve quality of life |
Baseline 4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/01/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is a Pilot and an Interventional study. The SI joint, connecting the spine and pelvis, is responsible for stability and distributing trunk stress to the lower limbs. Sacroiliac joint dysfunction (SIJD) is a common cause of lower back pain, affecting 15-40% of individuals. Low-level laser therapy (LLL) is a non-invasive, safe treatment option for musculoskeletal disorders, offering simplicity, cost-effectiveness, and convenience. ESWT, a novel, non-invasive, secure, and reasonably priced approach, improves bone, tendon, and soft tissue regeneration and repair. This intervention study investigates the effect of two electrotherapy modalities laser therapy and extracorporeal shockwave therapy on sacroiliac joint pain checking the range of motion, pain, and overall quality of life among sweepers aged 20-50 years old. This study assesses the prevalence of SI Joint pain in this population. It explores its association with the pain (visual analogue) scale and overall quality of life (via the SF 36 Health Survey). Participants with any open wound, or recent spinal surgeries are excluded. participants will be randomly assigned to either experimental group. Participants should be divided into two groups. 15-15 subjects will be placed in each group.
Laser Therapy Group: Equipment: Use a low-level laser therapy (LLLT) device, adhering to established protocols. Treatment Protocol: Administer 6 sessions over 2 weeks (3 sessions per week).Each session will last 15–20 minutes, focusing on the sacroiliac joint and surrounding areas
Shockwave Therapy Group: Equipment: Use an ESWT device, adhering to established protocols. Treatment Protocol: Administer 6 sessions over 2 weeks (3 sessions per week). Each session will last 10-15 minutes, focusing on the sacroiliac joint and surrounding areas.
The finding of the RCT will be improving the Range of Motion, Quality of Life, or alleviating pain among patients with persistent SI Joint pain. By incorporating patients’ perceptions of changes, the study provided a holistic understanding of the intervention’s impact on individuals’ subjective experiences and overall well-being. |