| CTRI Number |
CTRI/2025/10/096143 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare dry needling and kinesio taping for reducing back pain in people with lumbar lordosis |
|
Scientific Title of Study
|
A comparative study to rule out the effectiveness of Dry needling along with core and back strengthening exercises versus kinesio taping along with core and back strengthening exercises for Lordotic patients with paraspinal muscle spasm of spine- A randomized control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakkam Heleena |
| Designation |
student |
| Affiliation |
lovely professional university |
| Address |
Department Of Physiotherapy
room number 105
School of Allied Medical Sciences
Lovely Professional University
kapurthala Punjab
Department Of Physiotherapy
room number 105
School of Allied Medical Sciences
Lovely Professional University
kapurthala Punjab
Kapurthala PUNJAB 144411 India |
| Phone |
8919243439 |
| Fax |
8919243439 |
| Email |
lakkamheleena@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Reema rasotra |
| Designation |
Assistant professor |
| Affiliation |
lovely professional university |
| Address |
Department Of Physiotherapy Block 3 Room no 105 Lovely School of Allied Medical Sciences
Lovely Professional University
kapurthala Punjab
Department Of Physiotherap y Block 3 Room no 105 lovely School of Allied Medical Sciences
Lovely Professional University
kapurthala Punjab
Kapurthala PUNJAB 144411 India |
| Phone |
9888706015 |
| Fax |
9888706015 |
| Email |
rasotra1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Lakkam Heleena |
| Designation |
student |
| Affiliation |
lovely professional university |
| Address |
Department Of Physiotherapy Block 3 Room no 105 Lovely School of Allied Medical Sciences
Lovely Professional University
kapurthala Punjab
Department Of Physiotherapy Block 3 Room no 105 Lovely School of Allied Medical Sciences
Lovely Professional University
kapurthala Punjab
Kapurthala PUNJAB 144411 India |
| Phone |
8919243439 |
| Fax |
8919243439 |
| Email |
lakkamheleena@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lakkam Heleena |
| Address |
Lakkam Heleena
MPT Orthopedics
Registration number 12419304
Lovely School of Allied Medical Science
Department of Physiotherapy
Hospital
room number 103
Lovely professional university
Contact 8919243439
|
| Type of Sponsor |
Other [self] |
|
|
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 Suresh Mani |
lovely professional university |
lovely school of allied medical sciences
block 3 room number 105
Lpu
Kapurthala
Punjab Kapurthala PUNJAB |
9878331006
suresh.22315@lpu.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Lovely Professional University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M438||Other specified deforming dorsopathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
core and back strengthening exercises |
Patients will undergo a supervised exercise program focused on core stability and back strengthening exercises conducted 4 times a week for one month totaling 16 sessions The following exercises will be included
Planks
Bridges
Back Extensions
Side Planks
|
| Intervention |
Dry Needling with Core and Back Strengthening Exercises |
Dry Needling to lumbar para spinal muscles twice weekly for 4 weeks 8 sessions by a trained physiotherapist using sterile filiform needles along with supervised core and back strengthening exercises 4 times per week for 4 weeks 16 sessions |
| Intervention |
Kinesio taping with Core and Back Strengthening Exercises |
Kinesio taping applied to lumbar para spinal muscles every 3 to 4 days for 4 weeks 16 sessions by a certified physiotherapist using facilitation and inhibition techniques along with supervised core and back strengthening exercises 4 times per week for 4 weeks 16 sessions |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with lumbar lordosis
age between 20 to 40 years
back pain persisting for more than 2 months
willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
History of spinal surgeries
other spinal cord conditions
pregnant women
infections or inflammations in the spinal region
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale NPRS for assessing pain intensity
Inclinometer to assess lumbar range of motion
Patient self report questionnaire to assess daily activity improvement
|
outcomes will be assessed at baseline
2nd week and
4th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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)
|
01/11/2025 |
| 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="6" Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
Modification(s)
|
i will start it from 15th of october The purpose of this study is to compare the effectiveness of dry needling with core and back strengthening exercises, kinesiotaping with core and back strengthening exercises, and core and back strengthening exercises alone in patients with lumbar lordosis who present with paraspinal muscle spasm. Lumbar lordosis is a spinal condition that often results in pain, stiffness, muscle imbalance, and functional limitations. Physiotherapy approaches such as exercise therapy, dry needling, and kinesiotaping are commonly used, but their comparative effectiveness has not been fully established. The study will be a randomized controlled trial with three groups of participants. Group A will receive dry needling along with core and back strengthening exercises, Group B will receive kinesiotaping with core and back strengthening exercises, and Group C will perform core and back strengthening exercises only. Pain will be measured using the Visual Analogue Scale, range of motion will be assessed with an inclinometer, and functional improvements will be recorded based on patient self reports. The study hypothesis is that both dry needling and kinesiotaping combined with core and back strengthening exercises will be more effective than exercises alone in reducing pain, improving mobility, and enhancing functional activities in patients with lumbar lordosis. |