| CTRI Number |
CTRI/2026/03/105547 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing two types of exercise using a medicine ball and a Swiss ball to reduce pain and improve range of motion and functional disability in people with long-term low back pain. |
|
Scientific Title of Study
|
Effects of lumbar stabilization exercises using swiss ball and medicine ball on pain, range of motion, disability among patients with chronic low back pain: a comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| rambophysioreddifmail.com |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TARANPREET KAUR |
| Designation |
PG student |
| Affiliation |
DAV institute of physiotherapy and rehabilitation |
| Address |
DAV institute of physiotherapy and rehabilitation Mahatma Hans Raj Marg, Opposite Burlton Park, Gurdev Nagar, Ram Nagar, Jalandhar, Punjab 144008 sports opd
Jalandhar
PUNJAB
144008
India |
| Phone |
8968588568 |
| Fax |
|
| Email |
tanugill788@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ram babu(PT) |
| Designation |
associate professor |
| Affiliation |
DAV institute of physiotherapy and rehabilitation |
| Address |
DAV institute of physiotherapy and rehabilitation Mahatma Hans Raj Marg, Opposite Burlton Park, Gurdev Nagar, Ram Nagar, Jalandhar, Punjab 144008
Jalandhar
PUNJAB
144008
India |
| Phone |
8284886611 |
| Fax |
|
| Email |
rambophysio@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
TARANPREET KAUR |
| Designation |
PG student |
| Affiliation |
DAV institute of physiotherapy and rehabilitation |
| Address |
DAV institute of physiotherapy and rehabilitation Mahatma Hans Raj Marg, Opposite Burlton Park, Gurdev Nagar, Ram Nagar, Jalandhar, Punjab 144008 sports opd
Jalandhar
PUNJAB
144008
India |
| Phone |
8968588568 |
| Fax |
|
| Email |
tanugill788@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| TARANPREET KAUR |
DAV institute of physiotherapy and rehabilitation |
DAV institute of physiotherapy and rehabilitation Mahatma Hans Raj Marg, Opposite Burlton Park, Gurdev Nagar, Ram Nagar, Jalandhar, Punjab 144008 sports opd
Jalandhar
PUNJAB |
08968588568
tanugill788@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COM MITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To compare the effects of lumbar stabilization exercises using swiss ball with chronic low back pain. |
swiss ball exercises, IFT(for 20 minutes), SWD(for 15 minutes)
Treatment is given for 2 weeks, 5 sessions per week. |
| Comparator Agent |
To compare the effects of lumbar stabilization exercises using medicine ball with chronic low back pain. |
medicine ball, IFT( for20 minutes), SWD(for 20minutes)
Treatment is given for 2 weeks, 5 session per week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects complain of having low back pain for more than 3 months or more.
2.Both males and females will be included.
3.Subjects between 18 to 50 years of age.
4.Subjects having moderate pain intensity (between 45-75mm on VAS)
5.Subjects who will give an informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Subjects having radiating pain in lower extremities.
2.Subjects having neurological disorders (weakness in lower limb, diminished reflexes of upper or lower limb, impaired sensation over low back and lower limb, paraparesis, hemiplegia, parkinsonism and multiple sclerosis).
• Subjects prediagnosed with any kind of malignancy
3.Subjects who underwent any recent surgery related to spine, upper limb, lower limb or abdomen.
4.Subjects with any vascular pathology.(DVT, Varicose vein, homan’s sign)
5.Subjects with any pain in upper extremity on weight bearing.
6.Pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effects of SWD and IFT on pain, disability and range of motion among patients with chronic low back pain in control group.
To study the effects of lumbar stabilization exercises using medicine ball on
pain, range of motion and disability among patients with chronic low back pain.
To study the effects of lumbar stabilization exercises using swiss ball on pain, range of motion and disability among patients with chronic low back pain.
|
1st day, 5th day and 10th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effects of lumbar stabilization exercises using medicine ball & swiss ball on pain, range of motion & disability among patients with chronic low back pain.
functional mobility,lumbar range of motion, muscle spasm, quality of life
|
1st day, 5th day & 10th day |
|
|
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)
|
01/05/2026 |
| 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="6"
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
|
A minimum of 45 subjects both males and females aged between 18-50 with chronic low back pain will be selected as per inclusion and exclusion criteria. Subjects will be conveniently divided into 3 groups with 15 subjects in each group. Group A will serve as control group and will be given Interferential Therapy (IFT) and Short-Wave Diathermy (SWD) and this treatment will serve as ‘baseline treatment’. Group B will be given Lumbar Stabilization Exercises using Medicine Ball along with baseline treatment and Group C will be given Lumbar Stabilization Exercises using Swiss Ball along with baseline treatment. Treatment will be given for two weeks 5 sessions per week in all groups. Pain will be assessed with Visual Analog Scale (VAS), disability with Modified Oswestry Disability Index (ODI) and Range of motion with Modified-Modified Schober’s Index, on pre-intervention 1st day, post intervention 5th day and post intervention on 10th day. |