| CTRI Number |
CTRI/2019/06/019559 [Registered on: 06/06/2019] Trial Registered Retrospectively |
| Last Modified On: |
04/06/2019 |
| 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
|
treatment with pilates exercises for low back pain due to disc buldge |
|
Scientific Title of Study
|
Comparison of the effect of Pilates exercises and Back rehabilitation protocol on pain, core strength and functional status in patients with lumbar disc herniation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Gulunjkar |
| Designation |
PG student |
| Affiliation |
sancheti institute college of physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy, Thube park 16,
Shivaji nagar, Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
7507928868 |
| Fax |
|
| Email |
poojagulunjkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravinder Kaur Mahapatra |
| Designation |
Associate Professor |
| Affiliation |
MAEERs PHYSIOTHERAPY COLEGE |
| Address |
MAEERs Physiotherapy College, Near station road, Talegaon Dabhade
Pune
MAHARASHTRA
410507
India |
| Phone |
9823236752 |
| Fax |
|
| Email |
drravinder82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Gulunjkar |
| Designation |
PG student |
| Affiliation |
sancheti institute college of physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy, Thube Park 16, Shivaji Nagar, Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
7507928868 |
| Fax |
|
| Email |
poojagulunjkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute College Of Physohtherapy, Thube park 16, Shivaji Nagar, Pune |
|
|
Primary Sponsor
|
| Name |
sancheti institute |
| Address |
sancheti institute college of physiotherapy, thube park 16, shivajinagar, pune |
| 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 Pooja Gulunjkar |
Sancheti Institute of Orthopedics and Rehabilitation center |
SIOR building, Physiotherapy Out patient department, basement, room 10
Pune
MAHARASHTRA |
7507928868
poojagulunjkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SIOR institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, (2) ICD-10 Condition: M488||Other specified spondylopathies, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional back rehabilitation protocol |
Exercises - core activation,pelvic tilt, core with slr, bridging, prone on elbow, alternate leg and hand extension, hip extension in prone
exercises were given 5 days in a week for 4 week. (2 week supervised followed by 2 week home exercise program) |
| Intervention |
pilates exercise |
Exercises - hundreds, shoulder bridge, single leg circles, double arm stretch, side kick,single leg kick, swimming exercise
exercises were given 5 days in a week foe total 4 weeks (2 weeks supervised followed by 2 weeks home exercise program) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of lumbar disc herniation (Grade I and II) Christian W and Boos N 2004, confirmed on MRI scan of both gender between the age group of 20-55 years; symptomatically in sub-acute or chronic stage (4 weeks – 6 months)of low back pain with or without lower limb radiation and pain intensity level on visual analogue scale of 3-7/10 |
|
| ExclusionCriteria |
| Details |
Patients with Sequestered disc, Spinal cord injury-fracture or instability; Infection, Space occupying lesions (SOL) or Systemic diseases like Rheumatoid arthritis, Progressive neurological disorder; those having a history of spinal surgery or pain block were excluded from the study. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
pain(VAS)
core strength(pressure biofeedback unit)
|
Day 1 and after 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| functional disability (ODI) |
day 1 and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/05/2015 |
| Date of Study Completion (India) |
21/07/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim
- To compare the effectiveness of Pilates exercises and Back rehabilitation
protocol on pain, core strength and functional status in low back pain patients
with lumbar disc herniation.
Hypothesis - Pilates exercises protocol is more effective
than conventional Back rehabilitation protocol for reducing pain, improving
functional status and increasing core muscle strength in low back pain patients
with lumbar disc herniation.
Methodology
– Thirty-nine subjects were included in the study and allocated in two groups
Pilates and Back rehabilitation group. They were given supervised intervention
for 2 weeks followed by 2 weeks of home exercise program. Hot fomentation and
ergonomic advice were given to patients in both the groups. Outcome measures
assessed were VAS, Pressure biofeedback unit and Oswestry disability index to
assess pain, core strength, and disability respectively pre-treatment at week 0
and post 4-week intervention.
Results
– Statistical analysis was done using SPSS version 24. There was a significant
difference on an intra-group analysis in outcome measures in Pilates and Back
rehabilitation group, however, a non-significant difference existed on an
inter-group comparison between the two groups (p-value ≥ 0.05).
Conclusion
– Both the intervention techniques that is Pilates exercises and Back
rehabilitation protocol were equally effective in reducing pain, increasing
core strength and reducing disability over a period of 4 weeks in low back pain
patients with lumbar disc herniation. Key words- Pilates
exercises, Back rehabilitation, low back pain, lumbar disc herniation
|