| CTRI Number |
CTRI/2021/03/032102 [Registered on: 18/03/2021] Trial Registered Prospectively |
| Last Modified On: |
17/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
“Effect of structured group exercise program in farmers with non-specific low back pain" |
|
Scientific Title of Study
|
“Effect of structured group exercise program in farmers with non-specific low back pain: An-Experimental study" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshal parmar |
| Designation |
MPT 2nd year (CBR) |
| Affiliation |
Kaher institute of physiotherapy |
| Address |
KLE Academy of Higher Education And Research Institute of Physiotherapy,community physiotherapy and rehabilitation.nehru nagar,belagavi-590010,karnataka. KAHER INSTITUTE OF PHYSIOTHERAPY,KLE,NEHRU NAGAR,BELAGAVI-590010 Belgaum KARNATAKA 590010 India |
| Phone |
9372874294 |
| Fax |
|
| Email |
harshalp036@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prashant naik |
| Designation |
ASSISTANT PROFESSOR DEPARTMENT OF COMMUNITY PHYSIOTHERAPY AND REHABILITATION |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
KLE Academy of Higher Education And Research Institute of Physiotherapy,community physiotherapy and rehabilitation.nehru nagar,belagavi-590010,karnataka.
Belgaum KARNATAKA 590010 India |
| Phone |
9743233382 |
| Fax |
|
| Email |
mptnaik@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Harshal parmar |
| Designation |
MPT 2nd YEAR(CBR) |
| Affiliation |
Kaher institute of physiotherapy |
| Address |
KLE Academy of Higher Education And Research Institute of Physiotherapy,community physiotherapy and rehabilitation.nehru nagar,belagavi-590010,karnataka.
Belgaum KARNATAKA 590010 India |
| Phone |
9372874294 |
| Fax |
|
| Email |
harshalp036@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Reseasrch Nehru Nagar Belagavi |
|
|
Primary Sponsor
|
| Name |
KLE academy of higher education and research |
| Address |
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH.INSTITUTE OF PHYSIOTHERPY JNMC CAMPUS BELAGVI. |
| Type of Sponsor |
Private medical college |
|
|
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 |
| HARSHAL PARMAR |
KAHER institute of physiotherapy |
39-department of community physiotherapy and rehabilitation,kaher institute of physiotherapy,jnmc campus, nehru nagar, belagavi-59-00010, karnataka Belgaum KARNATAKA |
9372874294
harshalp036@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIPT Institutional Research and Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
non specific low back pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
none |
none |
| Intervention |
structured group exercise |
2.Stretching and strengthening exercise.(25 minutes) A.Stretching exercise. Hamstring, TA, piriformis and iliotibial band stretching (10sec hold, 3 repetition). Bending forward and backward in standing with holding position for 10 sec.(10sec hold,3 repetitions). B.Strengthening exercises. Isometric exercises, abdominal tights, partial curls, supine bridging, prone bridging, side line bridging, then progression to Pilates exercises. |
| Intervention |
structured group exercise |
1.Warm up exercises.(5 minutes)
A.Walking forward and backward.
B.Walking sideways.
C. Spot marching.
D. Spot jumping.
|
| Intervention |
structured group exercise |
3. Cool down exercises.(5 minutes). Lying down for 2 minutes followed by Jacobson’s relaxation technique. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Farmers of all gender between age group of 30-60 years.
2.With more than 40% of disability score on modified oswestry low back pain disability questionnaire.
3.Farmers working for more than 7-8 hours per day.
4.Willing to participate in study.
|
|
| ExclusionCriteria |
| Details |
1.Farmers with recent history of any fractures or trauma.
2.With any neurological disorders. Â
3.Any spinal or disc pathology.
4.Lumbar spondylosis, cauda equina syndrome, lumbar canal stenosis.
5.Farmers taking any medications.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.ICF (international classiï¬cation of functioning, disability and health).
2.Pain pressure threshold algometry.
3.Modiï¬ed oswestry low back pain disability questionnaire.
4.Range of motion (Goniometer).
5.Numerical pain rating scale (NPRS).
|
At baseline and after completion of intervention. i.e 6 weeks intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ICF |
PRE and POST intervention
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
20/03/2021 |
| 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="10" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Back disorders are
major cause of sickness,absence and disability in working population and
incidence of low back pain rises sharply in early adulthood. Low back pain has multifactorial etiology and
complex pathogenesis as it is considered to be dynamic and fluctuating condition. For literally hundreds of years
the back has been symbol of strength and focus of stress. In 20th
century back pain was major factor of medical disaster. The back
pain affects up to 85%-90% of the population
at some stage of their lives.
Musculoskeletal
disorders involves wide range of conditions
such as low back pain, osteoarthritis, tennis elbow, golfers elbow, frozen shoulder
but among all this conditions the incidence of low back pain is at peak in
elderly working population. Farming has been consider a high risk
occupation for musculoskeletal disorders.as it is associated with high workload
especially with heavy lifting, bending, twisting, carrying load and heavy
exposure to vibration. The prevalence of low back pain is 60% among
farmers as compared to other musculoskeletal disorders. In recent decade the
principle key elements in treatment of low back pain have largely been pain relieving
techniques such as traction ,relaxation, rest and prevented exercises. supervised group exercise, as an adjunct to usual care, would improve pain, range of motion, level of functioning
and quality of life for individuals with musculoskeletal disorders and that
beneï¬ts would be maintained for
six months to 1 year the intervention. |