| CTRI Number |
CTRI/2019/05/018916 [Registered on: 03/05/2019] Trial Registered Prospectively |
| Last Modified On: |
31/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
effect of core exercises with breathing exercoses on chronic low back pain |
|
Scientific Title of Study
|
Effect of incorporating diaphragmatic breathing exercises with core stabilization exercises on pain, disability and sleep in chronic low back pain.
|
| Trial Acronym |
DBECSPDSLBP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Zubia Veqar |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre For Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia,Maulana Md Ali Jauhar Marg, Okhla, NEW DELHI, DELHI-110025
South
DELHI
110025
India |
| Phone |
|
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zubia Veqar |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre For Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia,Maulana Md Ali Jauhar Marg, Okhla, NEW DELHI, DELHI-110025
DELHI
110025
India |
| Phone |
|
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sana Masroor |
| Designation |
Student |
| Affiliation |
Center for physiotherapy and rehabilitation science |
| Address |
Centre For Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia,Maulana Md Ali Jauhar Marg, Okhla, NEW DELHI, DELHI-110025
South
DELHI
110025
India |
| Phone |
|
| Fax |
|
| Email |
sanamasroor786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, okhla, New Delhi, India |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Centre For Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia,Maulana Md Ali Jauhar Marg, Okhla, NEW DELHI, DELHI-110025 |
| Type of Sponsor |
Other [central university] |
|
|
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 Zubia Veqar |
Jamia Millia Islamia |
Room no 204, Centre For Physiotherapy and Rehabilitation Sciences,Jamia Millia Islamia,Maulana Md Ali Jauhar Marg, Okhla, NEW DELHI, DELHI-110025
South
DELHI |
9958993486
veqar.zubia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, JAMIA MILLIA ISLAMIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M799||Soft tissue disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
core stabilization exercises only |
Core stabilization exercise for 4 weeks:
Core stabilization exercise is performed 3 days a week for 4 weeks. A session involve 5 min. warm up on stationary cycling, 20 min core stabilization exercise involving 10 second hold, 10 repetition, 3-4 sec rest between each contraction and doing 3 sets. The session winds up by 5 min. of cool down on stationary cycling.
The exercise for core stabilization is incorporate into 6 stages;
Stage1: facilitation of lumbar multifidus and transverse abdominus;
• Four point kneeling and patients is doing hollowing of abdominals
• Either in Standing or sitting subject lift their contralateral arm
• Pressure bio-feedback unit shall use to activate the muscles
Stage 2: Co- contraction of transverse abdominus and lumbar multifidus
Stage 3:
• Isolated arm movement of surrounding body area while maintaining lumbopelvic neutral
• Subject sits on stable surface with feet on ground and subject move the part while maintaining lumbopelvic in neutral.
Stage 4:
• Maintain the co- contraction while moving the one body part
Stage 5:
• Control of lumbopelvic region during movement
• Sitting on unstable surface, start from balancing to movement of lumbar spine, hip and then lifting the leg and maintaining the position
Stage 6: Lumbar stability with heavy load dynamic task:
• Bridging exercise on stable surface progress to single leg bridge then further progress to bridge on ball followed by single leg on ball.
• Four point kneeling progress from extension of one leg to alternate arm leg lift.
• Single leg and arm extension in prone position
• Trunk flexion with rotation
|
| Intervention |
core stabilization exercises with breathing exercises |
Diaphragmatic breathing exercise with core stabilization exercise for 4 weeks:
Core stabilization exercise is performed 3 days a week for 4 weeks. A session involve 5 min. warm up on stationary cycling, 20 min core stabilization exercise involving 10 second hold, 10 repetition, 3-4 sec rest between each contraction and doing 3 sets. The session winds up by 5 min. of cool down on stationary cycling.
The exercise for core stabilization is incorporate into 6 stages;
Stage1: facilitation of lumbar multifidus and transverse abdominus;
• Four point kneeling and patients is doing hollowing of abdominals
• Either in Standing or sitting subject lift their contralateral arm
• Pressure bio-feedback unit shall use to activate the muscles
Stage 2: Co- contraction of transverse abdominus and lumbar multifidus
Stage 3:
• Isolated arm movement of surrounding body area while maintaining lumbopelvic neutral
• Subject sits on stable surface with feet on ground and subject move the part while maintaining lumbopelvic in neutral.
Stage 4:
• Maintain the co- contraction while moving the one body part
Stage 5:
• Control of lumbopelvic region during movement
• Sitting on unstable surface, start from balancing to movement of lumbar spine, hip and then lifting the leg and maintaining the position
Stage 6: Lumbar stability with heavy load dynamic task:
• Bridging exercise on stable surface progress to single leg bridge then further progress to bridge on ball followed by single leg on ball.
• Four point kneeling progress from extension of one leg to alternate arm leg lift.
• Single leg and arm extension in prone position
• Trunk flexion with rotation
Diaphragmatic breathing exercise is incorporate in subjects for 3 days a week for 4 weeks, 6 repetitions of 2 sets. Diaphragmatic breathing pattern is achieved by maintaining normal breathing pattern for 2-3 sec during inspiration and 8-10 sec during expiration and inducing the activation of pelvic floor muscle and deep abdominal muscle. The inspiration is quite and normal through the nose. Exhalation is through mouth and while exhaling subject lift the pelvic floor up. The lift should be maintained by subjects. The breathing exercise sequence is as follows:
• In supine lying: inhalation is incorporated by upward stretch of arm and maintaining the spine neutral and arm stretch while lifting the pelvis up during exhalation.
• In erect sitting: lower limb is straight and arms extended in front of the chest. The spine elongating more vertically and lifting the pelvis up during exhalation phase of breathing.
• In kneeling, sits on heel: exhalation is accompanied with lateral bending of trunk while lifting the pelvis up.
• In kneeling: subject one arm is bent in front of the eyes and other is resting on the floor. Trunk is rotated to the right while inhalation phase of breathing. Keeping the body rotated and stretched while lifting the pelvic up during exhalation
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
1. Low back pain more than 3 month
2. Patients willing and able to participate in an exercise program safely and without cognitive impairments that would limit their participation.
3. Age: 20-60 years
4. Pain: 2 to 7 on NPRS
5. Gender: male and female
6. Working knowledge of English
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
1. Any other limiting condition which would make diaphragmatic breathing contraindicating
2. Any other neurological disorder, underlying respiratory pathology
3. History of surgery in past year
4. History of injury in preceding 3 months
5. Spinal surgery
6. Osteoporosis
7. Subjects on sleep medication which affect sleep directly
8. Pregnancy
9. Diagnosed cardiovascular disease
10. Orthopedics problem limiting physical activity
11. Those already doing intensive physical activity >2h/week
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain, disability and sleep |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Electromyography, chest expansionand fear avoidance belief questionnaire |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/05/2019 |
| Date of Study Completion (India) |
18/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objective of the study: To
compare the effect of combining diaphragmatic breathing with core stabilization
exercise in patients with chronic low back in pain, disability, and sleep. Significance of the study: CLBP
is a common problem in adults. Current recommendation for treating the patient
with CLBP is core stabilization exercises. The core stabilization exercises
were found effective in many studies in reducing pain and disability. Currently
there is no evidence of improving the symptoms by incorporating the
diaphragmatic breathing exercise with core stabilization exercise which is one
of the important core muscle. The pain and disability was found improved with
core stabilization exercise but it is not reported that the sleep quality were
improved or not. Therefore, this study evaluates the effect of core
stabilization exercises with diaphragmatic breathing exercise on sleep quality,
pain and disability on individual with CLBP. Clinically the result of this
study one can apply to improve the patient’s pain disability and sleep. Method: Total of 22 sample of (1=experimental
group, 11=control group) will be taken from Jamia Millia Islamia, New Delhi,
India based on the inclusion exclusion criteria. Research design: Two
group comparative pretest-posttest design, with random allocation into groups. Procedure: CLBP
subjects will be recruited based upon the inclusion; exclusion criteria and subjects
will be informed about the study. All the subjects will be explained about the
purpose and possible risks of the study. They will be requested to sign the
informed consent which will explain about their rights as research subjects. Pre-test
will be done on the transverse abdominus activation, FABQ, NPRS, ODI, chest
expansion and PSQI parameters. The subjects will be randomly allocated into
experimental and control group by chit method. Experimental group shall receive
core training exercise with diaphragmatic breathing exercise and control group
only incorporate with core training. After four weeks of intervention, both the
group will reassess on the transverse abdominus activation, FABQ, NPRS, ODI,
chest expansion and PSQI parameters.
|