The aim of this study is to compare the effect of spinal manipulation therapy, general exercise therapy and motor control exercises in chronic low back pain patients.
Design
Randomize control clinical trial, three parallel groups with single blinded study
Settings and conduct
Sample size is 36. Randomized clinical trial will be conducted and the data will be collected from Kannan physiotherapy and spinal clinic,Lahore.
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA:Non-specific low back pain for at least 3 months,Age between 18 and 35 years
EXCLUSION CRITERIA:Neurological signs, Specific spinal pathology ,Back surgery. Serious low back pathology
Intervention groups
Three interventional groups named as general exercises, motor control exercises and spinal manipulation therapy are formed. First two groups participants will attend eight sessions of one hour, twice a week, for four weeks.The first group class will be modeled on the ‘Back to Fitness’ program described by(Klaber Moffett and Frost, 2000). The classes will start with Warm-up and Stretching. After about seven to ten minutes, stretching exercises are started then Warm-down and Relaxation. Secong group will be teached how to contract the transversus abdominis and multifidus muscles in isolation from the more superficial trunk muscles, but in conjunction with the pelvic floor muscles. Spinal manipulative group participants will be given joint mobilization or manipulation techniques applying to the lumber spine (Maitland et al.,2001).
Participants in this group will not get exercises or a home exercise program, and they will get advice to avoid pain-aggravating activities. Manipulative therapy will discontinue if the participant completely recover before the 8 sessions are complete.
Main outcome variables
Two primary outcomes.
• Function
•Pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200511047391N1
Registration date:2020-06-27, 1399/04/07
Registration timing:retrospective
Last update:2020-06-27, 1399/04/07
Update count:0
Registration date
2020-06-27, 1399/04/07
Registrant information
Name
Ammara Khalid
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 44 2662064
Email address
ammarakhalid33@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-26, 1398/09/05
Expected recruitment end date
2020-05-30, 1399/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of general exercise, motor control exercise and spinal manipulative therapy for chronic low back pain: A randomized trial.
Public title
Effect of general exercise, motor control exercise and spinal manipulative therapy in treatment of low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
o Non-specific low back pain for at least 3 months
o Age between 18 and 80 years
o Written informed voluntary consent
Exclusion criteria:
o Neurological signs
o Specific spinal pathology (e.g. malignancy, or inflammatory joint or bone disease)
o Back surgery.
o Serious low back pathology
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Randomisation is done through simple random sampling. Concealment of allocation through sealed envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
An accessor will be hired who will access the initials and outcome of the patients at the end of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Riphah College of Rehabilitation and Allied health science
Street address
28-M Quaid-e-Azam Industrial Estate Kot Lakhpat, Lahore,
City
Lahore
Postal code
54770
Approval date
2019-10-08, 1398/07/16
Ethics committee reference number
REC/RCRS/20/1014
Health conditions studied
1
Description of health condition studied
Chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Function
Timepoint
Once before intervention and one after the discharge that is 4 weeks.
Method of measurement
Patient-Specific Functional Scale
2
Description
Pain
Timepoint
Once before intervention and one after the discharge that is 4 weeks.
Method of measurement
Numerical pain rating scale
Secondary outcomes
1
Description
Secondary outcome is Disability measured by:• Oswestry Disability Index.
Timepoint
Once at the start of the study and once at the end of the study that is after 4 weeks.
Method of measurement
Disability measured by Oswestry Disability Index.
Intervention groups
1
Description
General exercise group determine:• How physically active the participant is• How troublesome the back problem is• The ability of the participant to perform the exercises. Participant will attend eight sessions of one hour, twice a week, for four weeks. The exercises will be performed under the supervision of a physical therapist in classes of up to 12 people. The intensity of the exercises will be progressing over the 8 treatments with participants being encouraged to improve their own performance rather than competing with other members of the class. The main aims of the program will be to improve physical function and confidence in using the spine, and to teach participants how to cope with their back problems.The exercises aim to:• Strengthen the main muscle groups of the body, including the abdominal and trunk muscles,• Stretch the main muscle groups • Increase cardiovascular fitness with low-impact aerobic exercises. The classes will start with Warm-up and Stretching: After about seven to ten minutes, stretching exercises are started. Warm-down and Relaxation:These are similar to the warm-up exercises, but should allow the body gradually to slow down and cool down.After a warm-down session, there will be a short relaxation session and then, at the end of the class, a brief educational message will be provided as a ‘‘tip of the day’’.
Category
Rehabilitation
2
Description
Participants allocating to the motor control exercise group will be prescribing exercises aiming to:• Improve function of specific trunk muscles thought to control inter-segmental movement of the spine, including transversus abdominis, multifidus, the diaphragm and pelvic floor muscles.Initially participants are going to teach how to contract the transversus abdominis and multifidus muscles in isolation from the more superficial trunk muscles, but in conjunction with the pelvic floor muscles. • Proper engagement of your TVA and Pelvic Floor feels like a gentle upward and inward pulling. Inhale to prepare. Exhale as you gently pull upward on pelvic floor and inward with tummy to spine. Inhale to release the muscles. Multifidus Activation: The difficulty of the tasks will be progressing by incorporating more functional positions and training the coordination of all trunk muscles during functional.When treating participants in both exercise groups, physical therapists will apply principles of cognitive-behavioural therapy.Participants in both exercise groups will be encouraged to exercise at home at least once a day and to finish all 8 training sessions regardless of the extent of recovery.
Category
Rehabilitation
3
Description
Participants allocating to the spinal manipulative therapy group will get treated with:• Joint mobilization or manipulation techniques applying to the lumber spine. •Grade I-IV joint mobilization may be useful as a pre-test for the appropriateness of manipulation, as a pre-treatment for manipulation, or as a substitute for manipulation in patients where manipulation might be contraindicated. Grade V mobilization should be construed as joint manipulation or adjusting. The particular dose and techniques will be at the discretion of the treating physical therapist, based on:• Each participant’s physical examination findings. Participants in this group will not get exercises or a home exercise program, and they will get advice to avoid pain-aggravating activities. Manipulative therapy will discontinue if the participant completely recover before the 8 sessions are complete, as is standard clinical practice.The physical therapist will qualify to apply all three interventions. Participants in all groups are going to ask not to seek other treatments and where possible not to change current medications for the 4 week trial period.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kannan physiotherapy and spinal clinic
Full name of responsible person
Dr. Naveed Anwar
Street address
Shahrah Aiwan-e-Sanat-o-Tijarat Opposite Governor House Main Gate, , Lahore, Pakistan-00054
City
Lahore
Postal code
00054
Phone
+92 42 36281882
Email
naveed.anwar982@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Ammara Khalid
Street address
house num 10 street num 2 chaudhary colony faisalabad road okara
City
okara
Postal code
56300
Phone
+92 44 2662164
Email
ammarakhalid33@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
self funded
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Ammara Khalid
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Orthopedics
Street address
St.no 2, house no. 10 Chaudhary colony Faisalabad road okara,pakistan
City
Okara
Province
Punjab
Postal code
56300
Phone
+92 44 2662064
Fax
Email
ammarakhalid33@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Ammara Khalid
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Orthopedics
Street address
St.no 2, house no. 10 Chaudhary colony Faisalabad road okara,pakistan
City
Okara
Province
Punjab
Postal code
56300
Phone
+92 44 2662064
Fax
Email
ammarakhalid33@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Ammara Khalid
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Orthopedics
Street address
St.no 2, house no. 10 Chaudhary colony Faisalabad road okara,pakistan
City
Okara
Province
Punjab
Postal code
56300
Phone
+92 44 2662064
Fax
Email
ammarakhalid33@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all collected deidentified IPD
When the data will become available and for how long
most probably starting 6 months after publication
To whom data/document is available
For researchers
Under which criteria data/document could be used
for research purposes
From where data/document is obtainable
Through email
What processes are involved for a request to access data/document