The aim of this study is to determine the effects of muscle energy technique and dry needling of active trigger points of quadrats lumborum in low back pain
Design
Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
participants, healthcare providers (Physicians, nurses, etc.) who care for participants during the trial, data collectors, outcome assessors, and with lessor importance Data Safety and Monitoring Board and manuscript writers.
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA:
1. Subjects between 18 to 60 year of age
2. Both gender (Male & Female)
3. Participants have mechanical lower back pain of at least two-months duration, initial MODI Score: 30%-60%
4. Participants have an active trigger point in quadratus lumborum muscle according to Travell and Simons diagnostic critaria
EXCLUSION CRITERIA:
1. Anticoagulation or bleeding disorders.
2. Acute muscle trauma.
3. Local or systemic infections
4. Lumbar disc herniation
5. Spinal deformities
6. Any spinal surgery history
7. Any participant taking anticoagulation medication
Intervention groups
Muscle Energy Technique (Post isometric relaxation)
Dry Neeedling
Muscle Energy Technique and Dry needling comparison study
IRCT registration information
IRCT registration number:IRCT20200221046566N1
Registration date:2020-06-23, 1399/04/03
Registration timing:prospective
Last update:2020-06-23, 1399/04/03
Update count:0
Registration date
2020-06-23, 1399/04/03
Registrant information
Name
Hamna Zahid
Name of organization / entity
Riphah International University Lahore
Country
Pakistan
Phone
+92 42 35956589
Email address
hamnazahid71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-01, 1399/04/11
Expected recruitment end date
2020-07-30, 1399/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Muscle energy technique and Dry needling of active trigger points of Quadratus Lumborum in Lower back pain
Public title
Effects of Muscle energy technique and Dry needling of active trigger points of Quadratus Lumborum in Lower back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants have mechanical lower back pain of at least two-months duration, initial MODI Score: 30%-60%
Participants have an active trigger point in quadratus lumborum muscle according to Travell and Simons diagnostic criteria
Patient is otherwise medically fit to perform physical training
Exclusion criteria:
Anticoagulation or bleeding disorders
Acute muscle trauma
Local or systemic infections
Lumbar disc herniation
Spinal deformities
Any spinal surgery history
Any participant taking anticoagulation medication
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Written informed consent will be taken. After enrollment into study, patient will be allocated either to group A or Group B by lottery method. No. of Chits will be equal to total sample size, odd Numbers will be allocated to Group A and even number will be allocated to Group B. Each patient will be requested to draw a chit from the box and after that patient will be recruited into either Group A or Group B
Blinding (investigator's opinion)
Double blinded
Blinding description
participants, healthcare providers (Physicians, nurses, etc.) Assessor Blind: Data safety will be ensured by assigning Specific Identity numbers and all consent, readings forms will be placed in locker to blind Assessors
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
secretary ethical review committee, Riphah College of Rehabilitation and Allied Health Sciences
Street address
28-M, Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Postal code
54000
Approval date
2020-02-08, 1398/11/19
Ethics committee reference number
REC/RCRS/20/1035
Health conditions studied
1
Description of health condition studied
Low back pain due to trigger points of quadratus lumborum
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
before intervention and 1, 3, 6 weeks after intervention
Method of measurement
Numeric Pain Rating Scale
2
Description
Function
Timepoint
before intervention and 1, 3, 6 weeks after intervention
Method of measurement
Modified Oswestry disability index
Secondary outcomes
1
Description
Trigger Points Sensitivity
Timepoint
before intervention and 1, 3 , 6 weeks after intervention
Method of measurement
Pain Pressure Algometer
Intervention groups
1
Description
Intervention group: Dry Needling of Quadratus Lumborum
Category
Treatment - Other
2
Description
Intervention group: Muscle Energy Technique (METs) of Quadratus Lumborum
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Max Rehab Center, Lahore Pakistan
Full name of responsible person
Muhammad Hashim
Street address
393-D3 wapda Town Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Street address
28-M Quaid-e-Azam Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
20
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Muhammad Salman Bashir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35126110
Email
chistisalman@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Hamna Zahid
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35956589
Email
hamnazahid71@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available