• To compare the effects of Mulligan and Maitland mobilization to decrease pain and improve Range of Motion among patients having Chronic Nonspecific Low Back Pain.
• To find out either Mulligan or Maitland mobilization is effective to eliminate kinesiophobia among patients due to Chronic Non Specific Low Back Pain.
Design
A Single Blinded Randomized Clinical Trial was conducted.
Settings and conduct
Subjects were recruiting from Outdoor Patient Department of;
• District Headquarter Nankana Sahib
• Alkarim Hospital Nankana Sahib
Participants/Inclusion and exclusion criteria
inculsion criteria: • Both gender (Male /Female) with the age 20-40.
• Patient having low back pain with duration of at least 4 months.
• At least moderate pain according to NPRS. • Minimum flexion of lumbar was 37±12° (23).
• Minimum extension of lumbar was 14±4° (23).
• Minimum kinesiophobia was 40±4
exclusion criteria: • Diagnosed with specific disease of LBP (arthritis, SIJ pain, and osteoporosis)
• Recent fracture or history of fracture
• Osteoporosis
• Pregnancy or C-section 6 months ago
• Previous hip or back surgery or fracture less than half year prior
Intervention groups
Group A basically a Mulligan group and Group B was a Maitland group. Group A (Mulligan group), apply Hot Pack first for 10 minutes to warm while the patient lies in a comfortable position. After the warm-up, the patient received a Mulligan mobilization during which the exercisers performed half crunches, knee-to-chest, and hamstring stretches for 15 minutes. And same for Group B (Maitland group), but the difference was to apply Maitland Mobilization.
Main outcome variables
Outcome Measure
Following outcome measures were used to gather data from selected population.
1-Primary Outcome Measure
• Pain intensity = Numeric Pain Rating Scale (NPRS).
• Lumbar Range of Motion = Measuring tape.
2-Secondary Outcome Measure
Kinesiophobia = Tampa Scale.
General information
Reason for update
Acronym
RCT
IRCT registration information
IRCT registration number:IRCT20230530058343N1
Registration date:2023-07-09, 1402/04/18
Registration timing:retrospective
Last update:2023-07-09, 1402/04/18
Update count:0
Registration date
2023-07-09, 1402/04/18
Registrant information
Name
Hafiza mubashra Zahid
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8750971
Email address
2021-ms-pt-074@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-24, 1399/10/04
Expected recruitment end date
2023-06-10, 1402/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of Mulligan and Maitland Mobilization Techniques in chronic Non- Specific Low Back Pain patients.
Public title
Comparing Mulligan and Maitland Mobilization Techniques for Chronic Non-SpecificLow Back Pain Patients
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Both gender (Male /Female) with the age 20-40.
Patient having low back pain with duration of at least 4 months.
At least moderate pain according to NPRS
Minimum flexion of lumbar was 37±12°
Minimum extension of lumbar was 14±4°
Minimum kinesiophobia was 40±4.
Exclusion criteria:
Vascular disease
Diagnosed with systematic disease i.e. TB of spine
Diagnosed with specific disease of LBP (arthritis, SIJ pain, and osteoporosis)
Recent fracture or history of fracture
Osteoporosis
Pregnancy or C-section 6 months ago
Previous hip or back surgery or fracture less than half year prior
Abdominal surgery inside the past 90 days
Treatment of existing back pain by another health care professional within one week
Red flags i.e. tumor, infection, open wound (clinical signs of conceivable serious spinal or foundational messes)
Diagnosed with neurological disease or radiculopathy
Patient who do not receive any PT/ exercise plan from previous 3 months
Refusal for consent.
Age
From 20 years old to 40 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
A Single Blinded Randomized Clinical Trial was conducted for treatment and the unit of randomization through individual. Purposive sampling Technique was used to collect sample and two groups will randomly allocated by lottery method. Total 44 patients was assessed for eligibility criteria, 2 excluded for not meeting the inclusion criteria and 1 refused to participate. then Randamization is done and allocated into two groups Mulligan group and Maitland Group. The Mulligan group has total 21 participant from 21 participant 1 is exclude for not following the treatment session . and the Maitland group has 20 participants. Both groups results has been analyzed through spss version.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants in both Mulligan group and Maitland group are blinded from treatment after giving informed consent.
1-Pain intensity = Numeric Pain Rating Scale (NPRS). 2-Lumbar Range of Motion = Measuring tape 3-
Method of measurement
1-Pain intensity = Numeric Pain Rating Scale (NPRS). On a Numeric Pain Rating Scale (NPRS), patients were approached to check the number somewhere in the range of 0 and 10, 0 and 20 or 0 and 100 that best matches their aggravation power. Zero as a rule addresses 'no aggravation' and as far as possible addresses 'most exceedingly terrible conceivable torment' 2-Lumbar Range of Motion = Measuring tape One of the most common tape measurement procedures used to measure lumbar flexion involves a technique pioneered by Schubert, who described the original two- point method for measuring spinal flexion and later modified it to measure spinal flexion. This makes one mark at the lumbosacral. Junction and the second mark are made 10 cm above the first mark, with the subject in a neutral position with the spine. After the stationary subject bends forward as far as possible, the amount of flexion in the spine is estimated by increasing the distance between the first and second points. Because the tape measure method relies on the stretching or distraction of the skin over the spine, this technique (and modifications of the technique) is sometimes called the skin distraction method. Bone landmarks for tape measure indicate ROM of lumbar extension, midline of spine consistent with PSIS, cm above baseline marker
Secondary outcomes
1
Description
Kinesiophobia
Timepoint
kinesiophobia= Tampa Scale
Method of measurement
The Tampa Scale for Kinesiophobia has a complete score scope of 17-68, with 17 showing no kinesiophobia, 68 demonstrating extreme kinesiophobia, and a score of ±37 showing the presence of kinesiophobia. The contracted variant keeps up with things 1, 2, 3, 5, 6, 7, 10, 11, 13, 15 and 17 from the first TSK- 11 scale and has a score scope of 11-44.
Intervention groups
1
Description
Intervention group: Mulligan Group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
1-Alkarim Hospital Nankana Sahib. 2- District Headquarter Hospital Nankana Sahib
Full name of responsible person
DR- Hafeez-u- Rehman, DR Aijaz
Street address
Near govt. gurunanak girls college Nankana Sahib
City
Nankana Sahib
Postal code
39100
Phone
+92 325 4597992
Fax
+92 41 8868220
Email
hafizamubashrapt@gmail.com
Web page address
https://g.co/kgs/gLB5vY
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Hafiza Mubashra Zahid
Street address
near manawala road, faisalabad
City
faisalabad
Postal code
38000
Phone
+92 41 8750971
Fax
+92 41 8750970
Email
studentaffairsew@tuf.edu.pk
Web page address
https://www.tuf.edu.pk/
Grant name
Hafiza Mubashra Zahid
Grant code / Reference number
03254597992
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
investigator initiated trail
Proportion provided by this source
10
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
hafiza Mubashra Zahid, Maryam Safdar
Position
consultant
Latest degree
Specialist
Other areas of specialty/work
Health Service Management
Street address
near manawala road
City
faisalabad
Province
punjab
Postal code
817185
Phone
+92 41 8750971
Fax
+92 41 8868220
Email
studentaffairsew@tuf.edu.pk
Web page address
https://www.tuf.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Hafiza Mubashra Zahid
Position
consultant
Latest degree
Specialist
Other areas of specialty/work
Health Service Management
Street address
near manawala road
City
Faisalabad
Province
punjab
Postal code
38000
Phone
+92 41 87509715
Fax
+92 41 8750970
Email
studentaffairsew@tuf.edu.pk
Web page address
https://www.tuf.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Hafiza Mubashra Zahid
Position
consultant
Latest degree
Specialist
Other areas of specialty/work
Health Service Management
Street address
near manawala road
City
faisalabad
Province
punjab
Postal code
38000
Phone
+92 41 87509715
Fax
+92 41 8750970
Email
studentaffairsew@tuf.edu.pk
Web page address
https://www.tuf.edu.pk/
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
No - There is not 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
Comparative effects of Mulligan and Maitland Mobilization Techniques in chronic Non- Specific Low Back Pain patients.
When the data will become available and for how long
not sure
To whom data/document is available
The University of Faisalabad
Under which criteria data/document could be used
For Research Purpose
From where data/document is obtainable
website and Email
What processes are involved for a request to access data/document