To determine the comparative effects of Butler neural tissue mobilization and Mulligan Bent leg raise in patients with chronic lumbar radiculopathy.
Design
Parallel groups, single-blind, randomized controlled trial, 62 participants were enrolled
Settings and conduct
OPD physiotherapy department Sheikh Zayed Hospital
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients diagnosed with lumbar radiculopathy with unilateral radiating pain by an orthopedist; Aged 25-50 years; Both Male and Female; Positive neurodynamic test i.e. SLR test and Slump test. Exclusion Criteria: Patients having somatic referred pain; specific diseases of the spine like ankylosing spondylitis, Paget's disease, vertebral collapse, rheumatoid arthritis, and spondylolisthesis; spine Tb, intermittent claudication, diabetic neuropathy; Recent infection;
Mental retardation; hemiparesis.
Intervention groups
Group A: The conventional treatment (hot pack and exercise) includes 10 minutes of hot pack and exercise in addition to Butler neural tissue mobilization. Group B: The conventional treatment (hot pack and exercise) contains 10 minutes of hot pack and exercise in addition to Mulligan bent leg raise, applied for pain, functional activity, and SLR.
Main outcome variables
Pain; ROM (lumber flexion, extension, SLR); Functional Disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200611047734N4
Registration date:2021-10-13, 1400/07/21
Registration timing:retrospective
Last update:2021-10-13, 1400/07/21
Update count:0
Registration date
2021-10-13, 1400/07/21
Registrant information
Name
AYESHA RAZZAQ
Name of organization / entity
King Edward Medical University,Lahore
Country
Pakistan
Phone
+92 61 6521475
Email address
drayesharazzak@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-28, 1399/04/08
Expected recruitment end date
2020-06-29, 1399/04/09
Actual recruitment start date
2020-06-29, 1399/04/09
Actual recruitment end date
2021-03-29, 1400/01/09
Trial completion date
2021-03-29, 1400/01/09
Scientific title
The comparative effects of Butler’s neural tissue mobilization and Mulligan’s bent leg raise in patients with chronic lumbar radiculopathy.
Public title
The comparative effects of Butler’s neural tissue mobilization and Mulligan’s bent leg raise in patients with chronic lumbar radiculopathy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with lumber radiculopathy with unilateral radiating pain by an orthopedics
Age 25-50 years
Both Male and Female
Positive neurodynamic test i.e. SLR test and Slump test
Exclusion criteria:
Patients having Somatic referred pain
Specific diseases of spine like ankylosing spondylitis, paget’s disease, vertebral collapse, rheumatoid arthritis, and spondylolisthesis
Tb spine, intermittent claudication, diabetic neuropathy
Recent infection
Mental retardation
hemiparesis
previous spinal Surgery
Pelvis Fracture
Pregnancy
Red Flags such as trauma, cancer, constitutional symptoms (fever, malaise, weight loss)
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
62
More than 1 sample in each individual
Number of samples in each individual:
2
31 Patients in each group was estimated by using 5% level of significance, 90% power of test
Actual sample size reached:
62
More than 1 sample in each individual
Actual sample size in each individual:
2
31 patients in each group was estimated by using 5% level of significance, 90% power of test
Randomization (investigator's opinion)
Randomized
Randomization description
The lottery method was used for allocating the patient in groups A or B by even and odd numbers. Participants with an even number were placed in group A and with an odd number were placed in group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
It was a single-blinded study in which participant/ patients were kept blind for treatment technique. 2 different technique were provided to patients. and they were blind about that which technique was given to which patients. patients were blind regarding the technique. baseline treatment was the same, but they were not aware of the technique. which techniques they were receiving.
Placebo
Not used
Assignment
Parallel
Other design features
Parallel groups, single blinded, single setting
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board
Street address
Raiwind road
City
Lahore
Postal code
55150
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IRB-UOL-FASH/725-VIII/2020
Health conditions studied
1
Description of health condition studied
Lumber Radiculopathy
ICD-10 code
M47.26
ICD-10 code description
Other spondylosis with radiculopathy, lumbar region
Primary outcomes
1
Description
Pain
Timepoint
pre and post treatment
Method of measurement
Numeric pain rating scale
2
Description
ROM (lumber flexion, extension, SLR)
Timepoint
Pre and post treatment
Method of measurement
Goniometer , Modified Modified Schober’s Test
3
Description
Functional Disability
Timepoint
pre and post treatment
Method of measurement
Oswestry Disability Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Application of conventional therapy and Butler neural tissue mobilization. Butler neural tissue mobilization procedure: Patient was in supine position. Therapist’s position was standing and facing towards the patient position and positioned one hand beneath the ankle to prevent pressure on peripheral nerves and the second hand above the patella. The knee was in extended position, and hip was flexed position in one plane and the leg was take to the point where symptoms was reproduced. Dosage: Slow oscillations or sustained stretch was given by the therapist for 10 s depending on the grade of mobilization after which the leg was returned to a non-painful position. This procedure was repeated three times.
Category
Treatment - Devices
2
Description
Intervention group: Application of conventional therapy and Mulligan bent leg raise. Mulligan bent leg raise Technique. The therapist was stand at limited SLR side of the patient. Patients was flex knee was kept over therapist’s shoulder. Therapist instructed patient to push her away with patient’s leg and then relax. At this point therapist extended the patient’s bent knee up as far as possible in the direction of patient’s ipsilateral shoulder provided there was no pain. If it was painful the direction was altered by taking the leg more medially or laterally. Dosage: Sustained stretch for several seconds was given and leg lowered down to the bed. This technique was repeated 3 times.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
university of Lahore
Full name of responsible person
Sonia Yasmeen
Street address
Raiwind road lahore
City
Lahore
Postal code
55150
Phone
+92 42 32591427
Email
soniayasmeen16@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
university of Lahore, Lahore
Full name of responsible person
Sonia Yasmeen
Street address
Raiwind road lahore
City
Lahore
Postal code
55150
Phone
+92 42 32591427
Email
soniayasmeen16@gmail.com
Grant name
Sonia Yasmeen
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
university of Lahore, Lahore
Proportion provided by this source
20
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
university of Lahore, Lahore
Full name of responsible person
Sonia Yasmeen
Position
physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Raiwind road lahore
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 42 32591427
Email
soniayasmeen16@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
university of Lahore, Lahore
Full name of responsible person
Fareeha Amjad
Position
physiotherapist
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Raiwind road lahore
City
LAHORE
Province
Punjab
Postal code
55150
Phone
+92 42 32591427
Email
fari_fairy22@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mayo hospital lahore
Full name of responsible person
Ayesha Razzaq
Position
physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Nother bypass Multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 61 6800991
Email
drayesharazzak@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The comparative effects of Butler’s neural tissue mobilization and Mulligan’s bent leg raise in patients with chronic lumbar radiculopathy.
When the data will become available and for how long
The study is completed and become available after its publication
To whom data/document is available
Person in academic institute. Patient data will not be shown
Under which criteria data/document could be used
Under the usage with terms in which journal is accessed /processed for publication, it could be used in the request.
From where data/document is obtainable
+923367595206 from the University office and Responsible supervisor and from a journal we will process in future
What processes are involved for a request to access data/document
Can be on call or mail It will be only used in a confidential way for improving research and benefit of humanity