Comparative effects of mulligan two-leg rotation technique and muscle energy technique on hamstring flexibility, pain and functional disability in patients with chronic non-specific low back pain
To compare the effects of the Mulligan two-leg rotation technique and the Muscle Energy Technique on pain, hamstring flexibility, and functional disability in patients with chronic non-specific low back pain.
Design
The double-blinded, parallel-assigned, bi-center, randomized clinical trial was done on 108 patients with a history of pain for more than 12 weeks. Patients were assigned by using the lottery method of simple random sampling.
Settings and conduct
The study was conducted at the physiotherapy department of Bakhtawar Amin Hospital, Multan.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. Both gender,
2. Age group of 18-35years.
3. Non-specific low back pain for more than 3 months.
4. Patients with hamstrings tightness measured by Active Knee Extension (AKE) test.
Exclusion Criteria:
1. History of fracture or surgery.
2. Low back pain with active systemic or spine pathology.
3. Upper motor neuron or lower motor neuron lesion
4. Pregnancy, psychological risk factor, or subjects apprehensive for the stretching techniques.
Intervention groups
After taking written informed consent, patients meeting the inclusion and exclusion criteria were screened for hamstring tightness by a trained physiotherapist, having greater than 30-degree loss of knee extension.108 patients were randomly allocated into two groups (54 patients each) by a computer-generated random number table. Group A received Mulligan’s two-leg rotation technique with routine physiotherapy and group B received the muscle energy technique with routine physiotherapy. Total 12 sessions were given to both groups, 3 sessions per week. Data was calculated at baseline and after every 6th session.
Main outcome variables
1. Pain measured by Numeric pain rating scale.
2. Hamstring tightness measured by Active knee extension angle.
3. Functional Disability measured by Modified Oswestry Disability Index scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210821052245N1
Registration date:2021-12-07, 1400/09/16
Registration timing:retrospective
Last update:2021-12-07, 1400/09/16
Update count:0
Registration date
2021-12-07, 1400/09/16
Registrant information
Name
Maryam Razzaq
Name of organization / entity
Bakhtawar Amin Medical and Dental college
Country
Pakistan
Phone
+92 61 6524875
Email address
maryam.raazq@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-20, 1399/08/30
Expected recruitment end date
2021-07-20, 1400/04/29
Actual recruitment start date
2020-12-01, 1399/09/11
Actual recruitment end date
2021-08-30, 1400/06/08
Trial completion date
2021-08-30, 1400/06/08
Scientific title
Comparative effects of mulligan two-leg rotation technique and muscle energy technique on hamstring flexibility, pain and functional disability in patients with chronic non-specific low back pain
Public title
Effect of hamstring flexibility in patients with chronic non-specific low back pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female
Age group eighteen to thirty years of age
Non-specific low back pain for more than three months.
Patients with hamstrings tightness measured by Active Knee Extension (AKE) test with measurement having greater than the thirty-degree loss of knee.
Exclusion criteria:
Low back pain with active systemic or spine pathology.
Upper motor neuron lesion and lower motor neuron lesion
Pregnancy, psychological risk factor or subjects apprehensive for the stretching techniques
History of fracture or surgery of spine, pelvis, hip or knee.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
116
Actual sample size reached:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who were eligible were randomly assigned, using the simple random sampling technique by lottery method. Out of the screened patients, 108 patients who fulfill the inclusion criteria were assigned a number. The walk-in patients were assigned by even numbers and odd numbers. Patients coming at the even numbers were included in Group A (Two Leg Rotation) and those with odd numbers were included in Group B (Muscle Energy Technique). 54 patients were included in Group A and 54 patients were assigned to Group B.
Blinding (investigator's opinion)
Double blinded
Blinding description
The double blinding technique was used. The assessor and participants both were blinded to the given technique. In the end, the study was unblinded and researchers and participants was made aware of the treatment groups in which they were allocated.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics' committee of The University of Lahore, Faculty of Allied health Science
Street address
Defence Road Campus, Bhobatian Chowk, Lahore
City
Lahore
Postal code
54590
Approval date
2020-11-19, 1399/08/29
Ethics committee reference number
IRB-UOL-FAHS/797/2020
Health conditions studied
1
Description of health condition studied
Chronic Low Back Pain with decreased hamstring flexibility
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain intensity
Timepoint
Before the intervention and 2,4 weeks
Method of measurement
Numeric Pain Rating Scale
2
Description
Hamstring flexibility
Timepoint
Before intervention, 2,4 week
Method of measurement
Active knee extension test
3
Description
Functional Disability
Timepoint
Before intervention and 2,4 week
Method of measurement
Modified Oswestary Disability Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (Mulligan Two Leg Rotation): After giving the moist hot pack for 20 minutes at the low back area and hamstrings, the therapist stands at the limited hamstrings flexibility side of the patient lying in a supine position. Both legs were flexed to a level that feet are off the table. After stabilizing the patient shoulders on the bed, the patient’s leg was fully flexed and slowly taken to the side of the limited hamstring muscle flexibility. When the limit was reached, the position was sustained for 30 seconds with overpressure applied by the therapist, and then the legs were lowered to the plinth. Three repetitions were repeated, and 1 minute rest time was given between each stretch. And the same procedure was done for the other side of limited hamstrings flexibility. Total time duration for this technique was 10 minutes.
Category
Rehabilitation
2
Description
Intervention group (Muscle Energy Technique): Post Isometric Relaxation (PIR) of muscle energy technique was used. After applying the moist hot pack for 20 minutes at the low back and hamstrings the patient was instructed to lie in a supine position with the non-treated leg straight on the table. The therapist passively flexed the treated leg at the hip and the patient knee was straightened on the therapist's shoulder until the primary resistance was felt. The patient was instructed to apply pressure for 7-10 seconds on the therapist's shoulder against resistance by using no more than 25% of their strength during isometric contractions. The contraction period was followed by a relaxation period and then the therapist passively straightened the knee towards its new barrier and held it for 30 seconds. The procedure was repeated 4 times with a 10-second rest interval between them. Total time duration for this technique was 10 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Bakhtawar Amin Hospital
Full name of responsible person
Maryam Razzaq
Street address
Northern Bypass, Multan
City
Multan
Postal code
60000
Phone
+92 61 6741001
Email
maryam.raazq@gmail.com
Web page address
https://www.trust.bamdc.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Maryam Razzaq
Street address
Defence Road Campus, Bhobatian Chowk, Lahore
City
Lahore
Postal code
54590
Phone
+92 42 35322501
Email
maryam.raazq@gmail.com
Web page address
https://uol.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
UOL
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
Bakhtawar Amin Hospital
Full name of responsible person
Maryam Razzaq
Position
Senior Therapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House number 486, MDA officers co-operative housing society, Multan
City
MULTAN
Province
Punjab
Postal code
60000
Phone
+92 61 6524875
Email
maryam.raazq@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bakhtawar Amin Hospital
Full name of responsible person
Maryam Razzaq
Position
Senior Therapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House number 486, MDA officers co-operative housing society, Multan
City
MULTAN
Province
Punjab
Postal code
60000
Phone
+92 61 7524875
Email
maryam.raazq@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bakhtawar Amin Hospital
Full name of responsible person
Maryam Razzaq
Position
Senior Therapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House number 486, MDA officers co-operative housing society, Multan
City
MULTAN
Province
Punjab
Postal code
60000
Phone
+92 61 6524875
Email
maryam.raazq@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because patient consent was taken only for this study, so I cannot share the data without their permission.
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
Comparative effects of Mulligan Two Leg Rotation Technique and Muscle Energy Technique on Hamstring flexibility, Pain and Functional Disability in Patients with Chronic Non-Specific Low Back Pain
When the data will become available and for how long
The study is completed and it will be available after publication
To whom data/document is available
To everyone who finds interest.
Under which criteria data/document could be used
Anyone who will request the data,
From where data/document is obtainable
From the Hospital.
What processes are involved for a request to access data/document
Through E-mail address and contact number is given.