Comparative effect of Mulligan two leg rotations and bend leg raise techniques in improving pain intensity and hamstring dynamics in subjects with chronic low back pain
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General information
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Because I have to update recruitment dates
Because I have to update recruitment dates
Protocol summary
Study aim
To check the comparative effects of Mulligan two leg rotations and bend leg raise techniques in pain intensity and hamstring dynamics in subjects with chronic low back pain. Secondary objective was to compare the disability in patients with chronic low back pain.
Design
Single blind, parallel assigned, bi-center, randomized clinical trial that will be done on 34 patients with history of pain for more than 12 weeks. Patients will be assigned by using the lottery method of simple random sampling.
Settings and conduct
Hussain memorial hospital Lahore and The Physiotherapy Clinic of The University of Lahore.
Participants/Inclusion and exclusion criteria
Patients with age from 20 to 45 years. Both male and female were included. Subjects with pain above 3 on numeric pain rating scale. Pain more than 12 weeks. Score more than 30% and less than 65% on the Modified Oswestry disability questionnaire. Subjects not willing to participate. Patients with Sciatica pain.. Fracture of the Lumber, pelvic and all the spinal regions. Slipping of vertebra or complete tears of intervertebral disc. Recent history of trauma within six months. Patients with Surgical History. Radiating pain to the legs and buttocks. Spinal pathologies i.e. degenrative changes, spinal T.B, discitis, Osteoporosis and neoplasm. Disc herniation at any spinal region. Females with Pregnancy.
Intervention groups
Group A: Warmup before the treatment will be given as baseline treatment. Mulligan two leg rotation technique will be applied. Group B: As a baseline treatment warmup before the treatment will be done by the use of hot pack. Then the bend leg raise technique will be applied.
Main outcome variables
Pain intensity, Hamstring Flexibility on both sides and disability
General information
Reason for update
Because I have to update recruitment dates
Acronym
IRCT registration information
IRCT registration number:IRCT20210813052159N1
Registration date:2021-08-24, 1400/06/02
Registration timing:prospective
Last update:2021-10-10, 1400/07/18
Update count:1
Registration date
2021-08-24, 1400/06/02
Registrant information
Name
Abdul Samad
Name of organization / entity
The University of Faisalabad and The University of Lahore
Country
Pakistan
Phone
+92 46 2528198
Email address
abdulsamad2488@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-25, 1400/06/03
Expected recruitment end date
2021-09-05, 1400/06/14
Actual recruitment start date
2021-08-27, 1400/06/05
Actual recruitment end date
2021-09-07, 1400/06/16
Trial completion date
2021-10-10, 1400/07/18
Scientific title
Comparative effect of Mulligan two leg rotations and bend leg raise techniques in improving pain intensity and hamstring dynamics in subjects with chronic low back pain
Public title
Comparison of Mulligan techniques in chronic low back pain patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
• Patients with age from 20 to 45 years
• Both male and female were included
• Subjects with pain above 3 on numeric pain rating scale.
• Pain more than 12 weeks
• Score more than 30% and less than 65% on the Modified Oswestry disability questionnaire
Exclusion criteria:
• Subjects not willing to participate
• Patients with Sciatica pain
• Fracture of the Lumber, pelvic and all the spinal regions
• Slipping of vertebra or complete tears of intervertebral disc
• Recent history of trauma within six months
• Surgical History
• Radiating pain to the legs and buttocks
• Spinal pathologies i.e. degenrative changes, spinal T.B, discitis, Osteoporosis and neoplasm
• Disc herniation at any spinal region
• Pregnancy
Age
From 20 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
34
Actual sample size reached:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be randomly assigned, using the simple random sampling technique by lottery method. Out of the screened patients, 34 patients those who fulfill the inclusion criteria were assigned a number. The walk-in patients will be assigned by even numbers and odd numbers. Patients coming at the even numbers will be included in Group A (Two Leg Rotation) and those with odd numbers will be included in the Group B (Bend Leg Raise). 17 patients will be included in the Group A and 17 patients will be assigned to the Group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Information about the details of both programs will not be provided except for similarities across both groups (exercise regime). Both programs will be personalized to the patient’s abilities to ensure all eligible patients could complete the program. Patients will not be informed about the treatment protocols within the group they are enrolled in. Patient will not be aware whether they are included in the Group A or Group B and they will not be aware that they are receiving Two Leg Rotation or Bend Leg Raise technique within the group. Patient will not be aware of the maximum outcome measures possible after the treatment. Within two groups, the treatment will be given at the hospital or rehabilitation clinic during the one-hour therapy session.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics and Technical committee of The University of Faisalabad
Street address
University town, Sargodha road Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2021-05-25, 1400/03/04
Ethics committee reference number
TUF/DR/SA/MSPP/2021/237-246
Health conditions studied
1
Description of health condition studied
Chronic Low Back Pain patients 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, after 4 weeks of intervention
Method of measurement
Numeric Pain Rating Scale
2
Description
Hamstring flexibility
Timepoint
Before the Intervention, after 4 weeks of intervention
Method of measurement
Active Knee Extension Test
Secondary outcomes
1
Description
Disability in Low back pain patients
Timepoint
Before the treatment, 4 weeks after the treatment
Method of measurement
Modified oswestary disability questionnaire
Intervention groups
1
Description
Intervention group: Group A (Mulligan Two Leg Rotation) Patient will be in supine lying and therapist will stand on the limited side of hamstring flexibility. Therapist will move both the legs into hip flexion and knee flexion to the maximum until both the feet are off the table. Upper extremity of the patient will fixed to the plinth by using the belt or assistant. Then both the legs will be moved to the limited hamstring flexibility side. Upon reaching the limit this position will be maintained for 30 seconds and over pressure may be applied. 3 repetitions will be given and same procedure will be applied on the other side. Devices used will be Mulligan belts and plinths.
Category
Treatment - Other
2
Description
Intervention group: Group B (Mulligan Bend Leg Raise) Patient will be in supine lying position. Knee will be placed on the therapist shoulder in 90-degree hip and knee flexion. Therapist would be standing on the patient side which is going to be treated. Both the hands will be placed on the lower end of thigh. Knee would rest on the therapist shoulder under the popliteal fossa and distraction will be added along the longitudinal axis of femur by using the both hands. Ask the patient to push against the shoulder with his leg and then asked to relax voluntarily. During this relaxation period bent knee will be pushed through its available range in the direction of shoulder in pain free range. Stretch will be maintained for 30 seconds and 3 repetitions will be given. If the pain is decreased and range of motion increased the hip will be moved into more flexion and procedure will be repeated. Devices used will be Mulligan belts and plinths.