Immediate Effect of Mulligan Two Leg Rotation and Bent Leg Raise Techniques on Hamstring Tightness

April 11, 2022 updated by: Riphah International University

Compare Immediate Effect Of Mulligan Two Leg Rotation And Bent Leg Raise Techniques On Hamstring Tightness And Core Muscle Weakness In Chronic Low Back Pain

The aim of this study is to compare the immediate effect of mulligan's two leg rotation and bent leg raise for hamstring tightness, core muscle weakness in chronic low back pain, lumbar Range of motion. A randomized control trial is being conducted at Women Institute of Rehabilitation Sciences Abbottabad. It consisted of 68 participants with moderate chronic low back pain 4-6 on VAS scale, weak back extensors, and abdominal muscle weakness .and hamstring tightness. 34 patients in Group A is receiving moist heat for the hamstrings muscles prior the Mulligan Two leg rotation technique for 10mins .core muscle strenthening exercises for back extensors and abdominals. 34 patients in Group B is receiving moist heat for the hamstrings muscles prior the Mulligan Bent leg raise technique for 10 minutes.Study duration was of 6 months. Sampling technique being applied is purposive.Study includes patients with mechanical LBP more than 3 months.Tools being used in the study are Goniometer, Measuring tape, Pressure Biofeedback Unit, Visual analogue scale (VAS), Mulligan's belt. Data is being analyzed through SPSS 21.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The term Low Back Pain (LBP) refers to pain in the lumbo-sacral area of the spine from 1st lumbar vertebra to the 1st sacral vertebra. Low back pain (LBP) can be caused by different varieties of problems with any parts of the complex, interconnected network of spinal muscles, nerves, bones, discs or tendons in the lumbar spine.The stability and support of the trunk area is mainly dependent on strength of supporting structures, the muscles. Weak back extensor muscles can result improper vertebral alignment which may lead to undue loading on the spine. Causes of low back pain can be due to many factors, for example: individual characteristics, working environment such as heavy physical work, awkward static and dynamic working postures, as well as manual handling and lifting, lifestyle factors and psychological factors. It can also be caused because of muscle sprain, ligament sprain, poor posture, age, disc bulge, other causes of low back pain include bladder/kidney infection, endometriosis, cancer, or ovarian problems Hamstring muscles are comprised of three semitendinosus, semimembranosus and biceps femoris. They are located on the posterior compartment of the thigh. Hamstring muscles are two joint muscles of body its function is hip extension and knee flexion. Injury rate within hamstring muscle, is the long head of biceps femoris that is frequently injured and accounts for approximately 80 % of all hamstring injuries. Flexibility is the most important component of physical fitness. Normal flexibility allows the person to move smoothly and safely . For normal movement and locomotion flexibility of muscle is important. It will help a person for normal body function. The flexibility of hamstring muscle is always emphasized more. The Hamstring muscle is the most common muscle to always go for tightness. The tightness of this muscle apparently increases from childhood up to the age of 40-49 years. Tight hamstring muscles causes a major effect on body's normal postural alignment. Till date studies have shown that tightness of hamstring always led to low back pain with lumbar intervertebral disc pathologies. Biomechanically tightness of hamstring muscle is thought to increase patellofemoral joint compressive forces because of increase in passive tension at the time of the swing phase of ambulation under rapid and stressful situations hamstring muscles fails to pass through full physiological amplitude when specifically this muscle goes for tightness.

The "core" has been described as a muscular box with the abdominals in the front, Para spinals and gluteal in the back, the diaphragm as the roof, and the pelvic floor and hip girdle musculature as the bottom. Chronic low back pain (CLBP) is a complex condition which is mainly associated with back (multifidus) abdominal (transversusabdominis) and hip (Gluteus Maximus) muscles dysfunction along with reduced lumbar flexibility Mulligan Bent Leg Raise is a newer technique which has been developed to manage hamstring tightness. This stretching technique is painless and is recently utilized in the management of hamstring tightness with limitation of straight leg raise. The Mulligan bent leg raise (BLR) technique has been described as a means of improving range of straight leg raise (SLR) in subjects with LBP and/or referred thigh pain (Mulligan, 1999). The intention of this technique is to restore normal mobility and reduce LBP and physical impairment. Impairment is defined as abnormalities of structure or function, as indicated by signs or symptoms .

Mulligan's Two Leg Rotation Technique(TLR) is also a painless technique, and it can be applied to any subjects having hamstrings tightness, low back pain or limited and/or painful straight leg raise (SLR).It can be extremely useful in patients who have a gross bilateral limitation of straight leg rising. TLR Technique is a new technique that has been developed by Dr. Brain R Mulligan and colleagues.

Toby Hall ,Sonja Hardt ,Axel Schäfer, Lena Wallin conducted a study in 2006 to investigate the immediate effects, on range of motion and pain, of Mulligan's bent leg raise (BLR) technique in subjects with limited straight leg raise (SLR) and low back pain (LBP). the study reveals that there was a significant increase in the range by 7° in the BLR group, which may be clinically important.

Pratik A. Phansopkar and Vijay Kage in 2014 conducted a study to evaluate the effectiveness of Mulligan's TLR technique for hamstrings flexibility in acute non-specific low back pain. The Results of the study were focused on Pain relief, decrease in the functional disability due to low back pain. Their study demonstrates that, Mulligan's Two Leg Rotation technique is effective in increasing the hamstrings flexibility in subjects with low back pain in terms of pain, range of motion and functional disability In 2015 Tarun Kumara, Suraj Kumarb, Md. Nezamuddinc and V.P. Sharmad conducted a study to evaluate the Efficacy of core muscle strengthening exercise in chronic low back pain patients. This study concluded that core muscle strengthening exercise is an effective rehabilitation technique for all chronic low back pain patients.

A study conducted in 2018 to investigate the Effectiveness of bent leg raise v/s two leg rotation in patients with low back pain. The study was designed to compare the immediate effects of two manual techniques in patients with low back pain. The study showed that both BLR and TLR techniques were equally effective in reducing LBP. But clinically group A bent leg raise technique showed more effective in reducing low back pain and improving ROM than group B two leg rotation.

In 2016, Parag P Kulkarni., Ankita Devasthali., Ajay Kumar and Satish Pimpale conducted a study to compare effectiveness of mulligan bent leg raise v/s knee to chest McKenzie for hamstring tightness. Their study concluded that Bend Leg raise technique of Mulligan was found to be more effective than Knee to the chest of McKenzie.

A study conducted by Shrinivas Vinayakrao Shinde, Smita Bhimrao Kanase showed that the active knee extension and straight leg raise was statistically extremely significantly improved in participants treated with mulligan bent leg raise. This improvement is mainly attributed to change in stretch tolerance of the hamstring muscle. It may also be assumed that bent leg raise triggers neurophysiological responses influencing the muscle stretch tolerance.Thus, there was improvement in active knee extension and straight leg raise range in participants.

Rina, Shamima Nasrin in 2016 conducted a study to investigate the Effectiveness of bent leg raise exercise along with conventional physiotherapy comparing with conventional physiotherapy alone for the patients with chronic radiating low back pain. Their experimental study showed that Bent Leg Raise Exercise with conventional physiotherapy was more effective than conventional physiotherapy alone for patients with chronic radiating Low Back Pain C Romani-Ruby investigated that the performance of core stability would result in increased flexibility of the hamstring musculature and vice versa. Core stability exercise programs target these muscles to help improve the overall function of the spine and body during activities of daily living, where it provides "proximal stability for distal mobility. More recent research demonstrates a significant correlation between core stability and the range of motion of the Lower extremities, specifically the hamstrings.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Kpk
      • Abbottabad, Kpk, Pakistan, 22010
        • Women Institute of Rehabiltation Sciences Abbottabad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The study includes female patients with moderate chronic low back pain 4-6 on VAS scale, weak back extensors, and abdominal muscle weakness .and hamstring tightness.
  • Study included patients with mechanical LBP more than 3 months.
  • Limited SLR more than 300, hamstring tightness range between 60 - 90o.

Exclusion Criteria:

  • Subjects with LBP with trauma.
  • LBP with specific pathology.
  • Any neurological Symptoms involving prolapsed intervertebral disc, radiating pain.
  • History of any recent abdominal, back Surgeries.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: mulligan two leg rotation , core muscle strengthening exercises
Group A :is receiving moist heat for the hamstrings muscles prior the Mulligan Two leg rotation technique for 10mins.Hold the position for 30 seconds, relax for 1 minute. Reps are given 3 repetitions. And 3 Sets at each session .core muscle strenthening exercises for back extensors and abdominals i.e Bridge curls ,table top ,abdominal crunches,back extension with arms supporting, is being performed. Position is being held for about 10 seconds and each exercise are performed with 10 repititions. Patient is being relaxed for 3 seconds between repetitions and 60 second rest between each exercise
Other: Mulligan two leg rotation core muscle strengthning exercises
Group A :is receiving moist heat for the hamstrings muscles prior the Mulligan Two leg rotation technique for 10mins.Hold the position for 30 seconds, relax for 1 minute. Reps are given 3 repetitions. And 3 Sets at each session .core muscle strenthening exercises for back extensors and abdominals i.e Bridge curls ,table top ,abdominal crunches,back extension with arms supporting, is being performed. Position is being held for about 10 seconds and each exercise are performed with 10 repititions. Patient is being relaxed for 3 seconds between repetitions and 60 second rest between each exercise
EXPERIMENTAL: Mulligan bent leg raise technique core muscle strengthning exercises.
Group B is receiving moist heat for the hamstrings muscles prior the Mulligan Bent leg raise technique for 10 minutes. Hold the position for 30 seconds, relax for 1 minute. Reps are 3 repetitions. And 3 Sets at each session .Subject is being receive 2 weeks protocol. core muscle strenthening exercises for back extensors and abdominals i.e Bridge curls ,table top ,abdominal crunches,back extension with arms supporting, are being performed. Position is held for about 10 seconds and each exercise is performed with 10 repititions. Patient is being relaxed for 3 seconds between repetitions and 60 second rest between each exercise
Other: mulligan bent leg raise technique, core muscle strengthning exercises
Group B is receiving moist heat for the hamstrings muscles prior the Mulligan Bent leg raise technique for 10 minutes. Hold the position for 30 seconds, relax for 1 minute. Reps are 3 repetitions. And 3 Sets at each session .Subject is being receive 2 weeks protocol. core muscle strenthening exercises for back extensors and abdominals i.e Bridge curls ,table top ,abdominal crunches,back extension with arms supporting, are being performed. Position is held for about 10 seconds and each exercise is performed with 10 repititions. Patient is being relaxed for 3 seconds between repetitions and 60 second rest between each exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ROM Hip, Knee extension
Time Frame: 2 weeks

Changes from the baseline ROM of hip flexion and knee extension are being taken with the help of goniometer.

Normal Values for Range of Motion of Hip joint in flexion with goniometer ranges from 0 -1250.

For Active knee extension , knee flexion angle should be of greater than 150.
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Core muscle strength
Time Frame: 2 weeks and 1 month follow up
Changes from the baseline strength of Abdominals and back extensors are being taken with the help of Pressure Biofeedback Unit. The bulb inflated to 40 mmHg of pressure and maintained .The measuring range is from 0 to 200 mmHg analog pressure with an accuracy of +/- 3mmHz pressure. pressure increase of 0, 2, 4, or 6 mmHg from the initially maintained 40 mmHg.
2 weeks and 1 month follow up
Visual Analogue scale
Time Frame: 2 weeks
Changes from base Visual Analogue scale (VAS) is a scale for pain starting from 0-10. where 0 indicate no pain , 4 to 7 indicate mild to moderate pain and 10 indicate severe pain.
2 weeks
ROM lumbar spine
Time Frame: 2 weeks

ROM Lumbar Spine ( Flexion) The normal ROM range for lumbar flexion ranges from 6.3cm - 6.9cm.

ROM Lumbar Spine ( Extension ) The normal ROM range for lumbar extension ranges from 1.6cm.

ROM Lumbar Spine ( rotation ) .normal range for rotation is 100.with measuring tape it is measured by point of marking .

ROM Lumbar Spine ( right side bending ) The normal ROM range for lumbar SB ranges from 25 - 300.

ROM Lumbar Spine ( left side bending) The normal ROM range for lumbar SB ranges from 25- 300.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Saira Waqqar, PHD*, saira.waqar@riphah.edu.pk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC00772 Sania Tanveer Qazi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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