Myofascial release versus Mulligan sustained natural apophyseal glides’ immediate and short-term effects on pain, function, and mobility in non-specific low back pain

Background Myofascial release (MFR) and Mulligan Sustained Natural Apophyseal Glides (SNAGs) are manual therapy techniques routinely practiced in the management of non-specific low back pain (NSLBP). As a solo intervention or along with other therapies, both methods have reported positive results for individuals with NSLBP. However, which technique improves NSLBP-related pain, restricted range of motion (ROM) and disability, warrants further research. Objective To study the comparative effects of MFR and SNAGs on pain, disability, functional ability, and lumbar ROM in NSLBP. Method A parallel-group study was conducted at tertiary care hospitals. Sixty-five Sub-acute or chronic NSLBP patients were allocated to receive strengthening exercises along with either MFR (n = 33) or SNAGs (n = 32) for six treatment sessions over one week. An independent assessor evaluated outcome measures such as the Visual Analog Scale (VAS), Patient-Specific Function Scale (PSFS), and ROM at baseline, immediate (after 1st treatment), and short-term (post-sixth day of the intervention). The Modified Oswestry disability index (MODI) was assessed at baseline and short-term. Results Within-group analysis found clinically and statistically significant (p < 0.05) changes for VAS and PSFS at immediate and short-term for both the groups. The lumbar extension also showed improvement immediately and in the short-term. Improvement in Lumbar flexion was seen only in the SNAGs group over the short-term. A statistically significant improvement was seen for MODI in both the groups but was not clinically significant in the MFR group. The analysis observed no statistically significant difference (p < 0.05) between the groups at both the immediate and short-term. Conclusions Pain and restricted function associated with NSLBP can be improved using SNAGs or MFR, along with strengthening exercises. For limited lumbar flexion ROM, Mulligan SNAGs have a better outcome than MFR over the short-term. Hence, both manual therapy techniques can be incorporated along with exercises for immediate and short-term management of sub-acute to chronic NSLBP. Clinical Trial Registration. CTRI/2018/12/016787 (http://ctri.nic.in/Clinicaltrials/).


Introduction
Low back pain (LBP) is the leading cause of years lived with disability in both developed and developing countries. 1 Low back pain is considered as a debilitating musculoskeletal health condition, ranked first in terms of disease burden worldwide. 2 The global age-standardised point prevalence of LBP (from 0 to 100 years of age) in 2010 was estimated to be 9.4%, the mean point prevalence of LBP was estimated to be 18.3%, and one month prevalence was 30.8%. 3 Low back pain is defined as pain in the area on the posterior aspect of the body from the lower margin of the twelfth ribs to the lower gluteal folds with or without pain referred in to one or both lower limb. 3,4 Low back pain is broadly classified as specific LBP and nonspecific LBP (NSLBP). 1,3,4 A known identifiable pathology is called as specific LBP and NSLBP is back pain of unknown underlying pathology which is characterised by pain, muscle tension and stiffness. 1,4 Nonspecific LBP severely limits activities of daily living, induce substantial medical consumption resulting in prolonged disability. 1,2 Low back pain can be categorized in to, acute LBP which lasts for less than 6 weeks, sub-acute LBP lasts for between 6 weeks and 3 months and chronic LBP has a duration of more than 3 months. 4 The proposed pathomechanics of NSLBP attributed to changes in lumbosacral proprioception, core muscle recruitment patterns, macroscopic degeneration of lumbar stabilisers, abnormal tissue loading and weakness of both gluteal and paraspinal muscles. The evident depletion of lumbar motor control in NSLBP leads to uncontrolled movements, this altered abnormal movement pattern increases tissue stiffness which stresses lumbar spine, causing pain exacerbation. 5 The primary management being pain reduction, NSLBP also focuses on patient education, analgesic medication, non-medical therapy and timely review. 6 Non-medical physical and rehabilitation interventions include Manual therapy, 7 back schools, exercises, electrical modalities and multidisciplinary rehabilitation. 6 Manual therapy is forms of hands-on soft tissue or joint mobilization techniques to modulate pain and also improve extensibility of contractile tissues and improve restricted movement of joints. 7 Manual therapies such as Mulligan mobilization, Maitland mobilization, myofascial release therapy are used routinely in clinical practice and have shown high evidence of its effectiveness of the treatment in NSLBP. 8 The Mulligan concept is based on the minor position faults of articulating surfaces of joint following injury or strain resulting in painful and restricted range of motion (ROM). 7,8 Mulligan concept includes natural apophyseal glides (NAGs), sustained natural apophyseal glides (SNAGs) and mobilizations with movement (MWMs). 7,9 Sustained natural apophyseal glides is a technique that involves application of passive accessory glide parallel to the joint plane using the spinous process or transverse process of the vertebra while the subject simultaneously executes an active movement which was previously painful or restricted. [7][8][9][10] Two studies were found and replicated in a systematic review among NSLBP, one of the study results showed added effects of SNAGs to conventional therapy improved pain perception and function. 7,8,10 The study also showed the treatment had an immediate and short term improvement in lumbar flexion ROM among NSLBP 7,10 and healthy individuals. 11 In another study, SNAGs found to improve lumbar flexion ROM when SNAGs and McKenzie extension exercises were compared among chronic mechanical LBP populations. 12 Myofascial release (MFR) is a manual therapy treatment that involves guided low load, long duration mechanical forces to manipulate the myofascial complex, aiming to restore optimal muscle length, decrease pain, and improve function as it is effective to provide immediate relief of pain and tissue tenderness. 13,14 exercise alone in LBP. 13,14 MFR also found to be effective in improving pain perception, releasing impaired sliding fascial mobility 13,15 and functional abilities 16  showed an evidence that MFR when used as an adjunct to SBE is more effective than a control group with SBE for chronic LBP. 13,14 Tozzi .P et.al studied pain perception and the mobility of fascial layers by using a dynamic ultrasound (US) in patients with NSNP and NSLBP. 60 patients each with NSNP and NSLBP were divided into experimental and control groups. The results found that MFR can improve impaired fascial mobility when analysed using US, and also pain perception over a short term duration in NSNP and NSLBP compared sham control group. 13

Knowledge gap identified
There was only one study which had short term effects on pain, ROM and functional abilities on comparing SNAGs and MFR in NSNP. Therefore the study intends to find similar effects on NSLBP population on comparing SNAGs and MFR.

Aim of the study
To compare the effects of myofascial release and sustained natural apophyseal glides among nonspecific low back pain Sampling method: Block randomisation-Subjects will be divided into subgroup called blocks in which a set of 6 blocks will have 4 combination each. The subjects in each block will be randomly allocated into either SNAGs or MFR group will be enclosed in a concealed opaque envelope.

Tester
A qualified physiotherapist pursuing his master's degree in Physiotherapy at KMC Mangaluru will conduct the study under the guidance of Assistant professors, Department of Physiotherapy

Assessor
An independent assessor who is a qualified physiotherapist at KMC, Mangaluru, blinded from allocated treatment groups will measure the pre and post intervention outcomes of the study participants.

Inclusion criteria
 Subjects with nonspecific low back pain

Procedure
The study protocol will be submitted to the Scientific Committee and Institutional Ethics Committee of KMC Mangaluru, Manipal Academy of Higher Education (MAHE) for approval. Upon approval, the subjects referred or non-referred by Orthopedician to the Department of Physiotherapy will be approached. The informed consent will be taken from the willing subjects and the purpose of the study will be explained. Post screening for inclusion criteria, eligible subjects will be allocated into two either SNAGs or MFR group by block randomisation. Demographic data and baseline data for VAS, PSFS, ODI and ROM will be collected.

Procedure for SNAGs
SNAGs will be administered based on the clinical presentation of the patient. ASIS of patient will be stabilized by the therapist using a belt around his hip joint. The ulnar border of the hand will be placed according to the pain presentation i.e. for Flexion range restriction the hand will be placed inferior to spinous process of vertebrae to involved segment where for extension hand will be placed superior to the spinous process of vertebrae. Thumb is placed over transverse process for unilateral presentation of pain. The patient then asked to perform the movement which elicits pain and backs off, then the therapist applies a parallel passive accessory glide to facet joint plane over the segment and patient will be asked to perform the movement which was painful before and then return to the starting position while the therapist maintain his mobilizing force until the end. If the movement is pain free throughout the range then therapist is on correct level if not then change the level. The glides will be applied 6 repetitions for 3 sets to improve the ROM and reduce pain.

Procedure for MFR
A gross stretch (MFR) will applied over the poster aspect of the body and the traction will be maintained to hold the tissue at its end range at least 90 to 120 seconds before the tissue will begin to soften and lengthen, The stretch will be held until the therapist feels giving way of taut tissue.

Procedure to measure outcomes
To measure pain, the patient will be administered 100mm Visual Analog Scale (VAS) and asked to mark a point on the scale based on his/her pain intensity, The VAS score for pain will be measured from left hand end of line to point patient marks.
To measure functional ability, the patient will be asked to write down the 3 activities which restrict or unable to do routine activity and will be asked to rate score between "0 to 10" for each activity where 0 is unable to perform/difficult to do and 10 is able to do as before.
To measure disability level, the patient will be given with the questionnaire and asked to tick appropriate option in all the 10 sections. This questionnaire has been designed to give information how low back or leg pain is affecting ability to manage in everyday life.
To check ROM, mark the spinous processes of the T12 and S2 vertebrae using a skin marking pencil, with the patient in the standing position. Place one inclinometer over the spinous process of T12 and the second inclinometer over the midline of the sacrum at S2. Then zero both inclinometers. For flexion ask the subject to bend backward as far as possible and for extension ROM ask the subject to bend backward as far as possible. To measure lateral flexion range of motion, ask the subject to bend the trunk laterally while keeping both feet flat on the ground and the knees straight. Maintain the inclinometers firmly against the spine during the motion. Read and record the degrees from both inclinometers at the end of the motion. Subtract the degrees on the sacral inclinometer from the degrees on the T12 inclinometer to obtain the lumbar flexion and extension and lateral flexion ROM respectively.
Core strengthening exercises (lumbar multifidus and transverse abdominis) and gluteal muscle strength training and ergonomic advices about posture and lifting techniques will be given to incorporate regularly at home.
The outcome measures will be taken from patients immediately after the treatment and final readings will be taken on the last day of the follow-up.
Outcome variables: -Pain, Range of motion, Disability, Functional status Data analysis:- Data will be analyzed using SPSS version 17.0  Student's unpaired t-test will be used between the groups  ANOVA with Post-Hoc test and Bonferroni's t-test will be applied across the groups  p value <0.05 will be considered as statistically significant

PURPOSE OF RESEARCH
To compare the immediate and short term effects of MFR and SNAGs in nonspecific low back pain.

PROCEDURE OF THIS STUDY
I understand that in this study, range of motion will be assessed, I have to complete the questionnaires given and then treatment will be provided. The study will be carried out for total 6 sessions.

BENEFITS OF THE STUDY
Results may act as substitute/alternative therapy to reduce pain, disability and improve lumbar range of motion

RISK AND DISCOMFORT
I understand that I may experience some discomfort while undergoing the evaluation and treatment. The entire procedure is safe and without any side effects CONFIDENTIALITY I understand that the medical information produced by this study will be kept confidential. If the data is used for publication in the medical literature or for teaching purpose; names and other identifiers will not be used without my permission. College for any clarification and further study. The copy of consent form will also be given to me.

REFUSAL OR WITHDRAWAL OF PARTICIPANT
I understand that my participation is voluntary and that I may refuse to participate or may withdraw consent and discontinue participation in the study at any time.

INJURY STATEMENT
I understand that in case of any injury to me resulting directly from my participation in the study, medical treatment would be available, but no financial compensation would be provided for the same. I also understand that VIGNESH BHAT P may also terminate my participation in the study at any time without any reason.
I have explained to __________________________the purpose of the research, the procedure, benefits and the risk factors associated with the study with my best ability.