A chronic low backache is one that lasts longer than three months. In contrast to acute low back pain, which lasts shorter than six weeks, subacute low back pain lasts between six weeks and six months. ¹ Low back pain (LBP) is described as pain that lasts for at least a day in the lower back area between the lower limit of the 12th ribs and the lower gluteal folds, with or without discomfort radiating to one or both lower limbs. The most prevalent musculoskeletal condition globally is LBP. ²

Epidemiological studies show that LBP is the most common type of chronic pain, affecting 70–80% of people experience life's events at some point. ³ Back pain (BP) may be divided into three primary categories. An acute case of pain is one that lasts less than six weeks, a subacute case is one that lasts between six weeks and three months, and a chronic case is one that lasts more than three months. ⁴

The most frequent musculoskeletal ailment affecting people is low back pain (LBP), occurring up to 84% of the time. A frequent complaint among people is back ache. Some studies estimate that up to 23% of people worldwide experience chronic LBP. Another finding for this group was a 24% to 80% one-year recurrence rate. CLBP, a significant social and economic issue, is the primary cause of disability globally. ⁵

In many parts of the world, low back pain is both a significant financial burden and the most common reason for activity restriction, time away from work, and disability. ⁶

According to one study, back pain cumulative incidence reached 50% by the ages of 18 for females and 20 for males, with a point prevalence of around 1% for children aged 12 and 5% for children aged 15 years. ⁷

A mechanical back is something that happens regularly and frequently. Up to 30% of mechanical back pain may be caused by the sacroiliac joint, according to some research, however differential diagnostics typically rule this option out. ⁸

Specific low back pain and nonspecific low back pain (NSLBP) are the two main types of LBP. Low back pain may be categorised into two groups: vertebral-related and non-vertebral-related. NSLBP, on the other hand, is a kind of low back pain where the relationship between the symptoms, physical findings, and imaging data is unclear. Additionally, NSLBP is separated into two groups: Degenerative syndrome and low back discomfort unrelated to a neurological condition. The three sub-groups of low back pain are acute, subacute, and chronic that are typically used to classify non-specific low back pain. This divide is based on how long the back discomfort has been there. ⁹

Back pain can have a number of various causes, including: Mechanical: Typically, soft tissues, intervertebral discs, or the spine have been injured. Lumbago is frequently diagnosed as an acute backache or a quadratus lumborum or paraspinal muscle strain. A typical kind of traumatic back pain is disc herniation. Back pain can also be mechanically brought on by pregnancy.

Degenerative: Degenerative disc disease, spinal stenosis, and facet joint osteoarthritis are all forms of osteoarthritis of the spine.

Inflammatory: The primary causes of this disorder are spondyloarthropathies such ankylosing spondylitis. The most typical occurrence is sacroiliitis. Infectious diseases include muscular/soft tissue abscesses, epidural or spinal abscesses. ¹⁰ Mechanical low back pain is a term used to describe back pain that is inherently caused by the spine, discs between the vertebrae, or nearby soft tissues. This includes spinal compression fractures, disc herniation, spondylolysis, lumbar spondylosis, and spondylolisthesis, and lumbosacral muscle strain, in addition to recent or current trauma. ¹⁰

Short-term bed rest is recommended for acute patients getting conservative therapy, but is not recommended for chronic patients. Movement, especially active movement, is a need for good recovery. People with persistent low back pain can be treated using a variety of physiotherapy and rehabilitation treatments, such as hydrotherapy, electrotherapy, massage, thermotherapy, manual therapy, traction, and workout. Patients who experience chronic low back pain should exercise often. Exercises specifically designed for the patient include McKenzie extensions, dynamic stabilisation activities, aerobic exercises, flexion-extension exercises, strengthening exercises, and flexibility exercises. ¹¹

One of the physiotherapy-rehabilitation procedures, manual therapy, has seen a considerable rise in utilisation in clinical settings in recent years. physical treatment programmes are multimodal rehabilitation regimens used in physiotherapy to give patients with tailored care. They usually include physical treatment as well as exercise, training, and counselling. ¹² A recent systematic review found that between 1.5% and 36% of people will experience At some point each year, low back discomfort, while the chance of suffering low back pain for the first time in a year is predicted to be between 6.3% and 15.3%. ¹³

Exercise in conjunction with non-drug therapy should be given priority for those who experience ongoing low back discomfort. The ACP recommends combining several therapies with exercise, such as acupuncture, progressive relaxation, electromyographic biofeedback, tai chi low-level laser treatment, and stress reduction techniques based on mindfulness. ¹⁴

“The exercise known as “William's flexion,” also known as the “lumbar flexion exercise.” For individuals with significant lumbosacral lordosis who had recurrent low back pain and were male or female younger than 40 or 50, William's flexion exercise plan was developed in 1937. Williams recommended that the patient carry out exercises and follow posture guidelines that lessen lumbar lordosis, lessening stress on the posterior components of the lumbar spine. ¹⁵

The William Flexion Exercise, in particular the maximum gluteus and abdominal muscles, is designed to strengthen the lumbosacral spinal muscles and cure back pain by stretching the extensor muscle groups. ¹⁶

Here we aim about this study for testing the Effect of William Flexion exercise and Movement Control exercise on Pain, Range of Motion, Muscle Strength and Functionality on subject with Non-Specific Low Back Pain (NSLBP) in a two arm parallel superiority randomized clinical trial (RCT) on reducing pain and enhance muscle strength and reducing disability in end point results on marginal difference.

Single Centric, two arm parallel equivalence randomized controlled trial.

Ethical approval received from Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha

IEC reference number - DMIHER (DU)/IEC/2023/546

IEC approval date - 04/02/23

CTRI number - CTRI/2023/04/052076

CTRI registration date - 27/04/23

Inclusion criteria

1)

Both male and female participant aged between 18 to 40 years

Exclusion criteria 1)

Specific low back pain (fracture, carcinoma,) sensitivity or reflex loss, muscle weakness.

Non-specific low back pain patient reporting in the Department of Musculoskeletal OPD, AVBRH Sawangi, A total of 74 participants who meet the inclusion criteria and are split into two groups will participate in the study. There will be two groups with 37 patients in each group:

Patient will be assigned with the treatment of Williams Flexion exercise for 30-40 minutes with six sessions a week for four weeks of 30 repetitions of three sets along with IFT for 20 minutes and home exercise program with ten repetitions of one set with 30 sec holds.

Patient will be assigned with the treatment of Movement control exercise for 30-40 minute with six sessions a week for four weeks of 30 repetitions of three sets along with IFT for 20 minutes and home exercise program with 10 repetitions of one set with 30 sec holds. The patient will be selected from the Department of Musculoskeletal OPD of Non-specific low back patient between the age 18-40 years will be selected for the study.

The study will be described to every participant, and their signed informed consent will be obtained. A straightforward random sample will be used to choose the subjects. procedure, and they will be divided into two groups, Group A and Group B, based on inclusion and exclusion criteria. There will be 37 subjects in each group.

Interferential therapy - Prior to receiving therapy, each patient will have their skin feeling evaluated. The individual will be exposed to interferential current while resting on their back for 20 minutes, six times each week for four weeks. The two-pole electrodes will cover the painful lumbar area and/or spinal nerve root electrodes will be attached to the patient's skin to stimulate underlying nerves, including the nerves that carry pain. Along with the IFT, each subject will be given treatment of 30-40minute session of William flexion exercises. Pelvic tilt, single knee to chest, double knee to chest, half sit-up, hamstring stretch, hip flexor stretches, and squat are a few of the exercises. They will be carried out as follows:

The Williams flexion exercises can be performed repeatedly and for varying amounts of time. The suggested time frame for the workout will be every day for 30 to 40 minutes. Treatment program included six sessions a week for four weeks. Each exercise included ten sec hold 30 repetitions × three sets.

In the supine position, the patient will do exercises while lying on a flat surface. Following that, the patient will stretch their legs by keeping their knees close to their chest. The patient will unwind and do the action again. Below is a sample of one of the several exercises. •

The posterior pelvic tilt - The patient will be lying face down, their head will be supported, their legs will be bent, and their hands will be by their sides. The patient will be told to lie on their back flat on the ground. by contracting their buttock and abdominal muscles and hold for ten seconds

Home exercise program will be taught to the patients which include: 1.

Hip flexor stretching - Patient will be ask to draw one leg to the chest to maintain the back flat while they will be in supine and to let the other thigh hang over the side of the bed with ten reps of one set with 30 sec hold.

I nterferential therapy

Prior to receiving therapy, each patient will have their skin feeling evaluated. The individual was exposed to interferential current while lying face down for 20 minutes, six times every week, for a period of four weeks. The two-pole electrodes will cover the painful lumbar area and/or the spinal nerve root. The patient will have electrodes applied to their skin to activate deeper nerves, such as the ones that process pain. Each individual had a 30- to 40-minute session of movement control exercises in addition to the IFT.

The Movement control exercise will be explained to the participants, and they received guidance on the appropriate exercise intensity. Exercises will carry out under the physical therapist's supervision. According to the physical therapist's choice, movement control exercises will also give in the seated, four-point kneeling, and upright postures.

Over the course of the six therapy sessions, the exercises' difficulty level increased while participants will urge to raise their own performance. IFT will be included in each session, which lasted 30 to 40 minutes. The average personal training regimen included three sets of 30 repetitions. The participant's exercise programme during the most recent intervention session included 10 to 12 distinct activities and will be lasted for a total of 30 to 40 minutes. Throughout the intervention and follow-up phase, home workouts will be done three times per week.

Home exercise program will be taught to the patients which include: 1.

Hip flexor stretching- Patient will be ask to draw one leg to the chest to maintain the back flat while they will be in supine and to let the other thigh hang over the side of the bed. Ten reps of one set with 30 sec hold.

Primary outcome

1.

Visual analogue scale- To assess pain, a Visual Analogue Scale (VAS) will be utilised. The phrases “no pain” and “worst possible pain” are inscribed on a 10-cm-long, bidirectional straight line at each end of the line. Patients will be asked to mark their level of perceived pain on a scale by drawing a vertical line. Calculation and recording of the distance between the designated location and the left end point.

Reliability: r = 0.94, P = 0.001

Validity: 0.99. ¹⁷

1.

Muscle Strength-Pressure biofeedback unit

The Pressure Biofeedback Unit (PBU) consists of a catheter, a sphygmomanometer gauge, and a three-chamber air-filled pressure cell. The PBU's pressure cell is composed of latex-free rubber and measures 16.7 x 24.0 cm when unfurled. The range of the sphygmomanometer is 0 to 200 mmHg, and it will be calibrated at intervals of 2 mmHg. The pressure cells that are shown on the gauge experience volume fluctuations due to movement or changes in location. The pressure cell will first be inflated to a pressure of 40 mmHg before data collection (orange band). The valve will then shut, stopping the leak of air. The majority of scientific research concentrates on transversus abdominis assessment because of the PBU's function as a biofeedback device.

Procedure-The participant will be told to lie down in the hook position. the second sacral vertebra to the first lumbar vertebra, a pressure biofeedback cuff will be applied and inflated to 40 mmHg.

The participant will be given instructions on how to use the abdominal drawing-in manoeuvre (ADIM) to Without shifting their pelvis, gradually draw their navel in and maintain the appropriate pressure. ¹⁹

Sample size calculation: Sample size calculation resulted at 5% Z(1-α) value =1.96 & (1- β) at power of 80 %= 0.84 measuring the expected mean difference (effect size) of δ = 0.945 & standard deviation ( σ ) = 1.4

Sample size calculation Formula Using Mean difference n 1 = n 2 = 2 Z α + Z β 2 σ 2 δ 2

Primary Variable (Range of Motion)

Mean ± SD (Pre) result on Range of Motion for William flexion exercise (pre) = 6.3 ±1.4 As per reference

Clinically relevant superiority expected (post) Movement control exercises = 15 % = (6.3*15)/100 = 0.945

Difference = 0.945 (expected) N1 = 2 ∗ 1.96 + 0.84 2 1.4 2 / 0.945 2 = 34

Total samples required = 34 per Group.

Considering 10% drop out = 3

Total sample size required=37 per group

Notations: - Z α = 1.96 α = TypeI error at 5 % Z β = 0.84 1 − β = Powerat 80 % σ = std . dev

Referance Article: - The Modified – Modified Schober Test for range of motion assessment of lumbar flexion in patients with low back pain. Tousignant et al.

Total sample size = 74

All the results will be calculated using SPSS 27 version. Demographic variables (Confounding factors) as per quantative assessment will be resulted for finding observational values on mean Standard deviation minimum and maximum. Quantative assessment will be observed on frequency and percentage. The data for Inferential statistics, with outcome variables will be tested for normality using Kolmogorov Smirnov Test. Parametric test will be used if data follows normal distribution. Non normal data will be attempted for transformation to normality by using mathematical algorithm such as log or exponential function or box cox method. For finding the significance over the mean pre & post T-paired will be used for analysis if data still persist with non-normal distribution alternative Wilcoxon test will be used For finding the difference for mean significance between the two groups (Inter) un-paired t test will be used while e Man- Whitney will be used as an alternative t- test for non-normal data Association and Analysis for finding significance of confounding parameters will be evaluated using Chi square test or Fischer Exact Test or using multi-variant analysis.

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