Effect of graded motor control exercise program on patients with non-specific low back pa in- A Randomized controlled trial

Recruiting

Conditions: Unspecified soft tissue disorder related to use, overuse and pressure,

Registration Number: CTRI/2022/04/041705

Lead Sponsor: Dr APJ Abdul Kalam College Of Physiotherapy

Brief Summary: The global burden of disease ranked low back pain as top clinical condition with disability and ranked sixth under disability adjusted life years. It is a common complaint with 70% to 85% life time prevalence and an average prevalence of 30%2. The annual worldwide incidence of low back pain (LBP) in adults is estimated to be approximately 5- 30% and at least 50-80 % of adults will experience LBP at some point in their life 1 .Recurrence of low back pain is also very high , 50% within one year , 60% within two years and 70% within five years20. Older adults, aged 65 years or above, are the second most common age group to visit physicians for LBP. Females are more susceptible to chronic LBP than males regardless of age. Jimenez-Sanchez and coworkers estimated that women were two times more likely to develop chronic LBP than men. A Spanish study found that the prevalence rates of chronic LBP among females and males aged 65 years or older were 24.2 and 12.3%, respectively.2 Low back pain not attributable to a structural change, inflammation and specific disease is defined as non-specific low back pain. One of the suggested mechanisms for NSLBP is the lack of stability of the spine. It was postulated that impairments in the control of the deep trunk muscles (transverses abdominis and multifidus) may lead to lack of coordination and stability of the spine1.

There are 2 types of risk factors of low back pain that are modifiable and non-modifiable risk factors: While occupational exposures to whole-body vibrations, lifting, bending, twisting, stooping, have been identified as potential risk factors for LBP in the working-age group, increasing evidence suggests that previous occupational exposure to physically strenuous work increases the risks of LBP in retired seniors.3

Modifiable risk factors include:

Â·       Psychological distress

Â·       Moderate or vigorous physical activity

Â·       Inactivity

Â·       Smoking

Â·       Social environment

Â·       Self-perceived health

Â·       Co-morbidity

Â·       Falls

Non-modifiable risk factors include:

Â·       Age related change in central pain processing

Â·       Dementia (incapable to express pain)

Â·       Gender

Â·       Genetics

Â·       Prior work exposure

Â·       Low income

Â·       Low education

Â·       Marital status

Nonspecific LBP is characterized by the absence of structural change; that is, there is no disc space reduction, nerve root compression, bone or joint injuries, marked scoliosis or lordosis that may lead to back pain. Only 10% of LBP has a specific cause due to a particular disease3. the lack of structural change in nonspecific LBP, it can limit daily activities and cause temporary or permanent inability to work, being one of the main causes of absence at work in the Western world 2. The incidence of nonspecific LBP is higher in workers subjected to heavy physical exertion, such as weight lifting, repetitive movements, and frequent static posture5. The characteristics of nonspecific LPB are heavy pain, worsening with exertion especially in the afternoon, relieved with rest, absence of neurological and muscle contraction, and antalgic posture, associated with inactivity and poor posture2. LBP is classified in a variety of ways. One classification method is based on the following three categories: acute, subacute and chronic LBP. Acute LBP is defined as pain lasting less than 6 weeks, subacute LBP is from six to twelve weeks, and chronic LBP persists for greater than 12 weeks . Another classification method involves categorizing LBP as non-specific (lacking a distinct attributable cause), and specific LBP (that can be traced to a specific pathology or condition).

Management of LBP must be patient- centered considering the patients experience and the impact of their pain ( physical, psychological, social, and professional aspects). LBP Management consist of drug therapy, surgical , non -invasive therapy, physical therapy , psychological therapy . With chronic low back pain it is useful to consider a multidisciplinary approach which involves a physiotherapist, rheumatologist, a physical medicine and a rehabilitation physician, an occupational physician , a spine surgeon. Drug treatment includes use of paracetamol, Opioids , Non- steroidal anti-inflammatory drugs.

Non- drug treatment first the medical diagnosis of common LBP must be made , in this the physical activity is a main treatment for a favorable evolution of LBP.

1st line treatment includes:

A self-management and return to daily activities ( including early return to work if possible), Adapted physical activities or sports activity should be started (According to patient preference), Physiotherapy management ex: use of therapeutic exercises. The physiotherapist participates in patientsâ€™ education ( reassurance, fight against fear and beliefs , awareness of physical activity benefits ) as a part of bio-psychosocial management. Active participation of patient is needed.

2nd line treatment includes:

Manual techniques ( manipulation , mobilization) only as a part of multimodal combination of treatment including a supervised exercise programme. A psychological intervention such as cognitive behavioral therapy conducted by a cognitive behavioral therapist professional.

Motor control is defined as the ability of the nervous system to control posture and movement for a given motor task and encompasses all the motor, sensory and integrative processes associated with the planning and execution of the task1. motor control exercise (MCE) is commonly used for the management of nonspecific low back pain (LBP). This form of exercise was developed on the basis of the concept that individuals with LBP present with changes in the control and coordination of the spine muscles13. MCE focuses on the activation of the deep spine muscles (i.e., transversus abdominis and multifidus), targeting the restoration of control and coordination of these muscles. During the intervention, patients are taught how to isolate the deep spinal muscles while maintaining normal respiration. The advanced stage of the intervention includes the progression toward more complex and functional tasks integrating the activation of deep and global trunk muscles11.

Movement Control Impairment (MCI) is defined as limited active movement in the lumbar spine on performing functional tasks. CLBP patients tend to have reduced movement control or control impairment which provokes pain . Various researches hypothesized movement control deficits fall under a large subgroup of LBP and can benefit from specific exercises.

NEED OF STUDY:Current literature has shown that Low back pain is one of the most common problems across the globe with prevalence of 5-30% and affects the work performances, functional status and Quality of life of individuals if persistent. Good postural habits , core control, flexibility are some of the important components in prevention of risk of low back pain and its pathologies. Current literature has shown that Motor control exercises has shown effect on core muscle control, which plays major role in improving core stability and further preventing the risk of low back pain hence, there is a need to design optimum graded motor control exercise program for improvement of core function and prevention of risk of Low back pain.

**RESEARCH QUESTION**

Is there any effect of graded motor control exercise program on pain, disability and quality of life on patients with non-specific Low back pain?

**Hypotheses**

**Null Hypothesis (H0):**

There will not be significant effect of graded motor control exercise program on pain, disability and quality of life on patients with non-specific Low back pain.

**Alternative Hypothesis (H1):**

There will besignificant effect of graded motor control exercise program on pain, disability and quality of life on patients with non-specific Low back pain.

**AIM AND OBJECTIVES:**

**AIM:**

To find the effect of graded motor control exercise program on pain, disability and quality of life in patients with non-specific low back pain.

**OBJECTIVES:**

1.     To find the effect of graded motor control exercise program on pain and disability in patients with non-specific low back pain- Oswestry pain and disability Questionnaire.

2.     To find the effect of graded motor control exercise program on Quality of life in patients with non- specific low back pain- SF- 20 Questionnaire.

**AIM AND OBJECTIVES:**

**AIM:**

To find the effect of graded motor control exercise program on pain, disability and quality of life in patients with non-specific low back pain.

**OBJECTIVES:**

1.     To find the effect of graded motor control exercise program on pain and disability in patients with non-specific low back pain- Oswestry pain and disability Questionnaire.

2.     To find the effect of graded motor control exercise program on Quality of life in patients with non- specific low back pain- SF- 20 Questionnaire.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 66

Inclusion Criteria

1.Participants who are pre-diagnosed with non- specific low back pain 2.Aged between 18 to 40 years 3.Males and females 4.Had bilateral and unilateral low back pain 5.Non-specific low back pain without any underlying pathologies 6.Pain rating 4- 6 on NPRS scale.

Exclusion Criteria

Participants who are not willing to participate in study 2.Any recent surgical history of spine and abdomen 3.Any systemic illness , rheumatic conditions, inflammatory joint disease, tumor, and unhealed fracture and any other spine pathologies) 4.Pregnancy 5.Psychologically unstable patients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. pain with numerical pain rating scale	baseline- 4th week- 8th week
2. disability with oswestry pain and disability questionnaire	baseline- 4th week- 8th week
3. Quality of life of patients with SF-12	baseline- 4th week- 8th week

Secondary Outcome Measures

Name	Time	Method
1.Improvement in functional abilities in patients	2.Fear of Exercise/movement in patient ( kinesiophobia)

Trial Locations

Locations (1): Pravara Rural hospital
🇮🇳
Ahmadnagar, MAHARASHTRA, India
Pravara Rural hospital
🇮🇳Ahmadnagar, MAHARASHTRA, India
Vaibhavi kulkarni
Principal investigator
9637413928
vaibhavi.kulkarni264@gmail.com