Comparison of two different exercise training programme on reducing pain and movement fear and to improve quality of life in patients with long term low back pain

Phase 3

Recruiting

• Conditions: Dorsopathy, unspecified,

• Registration Number: CTRI/2023/08/056228
• Lead Sponsor: KMCH Institute of Health Sciences and Research

Brief Summary

Non-speciï¬c low back pain is deï¬ned as low back pain (LBP) not attributable to a recognizable, known speciï¬c pathology (eg, infection, tumour, osteoporosis, lumbar spine fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome). Non-specific low back pain is usually categorized in 3 sub-types: acute, sub-acute and chronic low back pain. This sub-division is based on the duration of the back pain. Chronic low back pain lasts for 12 weeks or more. Most cases are non-specific, but in about 10% of cases a specific cause is identified. LBP has been found to have chronic widespread pain.

Non-specific low back pain accounts for more than 90% of episodes. It usually affects people aged 20–55 years. 80 % of the population is affected by this symptom at sometime in life. Impairments of back and spine are ranked as the most frequent cause of limitation of activity in people younger than 45 years. For 78 % men and 89 % women, specific cause was not known. It was believed that bad posture was responsible for most of these cases. All age groups can be affected by non-specific low back pain. But the impact on quality of life is lower in adolescents than in adults.  Low back pain is more common in heavy manual workers, particularly those in occupations that involve heavy lifting and twisting. Psychological factors (e.g. job dissatisfaction, depression, anxiety) are important risk factors for both acute back pain and the transition to chronic pain and disability.



Interventions of the study are Dynamic Neuromuscular Stabilization (DNS)  and Lumbar Stabilization Exercises (LSE) .



Dynamic Neuromuscular Stabilization (DNS) is an evolving concept in the field of rehabilitation. It is used successfully for the rehabilitation of various neurological, musculoskeletal, paediatric and sports injury cases. But only fewer studies have shown the effect of DNS on Low Back Pain.



Lumbar Stabilization Exercises (LSE) has become a popular treatment for low back pain. LSE are commonly used to improve lumbar stability and increase trunk muscle strength.



To date, no studies compares the combined effectiveness of dynamic neuromuscular stabilization along with lumbar stabilization exercise and lumbar stabilization exercise alone on pain, kinesiophobia and quality of life in patients with chronic non-specific low back pain.



Hence, the need for the study is to compare the combined the effectiveness of dynamic neuromuscular stabilization along with lumbar stabilization exercise and lumbar stabilization exercise alone  on pain, kinesiophobia and quality of life in patients with chronic non-specific low back pain.



The primary objective of the study is to evaluate the combined effectiveness of dynamic neuromuscular stabilization along with lumbar stabilization exercise and lumbar stabilization exercise alone on pain by using Numerical Pain Rating Scale (NPRS) in patients with Chronic non-specific low back pain among 2 groups.

Secondary objectives of the study is to evaluate the combined effectiveness of dynamic neuromuscular stabilization along with lumbar stabilization exercise and lumbar stabilization exercise alone on kinesiophobia and quality of life  by using Tampa Scale of Kinesiophobiasis (TSK – 11) and World Health Organization Quality of Life Scale (WHO QOL – BREF) in patients with Chronic non-specific low back pain among 2 groups.



60 patients with Chronic non-specific low back pain who fall under inclusion and exclusion criteria will be recruited from orthopedics and physiotherapy department through purposive sampling technique. Then the subjects will be  divided into two groups, group A (30) and group B (30) by lottery method. Group A will be receiving Dynamic neuromuscular  stabilization exercises along with lumbar stabilization exercises and Group B will be receiving Lumbar stabilization  Exercises alone. The demographic details of the participants will be collected and pre test evaluation of the following domains will be recorded by the principal investigator:

1. Pain by using Numerical Pain Rating Scale (NPRS)

2. Kinesiophobia by using Tampa Scale of Kinesiophobiasis (TSK – 11)

3. Quality of life by using  World Health Organization Quality of Life Scale (WHO QOL – BREF)



At the end of 4th week, the post test evaluation will be done to measure the variables.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-08
• Study Start: 2023-10-08

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1. Patients with Low back pain for more than 3 months. 2. Low back pain patients with the NPRS Score: 4-8 3. Patients with Low back pain without any other specific pathology confirmed by the Orthopaedician by clinical examination or CT scan or MRI scan. 4. Low back pain patients with the age group – 35 to 50 years. 5. Both male and female patients. 6. Stable medical condition to allow participation in the intervention and testing protocol. 7. Patients with the ability to understand and follow the therapist instructions. 8. Low back pain patients in the geographic area.
• Coimbatore city.

Exclusion Criteria

• Low Back Pain with specific pathology.
• (eg, infection, tumour, osteoporosis, lumbar spine fracture, structural or congenital deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome) 2.
• Patients with the history of recent spinal surgery or other surgeries which interrupts the exercise training or worsens the patient‘s condition.
• Pregnant women.
• Patients with Neurological problem or other musculo-skeletal conditions which interrupts the exercise training or worsens the patient‘s condition.
• Patients with metal implant.
• Patients with rheumatoid disorders.
• Patients with unstable cardiac conditions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain	Baseline- before commencing the treatment | Post test- at the end of 4th week of treatment

Secondary Outcome Measures

Name	Time	Method
Kinesiophobia
Quality of life	Baseline- before commencing the treatment

Trial Locations

Locations (1)

Kovai Medical Centre and Hospital (KMCH); 🇮🇳 Coimbatore, TAMIL NADU, India

Kovai Medical Centre and Hospital (KMCH)

🇮🇳Coimbatore, TAMIL NADU, India

Dr S Loka Janani

Principal investigator

9361399438

slokajananipt@gmail.com