Effects of Therapeutic Neuroscience Education in Patients With Chronic Low Back Pain

NCT ID: NCT05848076

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-08-01

Brief Summary

The study will be Randomized controlled trail, Subject diagnosed with low back pain meeting predetermined inclusion and exclusion criteria will be divided into two groups.

Pre assessment will be done using pain and disability as subjective measurement through Numeric pain rating scale (NPRS) & modified Oswestry disability index and the lumber range by goniometer as objective measurement. One group is subject will be treated with therapeutic neuroscience education and core stability exercise and second group is core stability exercise. Each subject received 18 sessions with 3 treatments per week. Post treatment values recorded after the session.After data collection from defined study setting,data will be entered and analyzed at Riphah International University,Lahore

Detailed Description

Chronic low back pain (LBP) is very common musculoskeletal disorders and leading causes of disability worldwide. Numerous epidemiological data show that 11%-84% of people experience, have experienced,or will experience pain in the lower spine at least once in their lives . With a global prevalence of 9.4%, LBP was ranked highest in the number of years lived with a disability and sixth in overall burden of disease Pakistan can suffer 56% from the LBP Nociplastic pain can be mechanistically defined as pain arising from the altered function of pain-related sensory pathways in the periphery and CNS, causing increased sensitivity Nociplastic pain should be viewed as an overarching terminology that can be applied to a diverse range of clinical conditions that share common neurophysiological mechanisms.

The main concern of TNE concept is that increasing the patient feeling of biology and physiology underpinning their pain condition instead of focus on anatomy and structure issues of tissue.In order to improve health of patient with CLBP healthcare provider proper educate their patient about experiencing pain and it may not result of tissue damage Several non surgical treatments have been offered to help and decrease LBP, such as joint manipulation, traditional therapeutic exercises , and medication

core stability training (CST) program this type of exercise focuses on the ability of the spine to stabilize in different positions and emphasize smaller, deeper, and posterior muscles. By increasing the endurance of these muscles, they retrain and maintain the correct physical condition to stabilize the spine to improve pain, performance, and ROM

There are few studies in literature which compare the TNE effect with core stability exercisein CLBP however there have been no studies which can compare TNE with nociplastic pain which effects on CLBP

Conditions

Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TNE with core stability

Group A (TNE WITH CORE STABILITY) on low back this McGill exercise focuses on the ability of the spine to stabilize in different positions 3 sets of 3 repletion with of each of muscle and briefly explain the patient about their pain.The study participants will receive the total 18 session over 6 weeks period consider 3 treatment session per week

Group Type: EXPERIMENTAL

TNE

Intervention Type: OTHER

McGill exercise focuses on the ability of the spine to stabilize in different positions 3 sets of 3 repletion with of each of muscle and briefly explains the patient about their pain

core stability

Intervention Type: OTHER

McGill exercises for the low back.

Core stability

McGill exercises for the low back. involved 3 sets of 3 repetitions for each muscle with a 30-second hold and 30-second rest interval for each repetition. The researcher will reassess the patient. Post treatment patient will complete Numeric Pain Rating Scale (NPRs), range of motion (Goniometer and Oswestry disability index (ODI). All study participant will receive a total of 18 treatment sessions over a six-week period, which consisted of 03 treatment sessions per week.

Group Type: ACTIVE_COMPARATOR

core stability

Intervention Type: OTHER

McGill exercises for the low back.

Interventions

TNE

McGill exercise focuses on the ability of the spine to stabilize in different positions 3 sets of 3 repletion with of each of muscle and briefly explains the patient about their pain

Intervention Type: OTHER

core stability

McGill exercises for the low back.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diffused chronic low back pain
• Stop movement due to fear of increasing pain
• Anxiety and sleep problem with CLBP
• Symptoms duration most of days in 6 months
• No treatment other than analgesics

Exclusion Criteria

• Diabetes mellites
• Radiating pain
• Spine surgery, fracture, arthritis

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Sanaullah, MS

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Ume Habiba

Role: PRINCIPAL_INVESTIGATOR

Study Principle Investigator

Locations

District Headquarter Hospital Layyah

Layyah, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC/RCR&AH/23/0105/ume Habiba

Identifier Type: -

Identifier Source: org_study_id