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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05848076
Other study ID # REC/RCR&AH/23/0105/ume Habiba
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date August 1, 2023

Study information

Verified date September 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date August 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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
core stability
McGill exercises for the low back.

Locations

Country Name City State
Pakistan District Headquarter Hospital Layyah Layyah Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric pain rating scale for pain NPRS (numeric pain rating scale) NPRS is based on 11 points numerical rating scale for determining pain intensity, 0( no
;pain), 10 (worst pain imaginable) pain intensity
3 weeks
Primary Modified Oswestry Disability index (Disability and function) Modified Oswestry Disability index Urdu version of Modified Oswestry Disability Index has become one of the principal condition-specific outcome measures used in the management of spinal disorders. At the baseline assessment, following each exercise session during the 12-week intervention, and finally at the end of the intervention programme, the MODI scores will be recorded 3 weeks
Secondary Goniometer (Range of Motion) A goniometer is an instrument that measures the available range of motion at a joint. The art and science of measuring the joint ranges in each plane of the joint are called goniometry. To measure the range of motion physical therapists most commonly use a goniometer. 3 weeks
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