PNE With Therapeutic Exercises on Pain Intensity in Lumbar Radiculopathy

Not Applicable

Completed

• Conditions: Lumbar Radiculopathy
• Interventions: Other: Conventional Treatment; Other: Structured pain neuroscience education

• Registration Number: NCT05356468
• Lead Sponsor: Riphah International University

Brief Summary

There is lack of structured pain neuroscience education in patients with lumber radiculopathy. Previously researches were done on pain neuroscience education before surgery of lumber radiculopathy. However this study will provide structured educational plan about pain neuroscience education along with therapeutic exercises to positively influence pain knowledge, dysfunction, and fear avoidance, limitation in movement and healthcare utilization in patients who have diagnosed with lumbar radiculopathy and don't want to undergo surgery.

Detailed Description

Radicular pain or radiculopathy, defined as spinal nerve root dysfunction causing dermatomal discomfort and paresthesia's, myotome weakness, and/or reduced deep tendon reflexes, is frequently associated with axial spine pain. It affects both men and women and is believed to impact 3 to 5 percent of the population. Radiculopathy is pain that radiates down the legs and is described as electric, burning, and acute pain. Radiculopathy is most caused by irritation of a specific nerve, which can occur anywhere along the nerve and is most often caused by a compressive force. It could be caused by bulging or herniated discs, facet or ligamentous hypertrophy, spondylolisthesis, or even neoplastic or infectious diseases.

LR is the second leading cause of disability according to a research published by Global Burden of Disease (GBD).Pain neuroscience education (PNE), also known as therapeutic neuroscience education (TNE), is a series of instructional sessions for patients that cover the neurobiology and neurophysiology of pain, as well as how the nervous system processes pain. PNE alters the way a patient perceives pain at first. For example, a patient may have assumed that damaged tissues were the source of their pain; yet, after learning more about pain neurophysiology, the patient realises that pain may not accurately reflect tissue health and instead be caused by extra-sensitive nerves.

Study Timeline

• Study Start: 2022-04-15
• Study First Submitted: 2022-04-28
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-02
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Presence of lumbar radiculopathy ( disc bulge , disc herniation , lumbar stenosis, disk dehydration(13)
• Medication. (Patient already on prescriptions, using medicines)
• Duration of low back pain as the main symptom for at least 3 months

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Exclusion Criteria

• The presence of chronic-pain-related conditions (e.g. fibromyalgia, chronic fatigue syndrome.)
• Pregnancy
• Patients on treatment with alternative therapies.
• Patients with associated pathologies that make it impossible to perform a physical exercise program (myopathies, neurological diseases with significant impairment of functionality

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional treatment	Conventional Treatment	Group B will receive Pain Neuroscience Education along with therapeutic, balance exercises. The treatment will continue for 6 weeks. Three sessions will be given in a week. Assessment would be done on baseline and at the end of every third week. Each session will be of 45 minutes. 15min electrotherapy, 15 min conventional treatment, 15 min PNE education.
Structured pain neuroscience education	Structured pain neuroscience education	Pain neuroscience education will be given to both groups. Group A will receive Structured Pain Neuroscience Education along with therapeutic , balance exercises and Postural training.

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale	Change From Baseline in Pain Scores on the Numeric Pain Rating Scale to 4 weeks till 8 Weeks	The NPRS is used to measure pain intensity, in which patients are asked to select a number (from 0-10) to represent their pain severity.Change from Baseline , to 4Weeks, till 8 weeks
Time Up and Go Test(TUG)	Change From Baseline in balance Scores on the Time Up and Go Test(TUG) to 4 weeks till 8 Weeks.	Timed up and go test (TUG) was used for measuring the time needed by the participants to stand up from the chair, walk 3 m to a red marker, and return to the starting position on the chair. Change from Baseline , balance and fall prevention to 4Weeks, 8 weeks
Oswestry Disability Index	Change From Baseline in disability Scores on Oswestry Disability Index to 4 weeks till 8 Weeks.	Change from Baseline , to 4Weeks, to 8 weeks
Fear avoidance belief questionnaire	Change From Baseline in fear Scores on Fear avoidance belief questionnaire to 4 weeks till 8 weeks.	Fear avoidance belief questionnaire he FABQ comprises two subscales; one measures the potential influence of fear-avoidance beliefs on general physical activity Change from Baseline , to 4Weeks, to 8 weeks
Beck Depression Inventory	Change From Baseline in depression Scores on Beck Depression Inventory to 4 weeks till 8 weeks	Beck Depression Inventory (BDI) is a 21-item self-reporting questionnaire for evaluating the severity of depression in normal and psychiatric populations. Change from Baseline , to 4Weeks, to 8 weeks
The Pittsburgh Sleep Quality Index	Change From Baseline in sleep quality Scores to 4 weeks till 8 weeks.	The PSQI is a self-rating questionnaire resulting in a global score between 0 and 21 which consist of seven sub scores. Change from Baseline , to 4Weeks, to 8 weeks

Trial Locations

Locations (1)

Misbah Ghous; 🇵🇰 Rawalpindi, Punjab, Pakistan