Clinical trial NCT05356468: PNE With Therapeutic Exercises on Pain Intensity in Lumbar Radiculopathy
Official title: Effects of Additional Pain Neuroscience Education (Pne) With Therapeutic Exercises on Pain Intensity in Patients With Lumbar Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Radiculopathy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Change From Baseline in Pain Scores on the Numeric Pain Rating Scale to 4 weeks till 8 Weeks
measure: Time Up and Go Test(TUG)
timeFrame: Change From Baseline in balance Scores on the Time Up and Go Test(TUG) to 4 weeks till 8 Weeks.
measure: Oswestry Disability Index
timeFrame: Change From Baseline in disability Scores on Oswestry Disability Index to 4 weeks till 8 Weeks.
measure: Fear avoidance belief questionnaire
timeFrame: Change From Baseline in fear Scores on Fear avoidance belief questionnaire to 4 weeks till 8 weeks.
measure: Beck Depression Inventory
timeFrame: Change From Baseline in depression Scores on Beck Depression Inventory to 4 weeks till 8 weeks
measure: The Pittsburgh Sleep Quality Index
timeFrame: Change From Baseline in sleep quality Scores to 4 weeks till 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Misbah Ghous
state: Punjab
Study officials:
affiliation: Riphah college of Rehabilitation and Allied Health sciences Islamabad
name: Misbah Ghous, MSNMPT
role: PRINCIPAL_INVESTIGATOR
References: