PNE With Therapeutic Exercises on Pain Intensity in Lumbar Radiculopathy

Lumbar Radiculopathy Clinical Trial

Official title:

Effects of Additional Pain Neuroscience Education (Pne) With Therapeutic Exercises on Pain Intensity in Patients With Lumbar Radiculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05356468
• Other study ID #: REC/01231 Hira hassan
• Status: Completed
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Pain
• Radiculopathy

Intervention

Other:
• Structured pain neuroscience education
Structured pain neuroscience Neurophysiology of pain The PNE occurred with the use of pictures, examples, metaphors and drawings as needed Metaphor Alarm system: Your nerves working like an alarm system to protect you. BOOKLET Consist of education about pain neurophysiology.(31) Steps of booklet : Extract content English to Urdu translation Content Validity Expert Panel review by Physiotherapists Content validity Analysis review(Focus Group) Pilot study 4 to 5 patients Content improved (PNE) and Finalized After Analysis RCT
• Conventional Treatment
ELECTROTHERAPY MODALTIES-15 min IFC (interferential current)IFC will be administered using following parameters: 80-150 watts, 4000 Hz, sweep on, 16.0-17.0 CV(26) Hot pack(27) Therapeutic exercises Strengthening (Back extensors, quadriceps, hamstring and VMO, gluteus maximums, gluteus medius, transverse abdominis. Stretching hamstring and, calf stretching. Soft tissue mobilization(5) McKenzie based exercises(28) BALANCE EXERCISES Single Leg Stance (static balance) Patient is instructed to stand on one leg,close his/her eyes and maintain this position as long as they could. Tandem gait (dynamic balance) patient is instructed to walk a total of 5 laps on a 2-meter-long line with the heel of the front foot touching the fingertip of the back foot.(29) POSTURAL TRAINING good posture when sitting standing and while driving Avoid weight lifting Avoid too much bed rest Sit in firm places. (30)

Locations

Country	Name	City	State
Pakistan	Misbah Ghous	Rawalpindi	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	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	Change From Baseline in Pain Scores on the Numeric Pain Rating Scale to 4 weeks till 8 Weeks
Primary	Time Up and Go Test(TUG)	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	Change From Baseline in balance Scores on the Time Up and Go Test(TUG) to 4 weeks till 8 Weeks.
Primary	Oswestry Disability Index	Change from Baseline , to 4Weeks, to 8 weeks	Change From Baseline in disability Scores on Oswestry Disability Index to 4 weeks till 8 Weeks.
Primary	Fear avoidance belief questionnaire	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	Change From Baseline in fear Scores on Fear avoidance belief questionnaire to 4 weeks till 8 weeks.
Primary	Beck Depression Inventory	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	Change From Baseline in depression Scores on Beck Depression Inventory to 4 weeks till 8 weeks
Primary	The Pittsburgh Sleep Quality Index	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	Change From Baseline in sleep quality Scores to 4 weeks till 8 weeks.