PNE With Therapeutic Exercises on Pain Intensity in Lumbar Radiculopathy

NCT ID: NCT05356468

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2022-12-31

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.

Conditions

Lumbar Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Structured pain neuroscience education

Intervention Type: OTHER

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 :

1. Extract content

2. English to Urdu translation

3. Content Validity

4. Expert Panel review by Physiotherapists

5. Content validity Analysis review(Focus Group)

6. Pilot study 4 to 5 patients

7. Content improved (PNE) and Finalized

8. After Analysis RCT

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.

Group Type: ACTIVE_COMPARATOR

Conventional Treatment

Intervention Type: OTHER

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)

Interventions

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 :

1. Extract content

2. English to Urdu translation

3. Content Validity

4. Expert Panel review by Physiotherapists

5. Content validity Analysis review(Focus Group)

6. Pilot study 4 to 5 patients

7. Content improved (PNE) and Finalized

8. After Analysis RCT

Intervention Type: OTHER

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 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

Misbah Ghous, MSNMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah college of Rehabilitation and Allied Health sciences Islamabad

Locations

Misbah Ghous

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC/01231 Hira hassan

Identifier Type: -

Identifier Source: org_study_id