PNE With Therapeutic Exercises on Pain Intensity in Lumbar Radiculopathy

NCT05356468 | Completed DMC

• 1 other identifier: REC/01231 Hira hassan
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Radiculopathy

Outcome Measures

Primary Outcomes (6)

• 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

• 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.

• 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.

• 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.

• 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

• 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.

Study Arms (2)

Structured pain neuroscience education

EXPERIMENTAL

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.

Other: Structured pain neuroscience education

Conventional treatment

ACTIVE COMPARATOR

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.

Other: Conventional Treatment

Interventions

Structured pain neuroscience education 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

Structured pain neuroscience education

Conventional Treatment 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)

Conventional treatment

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Misbah Ghous

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Misbah Ghous, MSNMPT

  Riphah college of Rehabilitation and Allied Health sciences Islamabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 2, 2022
• Study Start: April 15, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)