PNE With Therapeutic Exercises on Pain Intensity in Lumbar Radiculopathy
Primary Purpose
Lumbar Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Structured pain neuroscience education
Conventional Treatment
Sponsored by
About this trial
This is an interventional other trial for Lumbar Radiculopathy
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
Sites / Locations
- Misbah Ghous
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Structured pain neuroscience education
Conventional treatment
Arm Description
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 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.
Outcomes
Primary Outcome Measures
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
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
Oswestry Disability Index
Change from Baseline , to 4Weeks, to 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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05356468
First Posted
April 28, 2022
Last Updated
February 23, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05356468
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Structured pain neuroscience education
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Structured pain neuroscience education
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conventional Treatment
Intervention Description
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)
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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 Frame
Change From Baseline in Pain Scores on the Numeric Pain Rating Scale to 4 weeks till 8 Weeks
Title
Time Up and Go Test(TUG)
Description
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
Time Frame
Change From Baseline in balance Scores on the Time Up and Go Test(TUG) to 4 weeks till 8 Weeks.
Title
Oswestry Disability Index
Description
Change from Baseline , to 4Weeks, to 8 weeks
Time Frame
Change From Baseline in disability Scores on Oswestry Disability Index to 4 weeks till 8 Weeks.
Title
Fear avoidance belief questionnaire
Description
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
Time Frame
Change From Baseline in fear Scores on Fear avoidance belief questionnaire to 4 weeks till 8 weeks.
Title
Beck Depression Inventory
Description
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
Time Frame
Change From Baseline in depression Scores on Beck Depression Inventory to 4 weeks till 8 weeks
Title
The Pittsburgh Sleep Quality Index
Description
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
Time Frame
Change From Baseline in sleep quality Scores to 4 weeks till 8 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Misbah Ghous, MSNMPT
Organizational Affiliation
Riphah college of Rehabilitation and Allied Health sciences Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Misbah Ghous
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PNE With Therapeutic Exercises on Pain Intensity in Lumbar Radiculopathy
We'll reach out to this number within 24 hrs