Lumbar RadiculopathyNCT05356468
PNE With Therapeutic Exercises on Pain Intensity in Lumbar Radiculopathy
A study testing Structured pain neuroscience education and Conventional Treatment in people with Lumbar Radiculopathy, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Structured pain neuroscience education and Conventional Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Apr 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Additional Pain Neuroscience Education (Pne) With Therapeutic Exercises on Pain Intensity in Patients With Lumbar Radiculopathy
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.
Read the 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
- Being tested
- Structured pain neuroscience education, Conventional Treatment
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured pain neuroscience educationOther
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 TreatmentOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change From Baseline in sleep quality Scores to 4 weeks till 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start15 Apr 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misbah Ghous, MSNMPT, Principal investigator, Riphah college of Rehabilitation and Allied Health sciences Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356468
- Sponsor's protocol ID
- REC/01231 Hira hassan
- Status last verified
- Feb 2023
- First submitted
- 28 Apr 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Additional Pain Neuroscience Education (Pne) With Therapeutic Exercises on Pain Intensity in Patients With Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT05356468
- Acronym / sponsor ID
- REC/01231 Hira hassan
- Conditions
- Lumbar Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured pain neuroscience education | Experimental | Other: Structured pain neuroscience educationPain neuroscience education will be given to both groups. Group A will receive Structured Pain Neuroscience Education along with therapeutic , balance exercises and Postural training. |
| Conventional treatment | Active comparator | Other: Conventional TreatmentGroup 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured pain neuroscience educationStructured 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 | Other | Structured pain neuroscience education |
| Conventional TreatmentELECTROTHERAPY 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) | Other | Conventional treatment |
Primary outcome
Numeric Pain Rating Scale
Time frame: Change From Baseline in Pain Scores on the Numeric Pain Rating Scale to 4 weeks till 8 Weeks
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)
Time frame: Change From Baseline in balance Scores on the Time Up and Go Test(TUG) to 4 weeks till 8 Weeks.
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
Time frame: Change From Baseline in disability Scores on Oswestry Disability Index to 4 weeks till 8 Weeks.
Change from Baseline , to 4Weeks, to 8 weeks
Fear avoidance belief questionnaire
Time frame: Change From Baseline in fear Scores on Fear avoidance belief questionnaire to 4 weeks till 8 weeks.
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
Time frame: Change From Baseline in depression Scores on Beck Depression Inventory to 4 weeks till 8 weeks
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
Time frame: Change From Baseline in sleep quality Scores to 4 weeks till 8 weeks.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Lumbar Radiculopathy
Active, not recruiting
Comparative Effects of Kinetic Control Training and Neural Mobilization in Lumbar Radiculopathy
Lumbar Radiculopathy
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Recruiting
Comparative Effect Between Mulligan Leg Raise and Spinal Mobilization With Limb Movement in Lumbar Radiculopathy
Lumbar Radiculopathy
Not yet recruiting
Comparison of Efficacy of Caudal Versus Transforaminal Epidural Steroid Injections in Unilateral S1 Nerve Root Pain: A Randomized Controlled Trial
Unilateral S1 Nerve Root Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Misbah Ghous, MSNMPT principal investigator
Riphah college of Rehabilitation and Allied Health sciences Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured pain neuroscience education and Conventional Treatment in people with Lumbar Radiculopathy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: Change From Baseline in Pain Scores on the Numeric Pain Rating Scale to 4 weeks till 8 Weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.