Additional Effects of Pain Neuroscience Education With Standard Pre-operative Physiotherapy on Post-laminectomy Pain and Disability.
This randomized controlled trial investigates whether adding Pain Neuroscience Education (PNE) to standard pre-operative physiotherapy improves outcomes after lumbar laminectomy. Chronic low back pain often involves central sensitization, where the nervous system continues amplifying pain signals even after the structural problem is surgically corrected, contributing to persistent neuropathic pain and disability after spine surgery.
The study will enroll 44 male and female patients aged 35-60 scheduled for elective one- or two-level lumbar laminectomy, with a pre-surgical waiting period of at least three weeks. Participants will be randomized into two equal groups. The experimental group will receive a three-week "nervous system priming" program: three 45-minute sessions combining PNE (explaining pain biology and neuroplasticity through culturally adapted metaphors) with standard exercises (ankle pumps, quad sets, gluteal sets, isometric abdominal sets, heel slides, and walking), plus a home program. The control group will receive identical standard exercises and session structure, but without PNE, using placebo counselling instead.
Outcomes will be measured using the painDETECT questionnaire (neuropathic pain) and the Oswestry Disability Index (functional disability), assessed at baseline, three weeks post-operatively, and three months post-operatively. The study will run for seven months following ethical approval.
The research addresses a gap in current perioperative care, which is typically reactive and rarely incorporates neurophysiological education into prehabilitation. If PNE proves effective, it could reduce post-laminectomy neuropathic pain and disability, decrease dependency on painkillers and prolonged rehabilitation, and inform more effective pre-surgical protocols for spine surgery patients.
Study Overview
Status
Conditions
Detailed Description
Background and Rationale
Lower back pain affects roughly 37% of the adult population, with 60-85% of people experiencing it at some point in their lives. Lumbar laminectomy and hemilaminectomy are the standard surgical treatments for spinal stenosis and disc herniation causing radiculopathy. However, even with technically successful decompression surgery, a substantial number of patients continue to experience neuropathic pain, chronic post-surgical pain, and ongoing disability - a pattern sometimes classified as Failed Back Surgery Syndrome.
A key driver of this persistent pain appears to be central sensitization: a state in which the nervous system becomes hypersensitive and continues amplifying pain signals even after the original tissue damage has been surgically addressed. In effect, the body's "alarm system" stays active long after the danger has passed, and fear-avoidance behaviors driven by this sensitization can further entrench chronic pain. Most current pre-operative care models are reactive and, where prehabilitation exists, it typically consists of generic exercise programs that do not address these underlying neurophysiological mechanisms.
Pain Neuroscience Education (PNE) is an evidence-based approach that helps patients understand that their pain reflects a sensitized nervous system rather than ongoing tissue damage. This understanding can reduce fear and catastrophizing and activate the brain's own pain-inhibiting pathways. While PNE has shown benefit when combined with exercise for chronic low back pain in several trials and meta-analyses, no standardized protocol currently integrates PNE into a cohesive pre-surgical (rather than purely conservative) program for laminectomy patients. This study is designed to fill that gap.
Significance
Because post-laminectomy neuropathic pain and disability remain common despite surgical advances, there is a clear need for improved pre-operative rehabilitation strategies. This study proposes and tests a "nervous system priming" program - one not currently part of standard pre-operative care - that pairs PNE with conventional pre-operative exercise. If shown effective, this approach could improve post-surgical recovery, reduce the prevalence of chronic pain, and lessen long-term reliance on analgesics and extended rehabilitation, while helping clinicians identify the more effective pre-operative approach for this patient population.
Objectives and Hypotheses
The study has two primary objectives: to compare the effects of PNE plus standard protocol versus standard protocol alone on post-laminectomy pain, and on post-laminectomy disability. The corresponding alternate hypotheses propose that there will be statistically significant differences (P<0.05) between groups in both post-operative neuropathic pain and disability; the null hypotheses propose no significant difference.
Study Design and Methods
This is a randomized controlled trial running over seven months. Forty-four patients aged 35-60 years, scheduled for elective, primary one- or two-level lumbar laminectomy or decompression for radiculopathy due to stenosis or herniation, with at least a three-week pre-surgical waiting period, will be recruited via surgeon referral using nonprobability purposive sampling. Sample size was calculated using G*Power at a 95% confidence interval with an estimated effect size of 0.25. Exclusion criteria include severe cognitive impairment, unstable medical conditions, spinal fractures, prior lumbar surgery, cauda equina syndrome, major systemic or psychiatric illness, and non-ambulatory status.
Participants will be randomized via coin toss into two groups of 22. The trial is single-blinded, with the control group receiving placebo counselling in place of actual PNE to preserve blinding. Both groups will undergo three individual 45-minute sessions over three weeks with a neuro-physical therapist, plus a home program. The experimental group's sessions combine two PNE sessions (covering pain biology, central sensitization, and neuroplasticity, delivered in Urdu using culturally adapted metaphors such as a "broken alarm" analogy, developed and pilot-tested for comprehension) with standard exercises. The control group receives the identical exercise protocol - ankle pumps, quad sets, gluteal sets, isometric abdominal sets, heel slides, and walking - without the educational component.
Outcome Measures
Neuropathic pain will be assessed using the painDETECT questionnaire (score ≥19 indicating a likely neuropathic component), and functional disability via the Oswestry Disability Index (a 10-point change considered clinically meaningful). The Central Sensitization Inventory will also be used. Assessments occur at baseline, three weeks post-operatively, and three months post-operatively to evaluate both short-term and sustained effects.
Ethical Considerations
The study will proceed only after informed consent from all participants and approval from the Institutional Review Board/Ethics Committee. Participant confidentiality will be maintained, participants retain the right to withdraw at any time, and the trial will be registered with a clinical trial registry and undergo CBRC registration.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Afifa Ittefaq, DPT
- Phone Number: +92-314-9797962
- Email: drafifaittefaq@gmail.com
Study Locations
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Islamabad, Pakistan, 44000
- Recruiting
- Foundation University College of Physical Therapy
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Contact:
- Muhammad Ehab Azim, PHD
- Phone Number: 642 051-5788171
- Email: ehab@fui.edu.pk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female patients
- Adults aged 35-60 years.
- Scheduled for elective, primary 1- or 2-level lumbar laminectomy/decompression for radiculopathy due to stenosis or herniation.
- A pre-surgical waiting period of at least 3 weeks.
- Able to understand and provide informed consent in Urdu/English.
Exclusion Criteria:
- Severe cognitive impairment
- Unstable medical conditions
- Lower limb or spinal fractures or severe joint deformities
- Previous lumbar spine surgery.
- Cauda equina syndrome or other surgical emergencies.
- Major systemic illness (e.g., uncontrolled cardiovascular disease, cancer) or psychiatric disorder that would limit participation.
- Non-ambulatory status prior to surgery
- Significant Neural deficit after surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group 1(Standard pre-op physiotherapy+neuroscience education)
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This group receives a 3-week pre-surgical program of three individual 45-minute sessions with a neuro-physical therapist, plus a daily home program.
It combines Pain Neuroscience Education (PNE), delivered in Urdu using culturally adapted metaphors (e.g., the "broken alarm" analogy for central sensitization) developed through expert panel review, with standard exercises.
Each session includes 15-20 minutes of education, 20-25 minutes of exercise (ankle pumps, quad sets, gluteal sets, isometric abdominal sets, heel slides, walking), and 5 minutes of home practice.
PNE aims to reframe pain as nervous-system sensitization rather than ongoing tissue damage, reducing fear-avoidance before surgery.
|
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Active Comparator: Group 2 (standard pre-op physiotherapy)
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This group follows the identical 3-week format-three individual 45-minute sessions with a neuro-physical therapist plus a prescribed daily home program-but without Pain Neuroscience Education.
Instead, participants receive placebo counselling and an explained consent form in place of actual pain education, maintaining single-blinding.
The exercise protocol matches the experimental group exactly: ankle pumps (10 reps), quad sets (hold 5 counts, 10 reps), gluteal sets (hold 5 counts, 10 reps), isometric abdominal sets (hold 5 counts, 10 reps), heel slides (10 reps, 3x/day), and walking (10 minutes, 3x/day).
This group serves as the comparator to isolate the added effect of PNE.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuropathic Pain
Time Frame: 3 weeks
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Neuropathic pain will be assessed using the pain DETECT Questionnaire, a 9-item screening tool with 85% specificity for identifying neuropathic pain components.
Scores below 12 indicate the neuropathic component is unlikely, 13-18 suggest it's possible, and 19 or higher indicates it is highly likely present.
Assessments will occur at baseline, 3 weeks post-operatively, and again at 3 months to track sustained effects.
|
3 weeks
|
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Neuropathic Pain
Time Frame: 3 months
|
Neuropathic pain will be assessed using the pain DETECT Questionnaire, a 9-item screening tool with 85% specificity for identifying neuropathic pain components.
Scores below 12 indicate the neuropathic component is unlikely, 13-18 suggest it's possible, and 19 or higher indicates it is highly likely present.
Assessments will occur at baseline, 3 weeks post-operatively, and again at 3 months to track sustained effects.
|
3 months
|
|
Disability
Time Frame: 3 weeks
|
Functional disability will be measured using the Oswestry Disability Index (ODI), a 10-item questionnaire with excellent reliability (ICC >0.90) and validity.
Each section scores 0-5, with total percentage scores interpreted as: 0-20% minimal disability, 21-40% moderate, 41-60% severe, 61-80% crippled, and 81-100% bed-bound.
A change of 10 points or more is considered the minimally clinically important difference (MCID).
ODI will also be assessed at baseline, 3 weeks post-operatively, and 3 months post-operatively.
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3 weeks
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Disability
Time Frame: 3 months
|
Functional disability will be measured using the Oswestry Disability Index (ODI), a 10-item questionnaire with excellent reliability (ICC >0.90) and validity.
Each section scores 0-5, with total percentage scores interpreted as: 0-20% minimal disability, 21-40% moderate, 41-60% severe, 61-80% crippled, and 81-100% bed-bound.
A change of 10 points or more is considered the minimally clinically important difference (MCID).
ODI will also be assessed at baseline, 3 weeks post-operatively, and 3 months post-operatively.
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3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/FUCP/CTR/Neuro/Afifa
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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