Additional Effects of Pain Neuroscience Education With Standard Pre-operative Physiotherapy on Post-laminectomy Pain and Disability.
1 other identifier
interventional
44
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Feb 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 11, 2026
CompletedFirst Submitted
Initial submission to the registry
August 30, 2026
CompletedFirst Posted
Study publicly available on registry
September 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
September 3, 2026
August 1, 2026
11 months
August 30, 2026
August 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Neuropathic Pain
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
Neuropathic Pain
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
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.
3 weeks
Disability
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.
3 months
Study Arms (2)
Group 1(Standard pre-op physiotherapy+neuroscience education)
EXPERIMENTALGroup 2 (standard pre-op physiotherapy)
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Foundation University College of Physical Therapy
Islamabad, 44000, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2026
First Posted
September 3, 2026
Study Start
February 11, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
January 31, 2027
Last Updated
September 3, 2026
Record last verified: 2026-08