Protocol summary

Study aim
The aim of the study is to assess how well pain, functional capacity, pain centralization and fear of movement may be improved by integrating pain neuroscience education with motor control exercises.
Design
In order to assess the benefits of bio-psychomotor rehabilitation that incorporates pain neuroscience education and motor control training to McKenzie treatments in patients having lumbar radiculopathy, this study carries out as a forward-looking, single-blind, equal groups randomized clinical experiment.
Settings and conduct
The study subjects will be evaluated at ABWA Hospital Khurrianwala, Prime Care Hospital, Fast Care Hospital and Faisal Hospital Faisalabad. This study is a single blinded study in which participants will be blinded and they will not be informed about their group allocation or which intervention is considered experimental or comparator.
Participants/Inclusion and exclusion criteria
Patients with age between 28-50 years, clinically diagnosed patients with lumbar radiculopathy and both males and females are included in this study. Participants who have a confirmed disc herniation between L4-S1 levels through MRI, have pain for at least 3 months and have a positive SLR between 40 and 70 degrees are included. Patients with fracture, trauma, inflammatory disorder, lumbar instability, scoliosis, patients with RA and other systemic diseases are excluded.
Intervention groups
Group A will receive Pain Neuroscience Education and Motor Control Training. Group B will receive McKenzie Therapy.
Main outcome variables
Numeric Pain Rating Scale to measure pain intensity Roland Morris Disability Questionnaire to measure disability Tampa Scale of Kinesiopjobia to measure fear of movement Michigan Body Map for centralization of symptoms.

General information

Reason for update
Acronym
RCT
IRCT registration information
IRCT registration number: IRCT20260810070604N1
Registration date: 2026-08-20, 1405/05/29
Registration timing: prospective

Last update: 2026-08-20, 1405/05/29
Update count: 0
Registration date
2026-08-20, 1405/05/29
Registrant information
Name
Lyba Musaddiq
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 322 6380789
Email address
lybamusaddiq@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-09-01, 1405/06/10
Expected recruitment end date
2026-11-30, 1405/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bio Psychomotor Rehabilitation Integrating Pain Neuroscience Education and Motor Control Training Versus McKenzie Therapy in Lumbar Radiculopathy
Public title
Integrated Pain Neuroscience Education and Motor Control Training Versus McKenzie Therapy in the Treatment of Lumbar Radiculopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 28-50 years Clinically diagnosed patients with lumbar radiculopathy Both males and females were included Participants who had a confirmed disc herniation between L4-S1 levels through MRI Had pain for at least 3 months Had positive SLR between 40 and 70 degrees
Exclusion criteria:
Fracture Trauma Inflammatory disorder Lumbar instability Scoliosis Patients with RA and other systemic diseases
Age
From 28 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly allocated individually into two groups (18 participants each) using computer-generated simple randomization. Group A receives PNE with Motor Control Training, while Group B receives McKenzie Theray. Allocation concealment is maintained using sequentially numbered, opaque, sealed envelopes opened after baseline assessment.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a single-blinded randomized clinical trial with two active intervention groups. Only the participants will be blinded to their group allocation and the study hypothesis. Both groups will receive physiotherapy interventions, with Group A receiving Motor Control Training with Pain Neuroscience Education and Group B receiving McKenzie Therapy. The physiotherapists and outcome assessor will not be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Parallel-group, single-blinded RCT with two active intervention groups, randomly allocated in a 1:1 ratio. Both groups will receive active physiotherapy interventions, with participants blinded to group allocation.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research and Ethics Committee (REC)
Street address
Riphah International University Faisalabad Campus, Main Satayana Road (Adjacent to Fish Farm), Faisalabad, Pakistan
City
Faisalabad
Postal code
38090
Approval date
2026-06-04, 1405/03/14
Ethics committee reference number
RCRAHS/DPT/S26/003

Health conditions studied

1

Description of health condition studied
Lumbar radiculopathy is a clinical condition caused by irritation, inflammation or compression of a nerve root in the lumbar spine. it commonly presents with low back pain radiation into buttock and lower extremity, along with symptoms such as numbness, tingling or muscle weakness. Disc herniation and degenerative changes of the lumbar spine are common causes.
ICD-10 code
M47.816
ICD-10 code description
Spondylosis without myelopathy or radiculopathy, lumbar region

Primary outcomes

1

Description
Intensity of pain experienced by patients with lumbar radiculopathy.
Timepoint
At baseline before intervention and immediately after completion of 10 treatment sessions over 2 weeks.
Method of measurement
Numeric Pain Rating Scale to measure pain intensity. NPRS is a 11-point, unidimensional tool (0-10) where o indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain and 7-10 indicates severe pain.

2

Description
Level of disability and functional limitation associated with lumbar radiculopathy.
Timepoint
At baseline before intervention and immediately after completion of 10 treatment sessions over 2 weeks.
Method of measurement
Roland Morris Disability Questionnaire (RMDQ) to measure level of disability and functional limitations where 0 indicates no disability, 1-8 indicates mild disability, 9-16 indicates moderate disability and 17-24 indicates severe disability.

3

Description
Fear of movement and hesitation associated with pain in patients with lumbar radiculopathy.
Timepoint
At baseline before intervention and immediately after completion of 10 treatment sessions over 2 weeks.
Method of measurement
Tampa Scale of Kinesiophobia to measure fear of movement and hesitation of movement. The TSK score ranges from 17-68, with lower scores indicating less fear of movement and higher scores indicating greater fear of movement.

4

Description
Pain distribution and location of pain in patients with lumbar radiculopathy.
Timepoint
At baseline before intervention and immediately after completion of 10 treatment sessions over 2 weeks.
Method of measurement
Michigan Body Map for distribution and location of pain and musculoskeletal symptoms across different body regions. The MBM assesses 35 body regions, with each symptomatic region receiving a score of 1 and each non-symptomation region receiving a score of 0. The total score ranges from 0-35 where a lower score indicating fewer symptomatic body regions while a higher score indicates symptoms in more body regions.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Group A will receive Pain Neuroscience Education and Motor Control Training (PNE+MCT). Patients will receive PNE and MCT for 2 weeks with five 30 to 40 minute session per week. PNE will be given for 10-15 minutes at the beginning of each session in order to lessen fear-avoidance beliefs and explain neurophysiology of pain. MCT, which concentrated on the activation as well as coordination of deep trunk muscle groups, like the transverse abdominus and multifidus will came next. Exercises will range from basic activation (breathing, drawing in the abdomen) to muscle control (heel slides. knee bent fallout) and functional exercises (bridging, bird-dog, sit-stand) within a pain-free range.
Category
Rehabilitation

2

Description
Intervention group 2: Group B will receive McKenzie Therapy for 2 weeks, with five sessions each week lasting 20 to 30 minutes each. Lumbar extension exercises, such as prone lying down, prone on elbows and prone press-ups will be the main emphasis of the intervention repeated motions and prolonged positions determined by directional preferance. McKenzie exercises will be performed for 10 repetitions per exercise, for 3 sets per session.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Fast Care Hospital Faisalabad
Full name of responsible person
Dr. Urwa Sehar
Street address
Fast Care Hospital Faisalabad, Rehman Garden gate 2 Fish Farm, Satayana Rd, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 336 7299066
Email
fchospital14@gmail.com
Web page address

2

Recruitment center
Name of recruitment center
Faisal Hospital
Full name of responsible person
Dr. Sarwat
Street address
Faisal Hospital 544-A, Peoples Colony, East Canal Road, near Abdullahpur in Faisalabad
City
Faisalabad
Postal code
38090
Phone
+92 41 8542214
Email
info@faisalhospital.com
Web page address

3

Recruitment center
Name of recruitment center
Prime Care Hospital Faisalabad
Full name of responsible person
Dr. Tabinda
Street address
Prime Care Hospital, Ahmad Street, off Susan Road (near Lasania Hotel). Saeed Colony. Madina Town, Faisalabad
City
Faisalabad
Postal code
38860
Phone
+92 41 2420515
Email
info@primecarehospitalfsd.com
Web page address

4

Recruitment center
Name of recruitment center
ABWA Hospital and Research Centre Khurrianwala
Full name of responsible person
Dr. Ana Awaid
Street address
ABWA Hospital and Research Centre , 1-km Khurrianwala-Jaranwala Road, Faisalabad, Pakistan
City
Faisalabad
Postal code
37630
Phone
+92 307 1112293
Email
info@abwahospital.pk
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University Faisalabad
Full name of responsible person
Dr. Lyba Musaddiq
Street address
Satyana Road, Faisalabad
City
Faisalabad
Postal code
38090
Phone
+92 322 6380789
Email
lyba.musaddiq@riphahfsd.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Academic Research
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Riphah International University Faisalabad
Full name of responsible person
Dr. Lyba Musaddiq
Position
Lecturer
Latest degree
Specialist
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Faisalabad Campus
City
Faisalabad
Province
Punjab
Postal code
38090
Phone
+92 322 6380789
Email
lyba.musaddiq@riphahfsd.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University Faisalabad
Full name of responsible person
Sehar Naz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Faisalabad, Main Satiana Road, adjacent to Fish Farm in Faisalabad, Pakistan
City
Faisalabad
Province
Punjab
Postal code
38090
Phone
+92 325 0677170
Email
seharnaz70rb@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University Faisalabad
Full name of responsible person
Izbah Azmat
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Faisalabad, Main Satiana Road, adjacent to Fish Farm in Faisalabad, Pakistan
City
Lahore
Province
Punjab
Postal code
38090
Phone
+92 324 4083470
Email
Izbah007@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The deidentified individual participant data will not be made publicly available due to participant privacy and confidentiality considerations. Data will be retained securely by the research team and used only for the purposes specified in the approved research protocol.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study Protocol and Statistical Analysis Plan for the study “Bio-Psychomotor Rehabilitation Integrating Pain Neuroscience Education and Motor Control Training versus McKenzie Therapy in Lumbar Radiculopathy” The documents will contain the study methodology, intervention procedures, outcome measures, and planned statistical analysis.
When the data will become available and for how long
The study protocol and statistical analysis plan will become available after completion of the study and publication of the study results. They will remain available thereafter for academic and research purposes.
To whom data/document is available
The documents will be available to researchers, healthcare professionals, students, and other individuals with a legitimate academic or research interest.
Under which criteria data/document could be used
The documents may be used for academic, educational, methodological, and research purposes. Requests will be reviewed by the research team to ensure that the intended use is appropriate and consistent with research and ethical requirements.
From where data/document is obtainable
The documents may be requested from the principal investigator or research team using the institutional contact information provided in the IRCT registration. Requests should be submitted through the official institutional email address.
What processes are involved for a request to access data/document
Interested individuals may submit a written request to the principal investigator or research team stating their name, affiliation, purpose of the request, and intended use of the document. The research team will review the request and provide access to eligible applicants within a reasonable period.
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