This study aimed to verify the effects of PNE pain neuroscience education compared with the physical exercises techniques in patients with lumbar radiculopathy.
Design
The goal of PNE to re-conceptualizing pain observation from a biological or structural model to a bio psychosocial pain perception.
Settings and conduct
conduct; Allied Hospital Faisalabad, Aziz Fatima Hospital Faisalabad , Madina Teaching Hospital Faisalabad
Participants/Inclusion and exclusion criteria
34 participants were enrolled, non probability convenience sampling technique was used. Patients divided into 2 groups interventional group and control group. Inclusion criteria: both genders male and female , Age group (40-60) , Lumbar pain which radiates down to leg or radiating below the knee, Diagnosed patients with lumbar radiculopathy , As a minimum Pain score 3/10 on VAS, The following radicular signs:1 Any dermatome between L4 and S1 that is numbness paresthesia, 2 Loss of muscle strengthen any of the L4-S1 myotomes Exclusion Criteria: Spine fracture, Pregnancy, Cauda equine syndrome , Oncological pain ,History of pelvis, hip or spine surgical intervention in the last year, Unimpaired cognition / intelligence (Mini Mental State Examination Score of >24)
Intervention groups
In experimental group patients was performed a PNE approach which consists in six sessions 2 time per week, for about 60 minutes with therapeutic physical exercise performed session; 3 sessions per week. Session was completed in 35-45 minutes then cool down phase including with relaxation exercises for 10-15 minutes.
Main outcome variables
Pain intensity and Functional disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230614058479N1
Registration date:2023-09-23, 1402/07/01
Registration timing:retrospective
Last update:2023-09-23, 1402/07/01
Update count:0
Registration date
2023-09-23, 1402/07/01
Registrant information
Name
Mahzaib Khalid
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8750971
Email address
2021-ms-pt-050@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-24, 1402/02/04
Expected recruitment end date
2023-06-26, 1402/04/05
Actual recruitment start date
2023-04-24, 1402/02/04
Actual recruitment end date
2023-06-26, 1402/04/05
Trial completion date
2023-06-26, 1402/04/05
Scientific title
Effect of pain neuroscience education and physical exercise for patients with lumbar radiculopathy
Public title
Effect of pain neuroscience education PNE and physical exercise for patients with lumbar radiculopathy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
• Patients of both genders male and female
• Age group (40-60)
• Lumbar pain which radiates down to leg or radiating below the knee
• Diagnosed patients with lumbar radiculopathy
• As a minimum Pain score 3/10 on VAS
• The following radicular signs: 1. Any dermatome between L4 and S1 that is numbness paresthesia 2. Loss of muscle strengthen any of the L4-S1 myotomes
Exclusion criteria:
• Spine fracture
• Pregnancy
• Cauda equine syndrome
• Oncological pain
• History of pelvis, hip or spine surgical intervention in the last year
• Unimpaired cognition / intelligence (Mini Mental State Examination Score of >24)
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
34
Actual sample size reached:
34
Randomization (investigator's opinion)
Randomized
Randomization description
the non probability convenience sampling technique.(random allocation by computer generative Lottery method), Patients divided into two groups one is interventional group while other is control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
participants are blinded during the trial
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Review Commitee
Street address
University Avenue, Faisal Town Canal Road
City
Faisalabad
Postal code
38000
Approval date
2023-08-09, 1402/05/18
Ethics committee reference number
TUF/DR/SA/MSPP/2023/246
Health conditions studied
1
Description of health condition studied
Lumbar Radiculopathy
ICD-10 code
M54.16
ICD-10 code description
Radiculopathy, lumbar region
Primary outcomes
1
Description
pain
Timepoint
1, 3, 6 week
Method of measurement
Pain intensity: Visual Analogue scale for screening of patients and outcomes measured by Roland Morris low back pain and disability questionnaire,The back pain functional scale , Fear-Avoidance belief questionnaire.
Secondary outcomes
1
Description
Functional Disability
Timepoint
1, 3 ,6 week
Method of measurement
Pain intensity: Visual Analogue scale for screening of patients and outcomes measured by Roland Morris low back pain and disability questionnaire, The back pain functional scale , Fear-Avoidance belief questionnaire
Intervention groups
1
Description
Intervention group: this group patients was performed a PNE approach which consists in six sessions 2 time per week, for about 60 minutes with therapeutic physical exercise (PE) performed session; 3 sessions per week which are consisting on Warm-up, slow and deep breathing exercise for about 3 minutes to relax the patient, then activation and join mobility exercises, balance and agility exercises, strength exercises and resistance training (in includes ankle pump, heel slide, Straight leg raise, Bridging and modified bridging with leg raise, 4 point kneeling, and kneeling with arm and leg lift) hold all positions for 5 to 10 seconds with 10 repetitions starts moderate exercises that was gradually increased. Each exercises session was completed in 35-45 minutes and then cool down phase including with relaxation exercises for 10-15 minutes.
Category
Rehabilitation
2
Description
Intervention group: this group patients was performed a PNE approach which consists in six sessions 2 time per week, for about 60 minutes with therapeutic physical exercise (PE) performed session; 3 sessions per week which are consisting on Warm-up, slow and deep breathing exercise for about 3 minutes to relax the patient, then activation and join mobility exercises, balance and agility exercises, strength exercises and resistance training (in includes ankle pump, heel slide, Straight leg raise, Bridging and modified bridging with leg raise, 4 point kneeling, and kneeling with arm and leg lift) hold all positions for 5 to 10 seconds with 10 repetitions starts moderate exercises that was gradually increased. Each exercises session was completed in 35-45 minutes and then cool down phase including with relaxation exercises for 10-15 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Allied Hospital
Full name of responsible person
Dr. Sobia Nawaz
Street address
Jail Road, adjacent Faisalabad Medical University, Near Sargodha Road, Faisalabad
City
Faisalabad
Postal code
37000
Phone
+92 41 9210082
Email
info@pmc.edu.pk
Web page address
http://www.pmc.edu.pk
2
Recruitment center
Name of recruitment center
Aziz Fatima Hospital
Full name of responsible person
Dr. Basit Mehmood
Street address
Raja Road Gulistan Colony 1, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 8780910
Email
hr@afh.com.pk
Web page address
http://afh.com.pk
3
Recruitment center
Name of recruitment center
Madina Teaching Hospital
Full name of responsible person
Dr. Kishwar
Street address
Sargodha Road, University Town, Faislabad
City
Faisalabad
Postal code
37251
Phone
+92 41 8869861
Email
info@mth.org.pk
Web page address
https://mth.org.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The university of Faisalabad
Full name of responsible person
Mahzaib Khalid
Street address
University Avenue, Faisal Town Canal Road Faisalabad
City
Faisalabad
Postal code
37000
Phone
+92 305 7666514
Email
mahzaib01@gmail.com
Grant name
No
Grant code / Reference number
No
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self Funded
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
The university of Faisalabad
Full name of responsible person
Mahzaib Khalid
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 9, L Block, Wapda city, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
37000
Phone
+92 305 7666514
Email
mahzaib01@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The university of Faisalabad
Full name of responsible person
Mahzaib Khalid
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
University Avenue, Faisal Town Canal Road Faisalabad
City
Faisalabad
Province
Punjab
Postal code
37000
Phone
+92 305 7666514
Email
mahzaib01@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The university of Faisalabad
Full name of responsible person
Asma
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
709-B people's colony no.1
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 321 7607141
Email
baigasma96@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
EFFECT OF PAIN NEUROSCIENC EDUCATION AND PHYSICAL EXERCISE FOR PATIENTS WITH LUMBAR RADICULOPATHY: A RONDAMISED CLINICAL TRAIL
When the data will become available and for how long
Data will be available for other people almost 6 months after the completion of study
To whom data/document is available
Data will be available for other people almost 6 months after the completion of study
Under which criteria data/document could be used
The data/ document could be used by communicating with the principle investigator Mahzaib Khalid gmail: mahzaib01@gmail.com
From where data/document is obtainable
Mahzaib Khalid gmail: mahzaib01@gmail.com
What processes are involved for a request to access data/document
The data/ document could be used by communicating with the principle investigator Mahzaib Khalid gmail: mahzaib01@gmail.com