The objective of this study is to investigate the effectiveness of Proprioceptive paradigm in addition to strength training program on pain, functional disability, and cervical proprioception in the treatment of Cervical Radiculopathy patients.
Design
Parallel group Randomised Control trial with double blinded study.
Settings and conduct
Physical Therapy Department of Allama Iqbal Teaching Hospital D. G. Khan, Outpatient Clinics.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age between 30-55 years. Both male and females are included. Patients with pain or numbness of one or both arms. Duration of symptoms is from more than 3 months. Exclusion Criteria: Past fracture or surgery in cervical spine. Deformity of the spine. Inflammatory rheumatologic disease.
Intervention groups
Group A (Experimental group) patients were received proprioception training paradigm (eye head coupling based rehabilitation program) described by Revel M in the cervical region along with myofascial release or soft tissue release for 20 minutes as well as a strength training program for 10 minutes and patients in group B (Control group) were received only the same specific strength training program for 30 minutes.
Main outcome variables
1. Pain
2. Functional Disability
3. Cervical Proprioception (ROM)
Treatment outcomes such as pain, disability and proprioception were determined from the following scales: scores of Neck Pain from VAS and Scores for functional disability from Neck Disability Index (NDI) as a self-reported measure while for Proprioception Head Position Accuracy, a laser beam device/ Laser Pointer device (LPD) was used
General information
Reason for update
Acronym
PP
IRCT registration information
IRCT registration number:IRCT20240513061777N1
Registration date:2024-08-02, 1403/05/12
Registration timing:retrospective
Last update:2024-08-02, 1403/05/12
Update count:0
Registration date
2024-08-02, 1403/05/12
Registrant information
Name
Ufaq Hafeez
Name of organization / entity
University of lahore
Country
Pakistan
Phone
+92 61 4552420
Email address
ufaqansari2014@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-01, 1402/10/11
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EFFECTIVENESS OF PROPRIOCEPTIVE PARADIGM IN ADDITION TO STRENGTH TRAINING PROGRAM IN CERVICAL RADICULOPATHY
Public title
Proprioceptive Paradigm in addition to strength training program in cervical radiculopathy.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30-55 years.
Both male and female.
Patients with pain or numbness of one or both arms.
Duration of symptoms is from more than 3 months.
Patients from both genders are diagnosed according to a careful clinical evaluation by the neurologist and diagnosis were confirmed radiologically by MRI and X-ray findings of the cervical spine.
To confirm the diagnosis of CR in addition to X-ray and MRI, Spurling test, upper limb tension test can also be used (Wang, 2022)
All patients are medically and psychologically stable (Kamal et al.).
Exclusion criteria:
Past fracture or surgery in cervical spine.
Deformity of the spine.
Inflammatory rheumatologic disease.
Vertebro basilar artery insufficiency.
Malignancy.
Cervical myelopathy.
Cervical myelo-radiculopathy.
Age
From 30 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were than randomized into two groups of equivalent number (study and control group) utilizing a secure method of opaque closed envelopes that is then assigned as group A (study) and group B (control).
Blinding (investigator's opinion)
Double blinded
Blinding description
It was double blinded study in which the subject (participant) and accessor were be blinded of the treatment provided in either group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Faculty of Allied Health Sciences The University of Lahore
Street address
House 7, Street 2, T Block New Multan
City
Multan
Postal code
60650
Approval date
2023-12-12, 1402/09/21
Ethics committee reference number
REC-UOL-655-01-2024
Health conditions studied
1
Description of health condition studied
Cervical Radiculopathy
ICD-10 code
M50.1
ICD-10 code description
Cervical disc disorder with radiculopathy
Primary outcomes
1
Description
Pain
Timepoint
Pre-treatment and Post-treatment
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Functional Disability
Timepoint
pre-treatment and Post-treatment
Method of measurement
NDI
2
Description
ROM
Timepoint
Pre-treatment and Post-treatment
Method of measurement
Laser Pointer Device
Intervention groups
1
Description
Intervention group: Proprioceptive Training Paradigm, Hot pack, TENS, Myofascial Release, Strength Training
Category
Rehabilitation
2
Description
Control group: Hot pack, TENS, Myofascial Release, Strength Training
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Allama Iqbal Teaching Hospital Dera ghazi khan
Full name of responsible person
Dr. Javeed Iqbal
Street address
Allama Iqbal Teaching Hospital Dera Ghazi khan
City
Dera Ghazi Khan
Postal code
32200
Phone
+92 303 5750338
Email
xcv678b@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Prof. Dr Ashfaq Ahmed
Street address
1-km Defense Road, near Bhuptian Chowk Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 42 111 865 865
Email
info@uol.edu.pk
Web page address
https://uol.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The University of Lahore
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
The University of Lahore
Full name of responsible person
Ufaq Hafeez
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House 7, Street 2, T Block New Multan
City
Multan
Province
punjab
Postal code
60650
Phone
+92 333 6125893
Email
ufaqansari2014@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University Of Lahore
Full name of responsible person
Iqra Waseem
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
University of Lahore Punjab Pakistan
City
Lahore
Province
Punjab
Postal code
54590
Phone
+92 334 7779399
Email
xcv678b@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of lahore
Full name of responsible person
Ufaq Hafeez
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House 7, Street 2, T Block New Multan
City
Multan
Province
Punjab
Postal code
60650
Phone
+92 61 4552420
Fax
Email
ufaqansari2014@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
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Effectiveness of Proprioceptive paradigm
When the data will become available and for how long
when published
To whom data/document is available
working in academic institution
Under which criteria data/document could be used
cannot be used
From where data/document is obtainable
Online website
What processes are involved for a request to access data/document
Sufficent information of applicant who want to access and why they want access