To compare the effect of functional exercises and neck isometrics exercises in patients with non-specific neck pain in terms of reducing pain and functional ability of neck.
Design
Randomized Control Trial.
Settings and conduct
A Private Physiotherapy Clinic, Ehsan’s Rehab, in Lahore, Pakistan.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Patients of both genders aged between 30-45 years will be included in the study.
• Patients having acute or sub-acute neck pain for duration less than 12 weeks.
• Patients having moderate and severe pain.
Exclusion criteria:
• Patients having non-specific neck pain along with any major pathology will be excluded.
• If they present with any trauma, whiplash injury, history of malignancy or neoplasm, cervical radiculopathy, fractures of cervical or thoracic region.
• If the patients present with neurologic diseases such as stroke, Parkinson’s disease or multiple sclerosis.
• Patients with acute neck pain having inflammation will be excluded.
• Patients having limited shoulder ROM due to any shoulder pathology.
Intervention groups
Group A
Conventional physiotherapy which include moist heat that will be applied on the cervical region of the patient along with TENS. Then the patient will be instructed by the Physiotherapist to perform the active ROM of neck, Neck stabilization exercises. The Physiotherapist will then perform optimal loading neck isometrics on patients.
Group B
Conventional physiotherapy which include moist heat that will be applied on the cervical region of the patient along with TENS. Then the patient will be instructed by the Physiotherapist to perform the active ROM of neck, Neck stabilization exercises. Patients then perform functional exercises which include ergo meter training and thera-ball exercises.
Main outcome variables
Pain, Functional disability
General information
Reason for update
Acronym
EFEVNIOWNNP
IRCT registration information
IRCT registration number:IRCT20220714055471N1
Registration date:2023-01-23, 1401/11/03
Registration timing:retrospective
Last update:2023-01-23, 1401/11/03
Update count:0
Registration date
2023-01-23, 1401/11/03
Registrant information
Name
Ambreen Iqbal
Name of organization / entity
University of South Asia, Lahore
Country
Pakistan
Phone
+92 42 35787905
Email address
ambreen.iqbal@usa.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-08, 1400/11/19
Expected recruitment end date
2022-06-10, 1401/03/20
Actual recruitment start date
2022-02-08, 1400/11/19
Actual recruitment end date
2022-06-10, 1401/03/20
Trial completion date
2022-08-19, 1401/05/28
Scientific title
EFFECT OF FUNCTIONAL EXERCISES VERSUS NECK ISOMETRICS EXERCISES IN PATIENTS WITH NON- SPECIFIC NECK PAIN
Public title
EFFECT OF FUNCTIONAL EXERCISES VERSUS NECK ISOMETRICS EXERCISES IN PATIENTS WITH NON- SPECIFIC NECK PAIN
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of both genders aged between 30-45 years will be included in the study.
Patients having acute or sub-acute neck pain for duration less than 12 weeks.
Patients having moderate and severe pain.
Exclusion criteria:
Patients having non-specific neck pain along with any major pathology will be excluded.
If they present with any trauma, whiplash injury, history of malignancy or neoplasm, cervical radiculopathy, fractures of cervical or thoracic region.
If the patients present with neurologic diseases such as stroke, Parkinson’s disease or multiple sclerosis.
Patients with acute neck pain having inflammation will be excluded.
Patients having limited shoulder ROM due to any shoulder pathology.
Age
From 30 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be selected randomly through Lottery Method. Each member will get equal chance of being included in the study. The patients meeting the inclusion criteria will be allowed to pick an envelope placed in a container, in which the group number will be mentioned and before folding that paper, the number will not be visible to any of the patient or practitioners. By this the patients will be divided into two groups: Group A and Group B. Group A will be the control group and Group B will be the experimental group in this study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and assessor will be blind to the treatment.
Baseline assessment will be performed by the assessor in a separate room before treatment group allocation.
The patients according to different groups will be called for the treatment on different timings.
After the completion of treatment sessions, the final assessment of patients will be done by the assessor .
The treatment group allocation of patients will not be revealed to assessor
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional review board, University of South Asia
Street address
47 Tufail Rd, Cantt, Lahore, Punjab
City
Lahore
Postal code
54800
Approval date
2021-12-13, 1400/09/22
Ethics committee reference number
IRB-USA-FLHS/53/2021
Health conditions studied
1
Description of health condition studied
Non specific neck pain
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia
Primary outcomes
1
Description
Pain
Timepoint
baseline and after 2 weeks
Method of measurement
NPRS
2
Description
Functional disability
Timepoint
Baseline and after 2 weeks
Method of measurement
NDI
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Rehabilitation
2
Description
Intervention group:
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ehsan's Rehab And Sports Injury Clinic,Lahore.
Full name of responsible person
Dr.Ahsan Javed
Street address
House no.35, Block G Gulberg 2, Lahore, Punjab
City
Lahore
Postal code
54660
Phone
+92 300 8451848
Email
ahsan.javed@usa.ed.pk
Web page address
https://www.ehsanrehab.com/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University Of South Asia,Lahore
Full name of responsible person
Ambreen Iqbal
Street address
47 Tufail Rd, Saddar Town, Lahore, Punjab
City
Lahore
Postal code
54800
Phone
+92 322 7617154
Email
ambreen.iqbal@usa.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University Of South Asia,Lahore
Proportion provided by this source
15
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
University Of South Asia,Lahore
Full name of responsible person
Ambreen Iqbal
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
117,Block A, PIA Society ,Lahore.
City
Lahore
Province
Punjab
Postal code
54800
Phone
+92 322 7616154
Email
iqbalambreen8@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University Of South Asia, Lahore
Full name of responsible person
Ambreen Iqbal
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no 117 block A ,PIA society,Lahore
City
Lahore
Province
Punjab
Postal code
54782
Phone
+92 322 7616154
Email
iqbalambreen8@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University Of South Asia,Lahore
Full name of responsible person
Ambreen Iqbal
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
47 Tufail Rd, Saddar Town, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
54800
Phone
+92 322 7616154
Email
iqbalambreen8@gmail.com
Web page address
https://usa.edu.pk/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available