To compare the effect of post isometric relaxation and hold relax agonist contract in improving pain and disability in mechanical neck pain
Design
Randomized clinical trial on 48 individuals (divided equally in two groups), randomization by lottery method, parallel groups, single-blind.
Settings and conduct
Ghurki trust and teaching hospital , Zahida welfare hospital . Assessor is blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: male and female; age range 18 to 45; duration of pain for 3 months; neck pain without radiating to arm; patients with mechanical neck pain diagnosed by orthopedist; pain increased by sustain posture; limitation of rotation and side flexion of neck. Exclusion criteria: history of neck surgery; stenosis; scoliosis; nerve involvement; neck pain radiation to arm; malignancy, infection, inflammatory disorder; shoulder pain
Intervention groups
Group- A (Muscle energy technique + supervised & home exercise program (HEP)
Group B ( Hold relax agonist contract +supervised + home exercise (HEP)
Main outcome variables
pain and disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200514047441N1
Registration date:2020-06-15, 1399/03/26
Registration timing:registered_while_recruiting
Last update:2020-06-15, 1399/03/26
Update count:0
Registration date
2020-06-15, 1399/03/26
Registrant information
Name
Aroosa Iqbal
Name of organization / entity
Riphah International University,Lahore, Pakistan
Country
Pakistan
Phone
+92 42 35753538
Email address
aroosaiqbal450@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-26, 1398/07/04
Expected recruitment end date
2020-08-01, 1399/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Post Isometric Relaxation and Hold Relax Agonist Contract in improving Pain and Disability in Mechanical Neck Pain
Public title
comparison of two MET techniques in mechanical neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and Female age range 18 to 45
Duration of pain 3 months
Neck pain without radiating to arm
Pain increased by sustain posture
Patients having mechanical neck pain diagnosed from orthopeadic
Limitation of rotation and side flexion of neck
Exclusion criteria:
History of neck surgery
stenosis
Scoliosis
Nerve involvement
Neck pain radiationg to arm
Malignancy, infection
inflammatory disorder
Shoulder pain
Age
From 18 years old to 45 years old
Gender
Both
Phase
4
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery method is used to divide subjects in two groups. A researcher will randomly picks numbers either 1 and 2. 1 will represent the group A ( post isometric relaxation) and 2 will represent group B ( hold relax agonist contract). Subjects will be randomly allocated in two treatment groups
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcomes assessor is blinded, they do not know about the allocation. A physiotherapist who works as outcome assessor takes pre and post treatment measurements
Placebo
Not used
Assignment
Parallel
Other design features
Randomized clinical trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Riphah International university
Street address
near Hajj complex I- 14, Islamabad, Islamabad capital territory
City
Islamabad
Postal code
46000
Approval date
2019-01-09, 1397/10/19
Ethics committee reference number
REC/RCRS/20/1027
Health conditions studied
1
Description of health condition studied
Neck pain is one of the most common musculoskeletal disorders mostly found in office worker, postural syndrome, anxiety, depression . Excessive forward head and neck flexion for a defined period of time would cause neck pain in healthy people
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia
Primary outcomes
1
Description
neck pain
Timepoint
before intervention and after 4 weeks
Method of measurement
Visual analogue scale to measure pain
2
Description
Improvement of neck disability
Timepoint
before intervention and after 4 weeks
Method of measurement
Neck disability index scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Muscle energy technique in form of post isometric relaxation will apply on upper trapezius, levator scapulae, scalene and sternocliedomastiod muscles along with hotpack and Tens. 3 treatment sessions will be given in a week. Initial measurement will be recorded before treatment and outcomes will be measured after 4 weeks through Neck disability index scale and Visual analogue scale.
Category
Treatment - Other
2
Description
Intervention group 2: Hold relax agonist contract will be performed on upper trapezius, levator scapulae,scalene and sternocliedomastiod muscles along with hot pack and Tens. 3 treatment sessions will be given in a week . Initial measurement will be recorded before treatment and outcomes will be measured after 4 weeks through Neck disability index scale and Visual analogue scale.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghurki Trust Teaching Hospital
Full name of responsible person
Aroosa Iqbal
Street address
H no 12 St no 1 Sami Town Lhr
City
Lahore
Postal code
53720
Phone
+92 42 35753538
Email
aroosaiqbal450@gmail.com
2
Recruitment center
Name of recruitment center
Zahida welfare hospital
Full name of responsible person
Aroosa Iqbal
Street address
H no 12 St no 1 Sami Town Lhr
City
Lahore
Postal code
53720
Phone
+92 42 36823416
Email
aroosaiqbal450@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
self
Full name of responsible person
Aroosa Iqbal
Street address
h no 12 st no 1 sami town lhr
City
Lahore
Postal code
53720
Phone
+92 42 35753538
Email
aroosaiqbal450@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
self
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
Riphah International university
Full name of responsible person
Aroosa Iqbal
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
H no 12 St no 1 sami town lhr
City
lahore
Province
punjab
Postal code
53720
Phone
+92 42 35753538
Email
aroosaiqbal450@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University,Lahore, Pakistan
Full name of responsible person
Aroosa Iqbal
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no 12 street 1 Sami town Lahore, Pakistan
City
Lahore
Province
Punjab
Postal code
53720
Phone
+92 42 35753538
Fax
Email
aroosaiqbal450@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University,Lahore, Pakistan
Full name of responsible person
Aroosa Iqbal
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no 12 street 1 Sami town Lahore, Pakistan
City
Lahore
Province
Punjab
Postal code
53720
Phone
+92 42 35753538
Fax
Email
aroosaiqbal450@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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