COMPARATIVE EFFECTIVENESS OF ROUTINE PHYSICAL THERAPY WITH AND WITHOUT INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION IN PATIENTS WITH NECK PAIN DUE TO UPPER CROSSED SYNDROME
To determine the effectiveness of routine physical therapy with and without IASTM technique on pain intensity, range of motion and neck pain disability index in patients with neck pain due to upper crossed syndrome.
Design
Randomized Clinical Trail
Settings and conduct
The data will be collected from Physiotherapy Clinics, The Agile Institute of rehabilitation Sciences( AIRS) and National Orthopedic Hospital Bahawalpur.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Diagnosed patients complaining neck pain with forwarded head posture
• Both Females and Males in age of 18-40
• Chronic Neck pain from at least 3 months
• Neck pain Scoring More than 3 on Visual Analogue Scale
Exclusion Criteria
Patients with history of
• Any previous surgery
• Any type of Infection
• Any type of Hypersensitive Skin
• Diabetes Mellitus type II
• Any type of Traumatic Injury
• Any type of Psychological Disorder
• Manual therapy contraindicated like osteoporosis, infection, disc-Herniation, neoplasm
• Osteomyelitis, Ulcers, open wound including all in which IASTM is contraindicated
• Rheumatoid Arthritis
• Acute Inflammation
• Burn Scars
• Osteoporosis
• Unhealed , closed and non complicated fractures
Pain
Cervical Range of Motion
Neck Disability Index(Functional Assessment Tool)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190912044754N1
Registration date:2020-01-19, 1398/10/29
Registration timing:prospective
Last update:2020-01-19, 1398/10/29
Update count:0
Registration date
2020-01-19, 1398/10/29
Registrant information
Name
Tahir Mahmood
Name of organization / entity
Agile Insitute of Rehabilitation Sciences ,Bahawalpur
Country
Pakistan
Phone
+92 62 2888596
Email address
tahirmahmoodphysio@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2640-12-11, 2019/09/20
Expected recruitment end date
2641-04-09, 2020/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
COMPARATIVE EFFECTIVENESS OF ROUTINE PHYSICAL THERAPY WITH AND WITHOUT INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION IN PATIENTS WITH NECK PAIN DUE TO UPPER CROSSED SYNDROME
Public title
COMPARATIVE EFFECTIVENESS OF ROUTINE PHYSICAL THERAPY WITH AND WITHOUT INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION IN PATIENTS WITH NECK PAIN DUE TO UPPER CROSSED SYNDROME
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed patients complaining neck pain with forwarded head posture,
Both Females and Males in age of 18-40,
Chronic Neck pain from at least 3 months,
Neck pain Scoring More than 3 on Visual Analogue Scale
Limited Cervical ROM
Exclusion criteria:
Patients with history of•
Any previous surgery
Any type of Infection
Any type of Hypersensitive Skin
Diabetes Mellitus type II
Any type Traumatic Injury
Any type Psychological Disorder
Manual therapy contraindicated like osteoporosis, infection, disc-Herniation, neoplasm•
Rheumatoid Arthritis
Acute Inflammation
Burn Scars
Osteoporosis
Unhealed , closed and non complicated fractures
Osteomyelitis, Ulcers, open wound including all in which IASTM is contraindicated
Age
From 18 years old to 40 years old
Gender
Both
Phase
0
Groups that have been masked
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects fulfilling the inclusion criteria will be enrolled after independent outcome assessor .Then coin toss method is being used for randomization .The coin thrown in air having two sides with label "A" and "B".
The subjects randomization method reduces the chances of bias group allocation .
Blinding (investigator's opinion)
Single blinded
Blinding description
It will be single blind and assessor will be blind .All assessments before and after the intervention will be done by Independent assessor and only eligible subjects will be enrolled . Neck Range of Motion ,Neck disability Index and Pain will be measured .Then subjects will be kept confidential and only it will be given after the assessor has completed an assessment at baseline , after 02 weeks and 04 weeks
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of The University of Lahore "Institutional Review Board"
Street address
defence road campus,new campus ,The University of Lahore
City
Lahore
Postal code
54000
Approval date
2640-11-20, 2019/08/29
Ethics committee reference number
IRB-UOL-FAHS/670/2019
Health conditions studied
1
Description of health condition studied
Upper Crossed Syndrome
ICD-10 code
R29.3
ICD-10 code description
Abnormal posture
Primary outcomes
1
Description
Pain Intensity
Timepoint
on baseline ,then after 2 weeks and then after weeks
Method of measurement
Numeric Pain Rating Scale
2
Description
Neck range of Motion
Timepoint
On baseline ,then after 2 weeks and then after weeks
Method of measurement
Inclinometer
3
Description
Neck Disability Index
Timepoint
On baseline ,then after 2 weeks and then after weeks
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Academic support Only
Proportion provided by this source
20
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
Agile Institute of Rehabilitation Sciences
Full name of responsible person
Tahir Mahmood
Position
Lecturer/Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Noor Mahal Road
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 62 2888596
Fax
+92 62 2888596
Email
tahirmahmoodphysio@gmail.com
Web page address
https://airs.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Agile Institute of Rehabilitation Sciences
Full name of responsible person
Tahir
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Noor Mahal Road Bahawalpur
City
Bahawapur
Province
Punjab
Postal code
63100
Phone
0920622888596
Fax
+92 62 2888596
Email
drhafeezarain@gmail.com
Web page address
https://airs.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Agile Institute of Rehabilitation Sciences
Full name of responsible person
Tahir Mahmood
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Noor Mahal Road Bahawalpur
City
Bahawapur
Province
Punjab
Postal code
63100
Phone
0920622888596
Fax
+92 62 2888596
Email
drhafeezarain@gmail.com
Web page address
https://airs.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Title and more details about the data/document
Effectiveness of routine physical therapy with and without IASTM in patients with neck pain due to upper crossed syndrome
Instrument Assisted Soft Tissue Mobilization Technique for Upper crossed Syndrome
When the data will become available and for how long
It will be available after study completion
To whom data/document is available
To researchers for study only.Patient data will not be shown .
Under which criteria data/document could be used
under the usage with terms in which journal is accessed /processed for publication
From where data/document is obtainable
from the University office and Responsible supervisor and from journal we will process in future
What processes are involved for a request to access data/document
It will be only used in confidential way for improving research and benefit of humanity
Comments
It will be first study of such type in pakistan using Soft Tissue mobilization technique which is instrument assisted that is the only reason study has a motivational factor and researchers are waiting for its results .