THE EFFECTS OF FUNCTIONAL RELEASE AND POSITIONAL RELEASE TECHNIQUES ON UPPER TRAPEZIUS MYALGIA AND CERVICAL RANGE OF MOTION; “A DOUBLE BLINDED RANDOMIZED CONTROLLED TRIAL”.
Northwest General Hospital & Research Centre Peshawar, Pakistan.
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA
1. Age 18 to 45 years with Upper Trapezius myalgia.
2. Males/females.
3. Pain intensity of 4 to 7 on NPRS will be included in the study.
4. Pain for more than one week.
EXCLUSION CRITERIA
1. A patient will be excluded if suffering from, acute facet joint locking, and pregnancy
2. Patient with cervical radiculopathy, ligamentous instability, and recent TOS (Through
special tests).
3. Diagnosed cases of Fibro-myalgia syndrome, fractures, and recent injuries to the
shoulder or cervical spine, neck, vascular disorder, scapula or any surgical procedures.
Intervention groups
treatment group one receive functional release technique and treatment group two receive positional release technique
Main outcome variables
To determine the short term effects of functional release and positional release technique for
upper Trapezius myalgia and cervical range of motion.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231027059868N1
Registration date:2023-11-18, 1402/08/27
Registration timing:registered_while_recruiting
Last update:2023-11-18, 1402/08/27
Update count:0
Registration date
2023-11-18, 1402/08/27
Registrant information
Name
Ayesha .
Name of organization / entity
Khyber medical university Peshawar Pakistan
Country
Pakistan
Phone
+92 91 9217703
Email address
ayeshameedpt@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-31, 1402/08/09
Expected recruitment end date
2023-12-15, 1402/09/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
THE EFFECTS OF FUNCTIONAL RELEASE AND POSITIONAL RELEASE TECHNIQUES ON UPPER TRAPEZIUS MYALGIA AND CERVICAL RANGE OF MOTION; “A DOUBLE BLINDED RANDOMIZED CONTROLLED TRIAL”.
Public title
THE EFFECTS OF FUNCTIONAL RELEASE AND POSITIONAL RELEASE TECHNIQUES ON UPPER TRAPEZIUS MYALGIA AND CERVICAL RANGE OF MOTION; “A DOUBLE BLINDED RANDOMIZED CONTROLLED TRIAL”.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 45 years with Upper Trapezius myalgia..
Males/females
Pain intensity of 4 to 7 on NPRS will be included in the study.
Pain for more than one week.
Exclusion criteria:
A patient will be excluded if suffering from, acute facet joint locking, and pregnancy
Patient with cervical radiculopathy, ligamentous instability, and recent TOS (Through special tests).
Diagnosed cases of Fibro-myalgia syndrome, fractures, and recent injuries to the shoulder or cervical spine, neck, vascular disorder, scapula or any surgical procedures.
Age
From 14 years old to 45 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants’ recruitment for the study were be done through non-probability convenience sampling and then randomly assigned to either group A or group B through sealed envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
the subjects will be divided into two groups, thirty subjects in each group will be recruited from
NWGH’s Musculoskeletal Physiotherapy OPD. Informed consent will be taken from every
single subject in their language best understood by them. The participants will not be inform about their group assignments prior to randomization. A consent form will be obtained once the patients fulfill the inclusion criteria. All of the participants required to choose one of the 60 papers from an envelope
following the first evaluation round. Thirty papers had TG1 printing, and the remaining had
TG2 printing. The papers in the envelope all will be mixed up. Each participant's choice of
paper led to their appropriate grouping, which was TG1 for the FRT group and TG2 for the
PRT. The volunteers selected also unaware of their group's features, and both groups will be
assessed by an experienced physiotherapist colleague, who is also unaware about participate
allocation in groups. Every participant received a total of three sessions per day for one week.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
KHYBER MEDICAL UNIVERSITY ETHICS BOARD.
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa 25100
City
PESHAWAR
Postal code
25000
Approval date
2023-06-20, 1402/03/30
Ethics committee reference number
091-9217258
Health conditions studied
1
Description of health condition studied
.
ICD-10 code
M79.1
ICD-10 code description
Myalgia
Primary outcomes
1
Description
to decrease pain
Timepoint
1, 3, 7 day after intervention
Method of measurement
Numerical pain rating scale ,and goniometer for Range of motion
Northwest General Hospital & Research Centre Peshawar, Pakistan.
Full name of responsible person
Ayesha
Street address
Landi Akhoon Ahmad opposite Sarhad university ring road Peshawar
City
Peshawar
Postal code
25000
Phone
+92 91 5862514
Email
ayeshameedpt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khyber Medical University
Full name of responsible person
Ayesha
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa 25100
City
Peshawar
Postal code
25000
Phone
+92 91 5862514
Email
ayeshameedpt@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khyber Medical University
Proportion provided by this source
50
Public or private sector
Public
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
Khyber Medical University
Full name of responsible person
Ayesha
Position
MS Scholar
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa 25100
City
Peshawar
Province
Khyber Pakhtunkhwa, Pakistan.
Postal code
25000
Phone
+92 91 5862514
Email
ayeshameedpt@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khyber Medical University
Full name of responsible person
Ayesha
Position
MS scholar
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa 25100
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25000
Phone
+92 91 5862514
Email
ayeshameedpt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khyber Medical University
Full name of responsible person
Ayesha
Position
MS scholar
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa 25100
City
Peshawar
Province
Khyber Pakhtunkhwa, Pakistan
Postal code
25000
Phone
+92 91 5862514
Email
ayeshameedpt@gmail.com
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
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
Title and more details about the data/document
THE EFFECTS OF FUNCTIONAL RELEASE AND POSITIONAL RELEASE TECHNIQUES ON UPPER TRAPEZIUS MYALGIA AND CERVICAL RANGE OF MOTION; “A DOUBLE BLINDED RANDOMIZED CONTROLLED TRIAL”
When the data will become available and for how long
data will be available for researchers, scholars and students
To whom data/document is available
data will bee available for master students and registered participants with IRCT.
Under which criteria data/document could be used
data will bee available for master students and registered participants with IRCT.
From where data/document is obtainable
data will be obtained by emailing the principle author .(ayeshameedpt@gmail.com)
What processes are involved for a request to access data/document
the researcher who required data mail the concern author..(ayeshameedpt@gmail.com)