Protocol summary
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Study aim
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This study aimed to elucidate the effects of the posture correction band on the pulmonary function and chest expansion in young adults with forward head posture.
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Design
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Randomized Control Trial
(G1: Posture Correction Belt)
(G2: No Treatment)
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Settings and conduct
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Physiotherapy clinic named Johar Pain Relief Center Lahore, Pakistan
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria:
• Had a cranio-vertebral angle less than 50°
• Had some neck pain and disability, less than 5 as measured by Urdu version of the neck disability index (NDI).
Exclusion criteria
• had a history of spinal or chest surgery
• had a history of smoking
• had an acute or chronic neuromusculoskeletal pain
• had severe obesity (body mass index > 40), diabetes, or malignant tumors
• had clinical abnormalities or severe comorbidities.
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Intervention groups
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Subjects were divided in two groups. G1 group will be the treatment group who wore posture correction belt for 2 hours and their Pulmonary Function Test (PFT) will be performed after that. G2 group will be control group. The PFT of this group individuals were performed without the trial of posture belt. PFT will be performed two times: before and immediately after undressing the postural band. Vital capacity (VC), forced vital capacity (FVC), peak expiratory flow (PEF), and forced expiratory volume at one second (FEV1) were measured. Chest expansion will be also measured with measuring tape before and after undressing posture belt.
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Main outcome variables
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Main outcome variables are vital capacity, forced vital capacity, peak expiratory flow, forced expiratory volume in one second and chest expansion
General information
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Reason for update
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Due to Covid-19 Wave spread, could not start the trial.
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Acronym
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PFT, FHP
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IRCT registration information
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IRCT registration number:
IRCT20191117045462N4
Registration date:
2021-08-16, 1400/05/25
Registration timing:
prospective
Last update:
2021-09-02, 1400/06/11
Update count:
1
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Registration date
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2021-08-16, 1400/05/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-06-01, 1400/03/11
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Expected recruitment end date
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2021-08-01, 1400/05/10
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Actual recruitment start date
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2021-09-01, 1400/06/10
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Actual recruitment end date
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2021-12-31, 1400/10/10
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Trial completion date
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2022-02-01, 1400/11/12
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Scientific title
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Effects of Posture Correction Band on Pulmonary Function and Chest Expansion in Asymptomatic Population with Forward Head Posture
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Public title
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Effects of Posture Correction Band on Pulmonary Function and Chest Expansion in Asymptomatic Population with Forward Head Posture
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Had a cranio-vertebral angle less than 50°
Had some neck pain and disability, less than 5 as measured by Urdu version of the neck disability index (NDI).
Exclusion criteria:
Had a history of spinal or chest surgery
Had a history of smoking
Had an acute or chronic neuromusculoskeletal pain
Had severe obesity (body mass index > 40), diabetes, or malignant tumors
Had clinical abnormalities or severe comorbidities.
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Age
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From 18 years old to 45 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
42
More than 1 sample in each individual
Number of samples in each individual:
2
spirometry and chest expansion with measuring tape before and after treatment
Actual sample size reached:
42
More than 1 sample in each individual
Actual sample size in each individual:
2
spirometry and chest expansion with measuring tape before and after treatment
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be recruited in the study through a convenient sampling technique and then will be randomly
assigned to each group through Random Sampling sealed opaque enveloped. Labeled as 1 for group G1 and 2 for group G2. Half enveloped will be labeled with 1 and a half with labeled 2. If a patient gets the envelope with label 1 then will be treated in group G1, and if a patient gets the envelope with label 2 that will be treated in group G2.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Accessor therapist will be blind. He will only document outcome variables but treatment will be provided by the other therapist.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-03-19, 1399/12/29
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Ethics committee reference number
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RCRS-RE-MSPT-CPPT/Spring 20/060
Health conditions studied
1
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Description of health condition studied
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Forward Head Posture: Forward head posture (FHP) defines as an increased curvature of the cervical vertebrae due to the extension of head and upper cervical vertebrae (Cl-C3) and the flexion of the lower cervical vertebrae (C4-C7), resulting in the forward head posture.
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ICD-10 code
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R29.3
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ICD-10 code description
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Abnormal posture
2
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Description of health condition studied
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Neck pain is associated with Forward head posture.
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ICD-10 code
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M54.2
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ICD-10 code description
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Cervicalgia
Primary outcomes
1
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Description
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Vital Capacity (VC)
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Timepoint
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Pre and Post treatment (2 hours)
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Method of measurement
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Pulmonary function test: spirometer
2
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Description
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Forced Vital Capacity (FVC)
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Timepoint
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Pre and Post treatment (2 hours)
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Method of measurement
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Pulmonary function test: spirometer
3
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Description
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Peak Expiratory Flow (PEF)
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Timepoint
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Pre and Post Treatment (2 hours)
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Method of measurement
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Pulmonary function test: spirometer
4
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Description
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Forced Expiratory Volume at one second (FEV1)
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Timepoint
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Pre and Post Treatment (2 hours)
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Method of measurement
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Pulmonary function test: spirometer
5
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Description
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Chest Expansion
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Timepoint
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Pre and Post Treatment (2 hours)
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Method of measurement
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Measuring Tape
Intervention groups
1
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Description
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Intervention group: G1 group will be the treatment group who wore posture correction belt for 2 hours and their Pulmonary Function Test (PFT) and chest expansion will be measured after that. PFT and chest expansion measurements will be performed two times: before dressing the posture correction band and immediately after undressing the postural band.
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Category
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Treatment - Devices
2
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Description
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Control group: G2 group will be control group. The PFT of this group individuals were performed without the trial of posture belt.
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Category
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Lifestyle
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Riphah College of Rehanilitation and Allied Health Sciences
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All collected deidentified IPD, IPD collected for the primary outcome measure
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When the data will become available and for how long
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Starting 6 months after publication
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To whom data/document is available
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Academic institutions
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Under which criteria data/document could be used
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All the data will remain under the management of academic institution under whom research work is being done. the authorized person by the university will be responsible for reviewing requests.
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From where data/document is obtainable
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wajeeha_z@yahoo.com
mohtishim_7@hotmail.com
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What processes are involved for a request to access data/document
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To access data, the person can simply emailed on the specified email for request to access data. probably email will be answered within a day. After that the requestee must clearly mention the reason for accessing data along with some other details mentioned on the form. the data will be provided in 3 days after proper workup by the responsible person
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Comments
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