Protocol summary
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Study aim
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The purpose of the study was to compare the EFFECTIVENESS OF INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION VERSUS CYRIAX TECHNIQUE FOR MUSCULAR NECK PAIN IN LABORATORY WORKERS
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Design
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A concealed Randomized ,single blinded, controlled trial with a good design of 96 participants.
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Settings and conduct
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Study was conducted at 1.• Family hospital and maternity home, Multan 2. •BUCH International Hospital, Multan.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Both Male and Female ,Age 18-45years ,Neck pain on visual analogue scale(VAS) 4-8 (moderate cases), Subacute or chronic cases (4-12 weeks) Exclusion criteria: Not willing to participate,
Joint with history of trauma, fracture and degenerative joint disease ,Tumor and rheumatic disease ,Patient diagnose with any bony lesion, Skin infection, Vestibular balance disorder.
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Intervention groups
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The exercise regime distributed over 06 weeks period(18 sessions) once a day and 03 times per week. Group-A received a treatment program consisting of Instrument assisted soft tissue mobilization. Group-B received cyriax deep friction massage technique. Both groups received gel application before treatment procedure.
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Main outcome variables
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Pain, Range of motion, Functional status.
General information
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Reason for update
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Acronym
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muscular neck pain
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IRCT registration information
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IRCT registration number:
IRCT20230316057740N1
Registration date:
2023-09-08, 1402/06/17
Registration timing:
retrospective
Last update:
2023-09-09, 1402/06/18
Update count:
1
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Registration date
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2023-09-08, 1402/06/17
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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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2023-07-27, 1402/05/05
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Expected recruitment end date
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2023-08-27, 1402/06/05
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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EFFECTIVENESS OF INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION VERSUS CYRIAX TECHNIQUE FOR MUSCULAR NECK PAIN IN LABORATORY WORKERS
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Public title
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INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION VERSUS CYRIAX TECHNIQUE FOR MUSCULAR NECK PAIN IN LABORATORY WORKERS
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Both Male and Female
Age 18-45years
Neck pain on visual analogue scale(VAS) 4-8 (moderate cases)
Subacute or chronic cases (4-12 weeks)
Exclusion criteria:
Not willing to participate
Joint with history of trauma, fracture and degenerative joint disease
Tumor and rheumatic disease
Patient diagnose with any bony lesion
Skin infection
Vestibular balance disorder
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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:
96
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A total of 96 participants will be randomly divided into two groups by the lottery method. Each member of the population will be assigned a number, after which numbers will be selected at random.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Data analyzer was unaware of the results. Data analyzer was unaware of the treatments received by group-A and group-B. Data analyzer was blinded to the results.
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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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No
Ethics committees
1
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Ethics committee
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Approval date
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2023-03-02, 1401/12/11
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Ethics committee reference number
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MIMAS/IRB/02/03/Usman
Health conditions studied
1
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Description of health condition studied
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Muscular Neck Pain
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ICD-10 code
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M54.0
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ICD-10 code description
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Muscular Neck Pain
Primary outcomes
1
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Description
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Pain
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Timepoint
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before and after treatment (06 weeks)
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Method of measurement
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Numeric Pain Rating Scale (NPRS)
2
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Description
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Range of motion
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Timepoint
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before and after treatment (06 weeks)
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Method of measurement
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Gonoimeter
3
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Description
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Functional disability
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Timepoint
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before and after treatment (06 weeks)
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Method of measurement
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Neck Disability Index (NDI)
Secondary outcomes
1
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Description
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Functionality
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Timepoint
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before and after treatment (06 weeks)
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Method of measurement
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NDI (Neck Disability Index)
2
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Description
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Pain
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Timepoint
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before and after treatment (06 weeks)
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Method of measurement
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NPRS (Numeric Pain Rating Scale)
3
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Description
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Range of motion
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Timepoint
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before and after treatment (06 weeks)
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Method of measurement
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Goniometry
Intervention groups
1
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Description
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Intervention group: Group-A will be treated with Instrument assisted soft tissue mobilization for about 5 to 7 minutes of duration. This technique is done by specially made devices which used to perform soft tissue mobilization. These devices are available in different shapes and sizes. Gel is applied to treatment area before the proceedings. Gently massage done with special devices for about 5 to 7 minutes. The duration of the treatment is (06 weeks). The frequency of the treatment is 03 times a week and each session lasted for about 10 minutes.
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Category
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Treatment - Other
2
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Description
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Intervention group: Group-B will be treated with cyriax deep friction massage for about 5 to 7 minutes. Gel applied to treatment surfaces before session. Gently manual massage given to patients. The duration of the treatment is (06 weeks). The frequency of the treatment is 03 times a week and each session lasted for about 10 minutes.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Imran Ahmad Khan
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Grant code / Reference number
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Muhammad Institute Of Medical and Allied Sciences, Multan.
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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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Muhammad Institute Of Medical and Allied Sciences, Multan
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available