Protocol summary
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Study aim
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Evaluate the effects of instrument assisted soft tissue mobilization and deep transverse friction massage on pain and gait parameter among patients with Iliotibial band syndrome.
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Design
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Randomized clinical trial, Non-probability purposive sampling technique (random allocation to groups by means of lottery method) was used in this study.
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Settings and conduct
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• Physio Fixx Physiotherapy & Pain Relief Center, Faisalabad
• Physiotherapy & Pain Relief Center, Faisalabad
• Physiotherapist Center, Faisalabad
• Recovery Healthcare Clinic, Faisalabad
• InMotion Physiotherapy and Rehabilitation Clinic, Faisalabad
• Human Care Physiotherapy and Rehab Center, Faisalabad
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria
• Male patients with IT band tightness
• Sitting for minimum 6-7 hour
• Positive Ober’s test
• Age ranging between 25-45 years
• Having pain (3-7 on numeric pain rating scale)
• Willing to participate was included into study
Exclusion Criteria
• Participants with any diagnosed musculoskeletal or auto-immune disorder
• Having co-morbidities such as neoplasm etc
• Undergone lower limb surgery in past 6 months
• Having any neurological or vascular disorders or infectious disease
• Participants with physical impairment
• Participants taking medication (NSAIDS and steroids)
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Intervention groups
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For group A Instrument assisted soft tissue mobilization (IASTM) was given for 10 mins of warm up session using ultrasound as baseline treatment. For group B transverse deep friction massage was given along with the baseline treatment.
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Main outcome variables
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Pain, Range of motion, Q angle
General information
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Reason for update
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To update actual recruitment date
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Acronym
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IASTM (INSTRUMENT ASSISTED SOFT TISSUE MOBILIZATION), DTFM (DEEP TRANSVERSE FRICTION MASSAGE), ITBS (ILIOTIBIAL BAND SYNDROME)
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IRCT registration information
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IRCT registration number:
IRCT20230413057897N1
Registration date:
2023-08-18, 1402/05/27
Registration timing:
prospective
Last update:
2023-12-24, 1402/10/03
Update count:
1
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Registration date
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2023-08-18, 1402/05/27
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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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2023-08-20, 1402/05/29
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Expected recruitment end date
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2023-11-25, 1402/09/04
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Actual recruitment start date
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2023-08-25, 1402/06/03
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Actual recruitment end date
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2023-11-30, 1402/09/09
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Trial completion date
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2023-12-05, 1402/09/14
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Scientific title
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Comparative effects of instrument assisted soft tissue mobilization and deep transverse friction massage on pain and gait parameters of iliotibial band syndrome
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Public title
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Comparative effects of instrument assisted soft tissue mobilization and deep transverse friction massage on pain and gait parameters of iliotibial band syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Male patients with IT band tightness
Sitting for minimum 6-7 hour
Positive Ober’s test
Age ranging between 25-45 years
Having pain (3-7 on numeric pain rating scale)
Willing to participate will be included into study
Exclusion criteria:
Participants with any diagnosed musculoskeletal or auto-immune disorder
Having co-morbidities such as neoplasm etc
Undergone lower limb surgery in past 6 months
Having slump test negative
Having any neurological or vascular disorders or infectious disease
Participants with physical impairment
Participants taking medication (NSAIDS and steroids)
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Age
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From 25 years old to 45 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
24
Actual sample size reached:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Study is randomized control trial and purposive sampling technique (random
allocation to groups by means of lottery method) used in this study.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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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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2023-03-10, 1401/12/19
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Ethics committee reference number
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2021-MSPT-070
Health conditions studied
1
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Description of health condition studied
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ILIOTIBIAL BAND SYNDROME
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ICD-10 code
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M76.3
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ICD-10 code description
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Iliotibial band syndrome
2
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Description of health condition studied
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PAIN OF ILIOTIBIAL BAND SYNDROME
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ICD-10 code
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G89.29
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ICD-10 code description
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Other chronic pain
3
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Description of health condition studied
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GAIT IN ILIOTIBIAL BAND SYNDROME
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ICD-10 code
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R26.89
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ICD-10 code description
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Other abnormalities of gait and mobility
Primary outcomes
1
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Description
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Pain
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Timepoint
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Before intervention and 3 week after intervention
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Method of measurement
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Numerical Pain Raiting Scale
2
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Description
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Hip range of motion (abduction)
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Timepoint
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Before intervention and 3 week after intervention
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Method of measurement
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Goniometer
3
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Description
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Q angle
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Timepoint
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Before intervention and 3 week after intervention
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Method of measurement
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Goniometer
Intervention groups
1
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Description
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Intervention group: IASTM
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Category
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Treatment - Devices
2
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Description
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Intervention group: DTFM
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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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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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The University of Faisalabad
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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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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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Yes - There is 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
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Title and more details about the data/document
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all collected de identified participants data set for outcome measures.
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When the data will become available and for how long
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4 months
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To whom data/document is available
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people working in academic institutions.
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Under which criteria data/document could be used
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IPD and any other additional documents
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From where data/document is obtainable
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contact person: Hanan Abdullah Contact no. 92310-7436476
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What processes are involved for a request to access data/document
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Data will be provided by contacting the above mentioned person.
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Comments
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