Back to resultsMetatarsophalangeal Joint Sprain Kinesiotaping
Primary Purpose
Turf Toe, Metatarsophalangeal (Joint) Sprain
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Traditional physical therapy program
Kinsio taping
placebo Kinsio taping
Sponsored by
About this trial
This is an interventional treatment trial for Turf Toe focused on measuring turf toe, Metatarsophalangeal Sprain, functional ability, gait parameters, kinesiology taping
Eligibility Criteria
Inclusion Criteria: comprised athletes with 2nd grade turf toe. medically stable. had foot pain for more than a month prior to enrollment. didn't have persistent, incapacitating pain. had a doctor's note approving their decision to stop taking painkillers during the research. Exclusion Criteria: if they had any surgical intervention before. range of motion limitation in the ankle joint. inability to exercise. systemic disease. any other orthopedic problem at ankle joints.
Sites / Locations
- Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
- King Khalid Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
exercise group
placebo kinesiology taping plus exercise group
kinesiology taping plus exercise group
Arm Description
60-minutes exercise program, three times a week on alternate days for 12 successive weeks.
Kinesiology taping was used, however the strain was zero. Before each exercise session, the tape was changed every two days while the patients were present.
putting no stress on the opposite end and a 50% stretch from the top of the big toe to the heel along the back of the heel. After applying a 50% stretch from the top of the big toe to the second horizontal little strip between the big toe and second toe, place the ends below the toe diagonally with no stress.
Outcomes
Primary Outcome Measures
Pain visual analog scale
The degree of the pain was assessed using a 10-cm visual analog scale (VAS), with 0 denoting no pain and 10 denoting the most painful event.
Pain visual analog scale
The degree of the pain was assessed using a 10-cm visual analog scale (VAS), with 0 denoting no pain and 10 denoting the most painful event.
Gait parameters (step length by centimeter).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Gait parameters (step length by centimeter).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Gait parameters (stride length by meter).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Gait parameters (stride length by meter).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Gait parameters (cadence by steps per minute).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Gait parameters (cadence by steps per minute).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Gait parameters (velocity by centimeter per second).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Gait parameters (velocity by centimeter per second).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Secondary Outcome Measures
Functional ability assessment
Functional ability was assessed using the 6-minute walk test.
Functional ability assessment
Functional ability was assessed using the 6-minute walk test.
Full Information
NCT ID
NCT05982431
First Posted
July 10, 2023
Last Updated
August 5, 2023
Sponsor
Qassim University
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University
1. Study Identification
Unique Protocol Identification Number
NCT05982431
Brief Title
Metatarsophalangeal Joint Sprain Kinesiotaping
Official Title
Kinesiology Taping Helps Patients With First Metatarsophalangeal Joint Sprain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
August 22, 2022 (Actual)
Study Completion Date
January 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
kinesio taping would reduce pain, improve gait performance, and enhance the functional capacity of turf toe patients undergoing physical therapy
Detailed Description
Health practitioners have recently become interested in using kinesiology taping in clinical practice as an alternative to traditional taping and bracing procedures for treating a variety of diseases, including sprain of metatarsophalangeal joint of the big toe. Patients with turf toe can benefit from kinesiology tape because it offers therapeutic support and stability while preserving a normal range of motion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Turf Toe, Metatarsophalangeal (Joint) Sprain
Keywords
turf toe, Metatarsophalangeal Sprain, functional ability, gait parameters, kinesiology taping
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise group
Arm Type
Experimental
Arm Description
60-minutes exercise program, three times a week on alternate days for 12 successive weeks.
Arm Title
placebo kinesiology taping plus exercise group
Arm Type
Experimental
Arm Description
Kinesiology taping was used, however the strain was zero. Before each exercise session, the tape was changed every two days while the patients were present.
Arm Title
kinesiology taping plus exercise group
Arm Type
Experimental
Arm Description
putting no stress on the opposite end and a 50% stretch from the top of the big toe to the heel along the back of the heel. After applying a 50% stretch from the top of the big toe to the second horizontal little strip between the big toe and second toe, place the ends below the toe diagonally with no stress.
Intervention Type
Other
Intervention Name(s)
Traditional physical therapy program
Other Intervention Name(s)
exercise program
Intervention Description
60-minutes exercise program, three times a week on alternate days for 12 successive weeks
Intervention Type
Other
Intervention Name(s)
Kinsio taping
Other Intervention Name(s)
kinesiology taping
Intervention Description
One full strip of kinesiology taping tape and one half-length strip were needed for the kinesiology taping application
Intervention Type
Other
Intervention Name(s)
placebo Kinsio taping
Other Intervention Name(s)
placebo kinesiology taping
Intervention Description
One full strip of kinesiology taping tape and one half-length strip were needed for the placebo kinesiology taping application
Primary Outcome Measure Information:
Title
Pain visual analog scale
Description
The degree of the pain was assessed using a 10-cm visual analog scale (VAS), with 0 denoting no pain and 10 denoting the most painful event.
Time Frame
at first week
Title
Pain visual analog scale
Description
The degree of the pain was assessed using a 10-cm visual analog scale (VAS), with 0 denoting no pain and 10 denoting the most painful event.
Time Frame
after 12 weeks
Title
Gait parameters (step length by centimeter).
Description
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Time Frame
at first week
Title
Gait parameters (step length by centimeter).
Description
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Time Frame
after 12 weeks
Title
Gait parameters (stride length by meter).
Description
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Time Frame
at first week
Title
Gait parameters (stride length by meter).
Description
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Time Frame
after 12 weeks
Title
Gait parameters (cadence by steps per minute).
Description
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Time Frame
at first week
Title
Gait parameters (cadence by steps per minute).
Description
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Time Frame
after 12 weeks
Title
Gait parameters (velocity by centimeter per second).
Description
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Time Frame
at first week
Title
Gait parameters (velocity by centimeter per second).
Description
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Time Frame
after 12 weeks
Secondary Outcome Measure Information:
Title
Functional ability assessment
Description
Functional ability was assessed using the 6-minute walk test.
Time Frame
at first week
Title
Functional ability assessment
Description
Functional ability was assessed using the 6-minute walk test.
Time Frame
after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
comprised athletes with 2nd grade turf toe.
medically stable.
had foot pain for more than a month prior to enrollment.
didn't have persistent, incapacitating pain.
had a doctor's note approving their decision to stop taking painkillers during the research.
Exclusion Criteria:
if they had any surgical intervention before.
range of motion limitation in the ankle joint.
inability to exercise.
systemic disease.
any other orthopedic problem at ankle joints.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alshimaa Azab, PhD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
City
Al-Kharj
State/Province
Riyadh
ZIP/Postal Code
11432
Country
Saudi Arabia
Facility Name
King Khalid Hospital
City
Al-Kharj
State/Province
Riyadh
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
Citations:
PubMed Identifier
23306413
Citation
Mostafavifar M, Wertz J, Borchers J. A systematic review of the effectiveness of kinesio taping for musculoskeletal injury. Phys Sportsmed. 2012 Nov;40(4):33-40. doi: 10.3810/psm.2012.11.1986.
Results Reference
background
PubMed Identifier
21673494
Citation
Burr JF, Bredin SS, Faktor MD, Warburton DE. The 6-minute walk test as a predictor of objectively measured aerobic fitness in healthy working-aged adults. Phys Sportsmed. 2011 May;39(2):133-9. doi: 10.3810/psm.2011.05.1904.
Results Reference
background
PubMed Identifier
29158472
Citation
Kim MK, Shin YJ. Immediate Effects of Ankle Balance Taping with Kinesiology Tape for Amateur Soccer Players with Lateral Ankle Sprain: A Randomized Cross-Over Design. Med Sci Monit. 2017 Nov 21;23:5534-5541. doi: 10.12659/msm.905385.
Results Reference
background
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Metatarsophalangeal Joint Sprain Kinesiotaping
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