Metatarsophalangeal Joint Sprain Kinesiotaping

• ClinicalTrials.gov Identifier: NCT05982431
• Recruitment Status: Completed
• First Posted: August 8, 2023
• Last Update Posted: August 8, 2023
• Sponsor: Qassim University
• Collaborators: Cairo University; Prince Sattam Bin Abdulaziz University
• Information provided by (Responsible Party): Maged Basha, Qassim University

Tracking Information

• First Submitted Date: July 10, 2023
• First Posted Date: August 8, 2023
• Last Update Posted Date: August 8, 2023
• Actual Study Start Date: September 10, 2021
• Actual Primary Completion Date: August 22, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 5, 2023)

• Pain visual analog scale [ Time Frame: at first week ]
  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 [ Time Frame: after 12 weeks ]
  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). [ Time Frame: at first week ]
  The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
• Gait parameters (step length by centimeter). [ Time Frame: after 12 weeks ]
  The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
• Gait parameters (stride length by meter). [ Time Frame: at first week ]
  The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
• Gait parameters (stride length by meter). [ Time Frame: after 12 weeks ]
  The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
• Gait parameters (cadence by steps per minute). [ Time Frame: at first week ]
  The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
• Gait parameters (cadence by steps per minute). [ Time Frame: after 12 weeks ]
  The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
• Gait parameters (velocity by centimeter per second). [ Time Frame: at first week ]
  The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
• Gait parameters (velocity by centimeter per second). [ Time Frame: after 12 weeks ]
  The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 5, 2023)

• Functional ability assessment [ Time Frame: at first week ]
  Functional ability was assessed using the 6-minute walk test.
• Functional ability assessment [ Time Frame: after 12 weeks ]
  Functional ability was assessed using the 6-minute walk test.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Metatarsophalangeal Joint Sprain Kinesiotaping
• Official Title: Kinesiology Taping Helps Patients With First Metatarsophalangeal Joint Sprain
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Turf Toe
• Metatarsophalangeal (Joint) Sprain

Intervention

• Other: Traditional physical therapy program
  60-minutes exercise program, three times a week on alternate days for 12 successive weeks
  Other Name: exercise program
• Other: Kinsio taping
  One full strip of kinesiology taping tape and one half-length strip were needed for the kinesiology taping application
  Other Name: kinesiology taping
• Other: placebo Kinsio taping
  One full strip of kinesiology taping tape and one half-length strip were needed for the placebo kinesiology taping application
  Other Name: placebo kinesiology taping

Study Arms

• Experimental: exercise group
  60-minutes exercise program, three times a week on alternate days for 12 successive weeks.
  Intervention: Other: Traditional physical therapy program
• Experimental: placebo kinesiology taping plus exercise group
  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.
  Interventions:

  • Other: Traditional physical therapy program
  • Other: placebo Kinsio taping
• Experimental: kinesiology taping plus exercise group
  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.
  Interventions:

  • Other: Traditional physical therapy program
  • Other: Kinsio taping

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 5, 2023): 60
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 15, 2023
• Actual Primary Completion Date: August 22, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 30 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Saudi Arabia

Administrative Information

• NCT Number: NCT05982431
• Other Study ID Numbers: RHPT/0021/0063
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
• Supporting Materials: Study Protocol
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

• Current Responsible Party: Maged Basha, Qassim University
• Original Responsible Party: Same as current
• Current Study Sponsor: Qassim University
• Original Study Sponsor: Same as current

Collaborators

• Cairo University
• Prince Sattam Bin Abdulaziz University

Investigators

• Principal Investigator: Alshimaa Azab, PhD; Cairo University

• PRS Account: Qassim University
• Verification Date: August 2023