Turf ToeNCT05982431
Metatarsophalangeal Joint Sprain Kinesiotaping
A study testing Traditional physical therapy program and Kinsio taping in people with Turf Toe and Metatarsophalangeal (Joint) Sprain, run by Qassim University at 2 sites in Saudi Arabia.
Trial summary
kinesio taping would reduce pain, improve gait performance, and enhance the functional capacity of turf toe patients undergoing physical therapy Read more about this study
- Who is it for?
- Ages 25 to 30 years
- Conditions the study is for
- Turf Toe, Metatarsophalangeal (Joint) Sprain
- What is being tested?
- Traditional physical therapy program and Kinsio taping
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 10 Sep 2021to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
Al Kharj, Riyadh Region, 11432
King Khalid Hospital
Al Kharj, Riyadh Region
About this study
Official title: Kinesiology Taping Helps Patients With First Metatarsophalangeal Joint Sprain
kinesio taping would reduce pain, improve gait performance, and enhance the functional capacity of turf toe patients undergoing physical therapy
Read the 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.
- Conditions
- Turf Toe, Metatarsophalangeal (Joint) Sprain
- Being tested
- Traditional physical therapy program, Kinsio taping, placebo Kinsio taping
- Keywords
- turf toe, Metatarsophalangeal Sprain, functional ability, gait parameters, kinesiology taping
- Medical subject headings
- Foot Injuries, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional physical therapy programOther
Also called exercise program
60-minutes exercise program, three times a week on alternate days for 12 successive weeks
Kinsio tapingOther
Also called kinesiology taping
One full strip of kinesiology taping tape and one half-length strip were needed for the kinesiology taping application
placebo Kinsio tapingOther
Also called placebo kinesiology taping
One full strip of kinesiology taping tape and one half-length strip were needed for the placebo kinesiology taping application
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Experimental | 60-minutes exercise program, three times a week on alternate days for 12 successive weeks. Receives: Other: Traditional physical therapy program |
| placebo kinesiology taping plus exercise group | Experimental | 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. Receives: Other: Traditional physical therapy program; Other: placebo Kinsio taping |
| kinesiology taping plus exercise group | Experimental | 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. Receives: Other: Traditional physical therapy program; Other: Kinsio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at first week
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.
Measured: after 12 weeks
Gait parameters (step length by centimeter).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Measured: at first week
Gait parameters (step length by centimeter).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Measured: after 12 weeks
Gait parameters (stride length by meter).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Measured: at first week
Gait parameters (stride length by meter).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Measured: after 12 weeks
Gait parameters (cadence by steps per minute).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Measured: at first week
Gait parameters (cadence by steps per minute).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Measured: after 12 weeks
Gait parameters (velocity by centimeter per second).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Measured: at first week
Gait parameters (velocity by centimeter per second).
The twelve computerized cameras of the VICON 3D motion analysis system were used to record gait data.
Measured: after 12 weeks
Secondary outcomes (2)
Functional ability assessment
Functional ability was assessed using the 6-minute walk test.
Measured: at first week
Functional ability assessment
Functional ability was assessed using the 6-minute walk test.
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start10 Sep 2021
- Primary completion22 Aug 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Turf ToeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Responsible party
- Principal investigator, Maged Basha, Qassim University
- Investigators
- Alshimaa Azab, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982431
- Sponsor's protocol ID
- RHPT/0021/0063
- Status last verified
- Aug 2023
- First submitted
- 10 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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.
PubMed 23306413Burr 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.
PubMed 21673494Kim 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.
PubMed 29158472
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiology Taping Helps Patients With First Metatarsophalangeal Joint Sprain
- ClinicalTrials.gov ID
- NCT05982431
- Acronym / sponsor ID
- RHPT/0021/0063
- Conditions
- Turf Toe, Metatarsophalangeal (Joint) Sprain
- Keywords
- turf toe, Metatarsophalangeal Sprain, functional ability, gait parameters, kinesiology taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| exercise group | Experimental | Other: Traditional physical therapy program60-minutes exercise program, three times a week on alternate days for 12 successive weeks. |
| placebo kinesiology taping plus exercise group | Experimental | Other: Traditional physical therapy program, Other: placebo Kinsio tapingKinesiology taping was used, however the strain was zero. Before each exercise session, the tape was changed every two days while the patients were present. |
| kinesiology taping plus exercise group | Experimental | Other: Traditional physical therapy program, Other: Kinsio tapingputting 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. |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional physical therapy programAlso: exercise program60-minutes exercise program, three times a week on alternate days for 12 successive weeks | Other | exercise group, kinesiology taping plus exercise group, placebo kinesiology taping plus exercise group |
| Kinsio tapingAlso: kinesiology tapingOne full strip of kinesiology taping tape and one half-length strip were needed for the kinesiology taping application | Other | kinesiology taping plus exercise group |
| placebo Kinsio tapingAlso: placebo kinesiology tapingOne full strip of kinesiology taping tape and one half-length strip were needed for the placebo kinesiology taping application | Other | placebo kinesiology taping plus exercise group |
Primary outcome
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.
2 secondary outcomes
Functional ability assessment
Time frame: at first week
Functional ability assessment
Time frame: after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Background: PubMed 23306413Mostafavifar 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.
- Background: PubMed 21673494Burr 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.
- Background: PubMed 29158472Kim 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.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alshimaa Azab, PhD principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional physical therapy program and Kinsio taping in people with Turf Toe and Metatarsophalangeal (Joint) Sprain, run by Qassim University at 2 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain visual analog scale (time frame: at first week). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05982431, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.