Posterior Tibial Tendon InsufficiencyNCT03363074
Low-Level Laser Therapy and Orthotic Insole in Tibialis Posterior Tendon Insufficiency
A study testing Orthotic Insole and Low-Level Laser in people with Posterior Tibial Tendon Insufficiency, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare low-level laser therapy and insole interventions on pain, function and muscle strength in subjects with posterior tendon insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Posterior Tibial Tendon Insufficiency
- What is being tested?
- Orthotic Insole and Low-Level Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2017to 5 Sep 2018
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Taking the diagnosis of stage 1 - 2 tibialis posterior insufficiency by the physician,
- Be between the ages of 18 and 60,
- The absence of a different orthopedic or neurological disease that may affect the lower extremity biomechanics,
- Not having a systemic disease that keeps feet.
- Having not received any treatment from the foot area in the last 1 year.
Who cannot join
- Having lower extremity discrepancy more than 1 centimeter (cm),
- Having no ambulation without help.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eastern Mediterranean University
Mersin, Famagusta, 99450
About this study
Official title: Comparison of the Effects of Low-Level Therapy Laser and Orthotic Insole on Pain, Function and Muscle Strength in Subjects With Stage 1-2 Tibialis Posterior Tendon Insufficiency: Randomized Study
The purpose of this study is to compare low-level laser therapy and insole interventions on pain, function and muscle strength in subjects with posterior tendon insufficiency.
Read the detailed description
Purpose of the research; stage 1-2 tibialis between the ages of 18-60 is a comparison of low-level laser therapy and orthotic insole on pain, function and muscle strength in subjects with posterior tendon insufficiency.
Type of research:
This study is a randomized comparative intervention study.
Place to do research:
The study will be carried out in the Prosthetic Orthotics and Biomechanics Center of the Department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences of the Eastern Mediterranean University.
Evoluotion and Sample Size Of Research:
Subjects aged 18-60 who volunteered by the physician from Eastern Mediterranean University who had been diagnosed with tibialis posterior insufficiency would be included in the study.According to the power analysis using G-Power program; a total of 52 subjects will be included in the calculation of Cohen d = 0.8, α = 0.05, β = 0.20, assuming that the nonparametric Mann Whitney-U test is used for comparison between the two groups. It was decided that 60 people would be taken from the survey without a 20% loss.
Volunteers Including / Exploring Criteria:
Inclusion Criteria:
- Taking the diagnosis of stage 1 - 2 tibialis posterior insufficiency by the physician,
- Be between the ages of 18 and 60,
- The absence of a different orthopedic or neurological disease that may affect the lower extremity biomechanics,
- Not having a systemic disease that keeps feet. Having not received any treatment from the foot area in the last 1 year.
Exclusion Criteria:
- Having lower extremity discrepancy more than 1 centimeter (cm),
- Having no ambulation without help.
Reserch Method:
Our study consists of two groups and the subjects will be taken to these groups using a random number table. One group of our study is a and orthotic insole group and the other group is a low -level laser therapy group. The orthotic insole group will use their special insoles for 8 weeks. The low-level laser therapy group will receive treatment at the Prosthesis Orthotic Biomechanics Center of the Eastern Mediterranean University three times a week for 5 weeks. Laser will be applied along the tibial posterior tendon. Before the data is collected, the individual will be informed about the equipment to be used in the tests. There will be 1 trial before assessment and treatment so that participants can become familiar with the equipment. All assessments and insoles will be applied by the same physiotherapist.
Data Collection Vehicles and Properties:
To be applied to the patient:
1.Pain Assessment ; with digital algometer 2.Muscle strength assessment ; with Isokinetic Dynamometer 3.Evulation of Foot Function ; with Foot Function Index 4.Other Assessment ; Foot Posture Index, International Physical Activity Index(short form)
- Pain Assessment ; It will be assessed with pain algometer. Before starting treatment, measurements will be taken at three different points of the tibialis posterior tendon. Three measurements from each point will be taken. The right and left foot will be evaluated. the previously assessed regions will be reevaluated at the end of the treatment.
- Muscle strength assessment Using the isokinetic dynamometer (Humac Norm Isocynetic Dynanometer), the force values of the inverter and the evertor muscles of the foot will be measured.Before starting the test, a standard warm-up program will be applied for 3 minutes without resistance in the patient bicycle ergometer. At the same time, passive stretching of the patients' gastrocnemius and soleus muscles. Subjects movements will be evaluated at 10 repetitions at 180º / sec, 10 repetitions at a rate of 240º / sec. Before each angular velocity, subjects are allowed to perform 3 repeated trials and after 10 seconds rest, tests will be applied. Unilateral measurement will be performed.
- Evulation of Foot Function ; with Foot Function Index. This scale evaluates the severity of foot pain in different situations. It consists of 3 subtitles and contains 23 questions in total. Turkish version adaptation study is done, valid and reliable measure. Each question takes between 0 and 10 points. the total score is divided by the number of questions answered and scaled by finding the value over 100.
- Other Assessment;
- Foot Postüre Index : Index will be used to determine the flat foot of the individuals. According to the scale, a total score of -12 to +12 is obtain with a score under six headings during static standing. Medial longitudinal arch height increases with increasing points, medial longitudinal height decreases with increasing points. Our study will include individuals who have received a minimum score of +6 as in similar research.
- International Physical Activity Index (short form) (IPAQ) : The index will be used to determine the physical activity levels of individuals. With the scale of Turkish validity and reliability studies, low, medium and high intensity activity periods of the individuals in the last week will be evaluated under 7 questions and the average energy expenditure value will be obtained in kcal / week.Individuals will be asked to do this questionnaire on a regular basis every week.
Treatment Program:
Low-level Laser Therapy Group; A low density laser with a power density of 0.05-0.10 (w / cm2), a therapeutic dose of 0.7-7 (j / cm 2) of gallium-arsenic 904 nm will be applied. It will be administered 3 times a week for 5 weeks. Laser treatment will be applied along the tibialis posterior tendon. 3 different point applications will be done. Proximal tibial tendon, distally tibial tendon and medial malleoli posterior.
Orthotic Insole Group:
Individuals will be operated by pressing on a fixed pedobarograph (Medilogic, platform basic, Germany) embedded in a 5-m wooden floor and foot pressure measurements will be taken. Of the three successful measurements made, the one closest to the normal walk will be recorded. According to the foot pressure measurement, the MLA, TA and MTK attachments will be used in the insoles design developed by the modeling program.
The individual will use the insoles for 8 weeks with the appropriate footwear. individuals will be required to fill in the international physical activity scale each week. As well as how many hours a day each of his or her inviduals have been using their insoles. A table will be created and given to the individuals to write how many hours they are using.
- Conditions
- Posterior Tibial Tendon Insufficiency
- Being tested
- Orthotic Insole, Low-Level Laser
- Keywords
- Low-Level Laser Therapy, Orthotic Insoles
- Medical subject headings
- Posterior Tibial Tendon Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthotic InsoleDevice
A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole,and 3mm,15 Shore A hardness ethyl vinyl acetate was used for covering.Orthotic insoles have been emplemented in a pair of sports shoes.
Low-Level LaserDevice
A low density laser with a power density of 0.05-0.10 (w / cm2), a therapeutic dose of 0.7-7 (j / cm 2) of gallium-arsenic 904 nm will be applied. It will be 3 administered times a week for 5 weeks. Laser treatment will be applied along the tibialis posterior tendon. 3 different point (proximal tibial tendon, distally tibial tendon and posterior medial malleol) applications will be done.
| Study group | Role | What they receive |
|---|---|---|
| Orthotic Insole | Experimental | Device: Orthotic Insole 8-week follow-up with Orthotic Insole Receives: Device: Orthotic Insole |
| Low-level Laser Therapy | Experimental | Low-Level Laser 5-week follow-up Receives: Device: Low-Level Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Foot Function Assesed With Foot Function Index
This scale evaluates the severity of foot pain in different situations. It consists of 3 subtitles and contains 23 questions in total. Turkish version adaptation study is done, valid and reliable measure. The total score obtained by the patient between 0-10 of each question was scaled by obtaining a score of 100 with the number of answered questions
Measured: Baseline and 6 week for Low-Level Laser Therapy Group - 8 week for Orthotic Insole Group
Secondary outcomes (2)
Change in Muscle Strength Assesed With Humac Norm Isocynetic Dynanometer
The force values of the inverter and the evertor muscles of the foot will be measured. Before starting the test, a standard warm-up program will be applied for 3 minutes without resistance in the patient bicycle ergometer. At the same time, passive stretching of the patient's gastrocnemius and soleus muscles. Subjects movements will be evaluated at 10 repetitions at 180º / sec, 10 repetitions at a rate of 240º / sec. Before each angular velocity, subjects are allowed to perform 3 repeated trials and after 10 seconds rest, tests will be applied. Unilateral measurement will be performed.
Measured: Basline and 6 week for Low-Level Laser Therapy Group - 8 week for Orthotic Insole Group
Change in Foot Pain Assesed With Digital Algometer
The pain from the three different points of the tendon with the sensor will be assessed. 3 different point (proximal tibial tendon, distally tibial tendon and posterior medial malleol.
Measured: Baseline and 6 week for Low-Level Laser Therapy Group - 8 week for Orthotic Insole Group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start20 Nov 2017
- Primary completion25 Aug 2018
- Study completion5 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Tibial Tendon InsufficiencyStudies 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Koltak, Eastern Mediterranean University
- Investigators
- Yasin Yurt, PhD, Principal investigator, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363074
- Sponsor's protocol ID
- ETK00-2017-0204
- Status last verified
- Nov 2018
- First submitted
- 30 Nov 2017
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Low-Level Therapy Laser and Orthotic Insole on Pain, Function and Muscle Strength in Subjects With Stage 1-2 Tibialis Posterior Tendon Insufficiency: Randomized Study
- ClinicalTrials.gov ID
- NCT03363074
- Acronym / sponsor ID
- ETK00-2017-0204
- Conditions
- Posterior Tibial Tendon Insufficiency
- Keywords
- Low-Level Laser Therapy, Orthotic Insoles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 25 Aug 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 6 Dec 2017 (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.
The purpose of this study is to compare low-level laser therapy and insole interventions on pain, function and muscle strength in subjects with posterior tendon insufficiency.
Detailed description
Purpose of the research; stage 1-2 tibialis between the ages of 18-60 is a comparison of low-level laser therapy and orthotic insole on pain, function and muscle strength in subjects with posterior tendon insufficiency.
Type of research:
This study is a randomized comparative intervention study.
Place to do research:
The study will be carried out in the Prosthetic Orthotics and Biomechanics Center of the Department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences of the Eastern Mediterranean University.
Evoluotion and Sample Size Of Research:
Subjects aged 18-60 who volunteered by the physician from Eastern Mediterranean University who had been diagnosed with tibialis posterior insufficiency would be included in the study.According to the power analysis using G-Power program; a total of 52 subjects will be included in the calculation of Cohen d = 0.8, α = 0.05, β = 0.20, assuming that the nonparametric Mann Whitney-U test is used for comparison between the two groups. It was decided that 60 people would be taken from the survey without a 20% loss.
Volunteers Including / Exploring Criteria:
Inclusion Criteria:
- Taking the diagnosis of stage 1 - 2 tibialis posterior insufficiency by the physician,
- Be between the ages of 18 and 60,
- The absence of a different orthopedic or neurological disease that may affect the lower extremity biomechanics,
- Not having a systemic disease that keeps feet. Having not received any treatment from the foot area in the last 1 year.
Exclusion Criteria:
- Having lower extremity discrepancy more than 1 centimeter (cm),
- Having no ambulation without help.
Reserch Method:
Our study consists of two groups and the subjects will be taken to these groups using a random number table. One group of our study is a and orthotic insole group and the other group is a low -level laser therapy group. The orthotic insole group will use their special insoles for 8 weeks. The low-level laser therapy group will receive treatment at the Prosthesis Orthotic Biomechanics Center of the Eastern Mediterranean University three times a week for 5 weeks. Laser will be applied along the tibial posterior tendon. Before the data is collected, the individual will be informed about the equipment to be used in the tests. There will be 1 trial before assessment and treatment so that participants can become familiar with the equipment. All assessments and insoles will be applied by the same physiotherapist.
Data Collection Vehicles and Properties:
To be applied to the patient:
1.Pain Assessment ; with digital algometer 2.Muscle strength assessment ; with Isokinetic Dynamometer 3.Evulation of Foot Function ; with Foot Function Index 4.Other Assessment ; Foot Posture Index, International Physical Activity Index(short form)
- Pain Assessment ; It will be assessed with pain algometer. Before starting treatment, measurements will be taken at three different points of the tibialis posterior tendon. Three measurements from each point will be taken. The right and left foot will be evaluated. the previously assessed regions will be reevaluated at the end of the treatment.
- Muscle strength assessment Using the isokinetic dynamometer (Humac Norm Isocynetic Dynanometer), the force values of the inverter and the evertor muscles of the foot will be measured.Before starting the test, a standard warm-up program will be applied for 3 minutes without resistance in the patient bicycle ergometer. At the same time, passive stretching of the patients' gastrocnemius and soleus muscles. Subjects movements will be evaluated at 10 repetitions at 180º / sec, 10 repetitions at a rate of 240º / sec. Before each angular velocity, subjects are allowed to perform 3 repeated trials and after 10 seconds rest, tests will be applied. Unilateral measurement will be performed.
- Evulation of Foot Function ; with Foot Function Index. This scale evaluates the severity of foot pain in different situations. It consists of 3 subtitles and contains 23 questions in total. Turkish version adaptation study is done, valid and reliable measure. Each question takes between 0 and 10 points. the total score is divided by the number of questions answered and scaled by finding the value over 100.
- Other Assessment;
- Foot Postüre Index : Index will be used to determine the flat foot of the individuals. According to the scale, a total score of -12 to +12 is obtain with a score under six headings during static standing. Medial longitudinal arch height increases with increasing points, medial longitudinal height decreases with increasing points. Our study will include individuals who have received a minimum score of +6 as in similar research.
- International Physical Activity Index (short form) (IPAQ) : The index will be used to determine the physical activity levels of individuals. With the scale of Turkish validity and reliability studies, low, medium and high intensity activity periods of the individuals in the last week will be evaluated under 7 questions and the average energy expenditure value will be obtained in kcal / week.Individuals will be asked to do this questionnaire on a regular basis every week.
Treatment Program:
Low-level Laser Therapy Group; A low density laser with a power density of 0.05-0.10 (w / cm2), a therapeutic dose of 0.7-7 (j / cm 2) of gallium-arsenic 904 nm will be applied. It will be administered 3 times a week for 5 weeks. Laser treatment will be applied along the tibialis posterior tendon. 3 different point applications will be done. Proximal tibial tendon, distally tibial tendon and medial malleoli posterior.
Orthotic Insole Group:
Individuals will be operated by pressing on a fixed pedobarograph (Medilogic, platform basic, Germany) embedded in a 5-m wooden floor and foot pressure measurements will be taken. Of the three successful measurements made, the one closest to the normal walk will be recorded. According to the foot pressure measurement, the MLA, TA and MTK attachments will be used in the insoles design developed by the modeling program.
The individual will use the insoles for 8 weeks with the appropriate footwear. individuals will be required to fill in the international physical activity scale each week. As well as how many hours a day each of his or her inviduals have been using their insoles. A table will be created and given to the individuals to write how many hours they are using.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthotic Insole | Experimental | Device: Orthotic InsoleDevice: Orthotic Insole 8-week follow-up with Orthotic Insole |
| Low-level Laser Therapy | Experimental | Device: Low-Level LaserLow-Level Laser 5-week follow-up |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Taking the diagnosis of stage 1 - 2 tibialis posterior insufficiency by the physician,
- Be between the ages of 18 and 60,
- The absence of a different orthopedic or neurological disease that may affect the lower extremity biomechanics,
- Not having a systemic disease that keeps feet.
- Having not received any treatment from the foot area in the last 1 year.
Key exclusion criteria (2 listed)
- Having lower extremity discrepancy more than 1 centimeter (cm),
- Having no ambulation without help.
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 |
|---|---|---|
| Orthotic InsoleA computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole,and 3mm,15 Shore A hardness ethyl vinyl acetate was used for covering.Orthotic insoles have been emplemented in a pair of sports shoes. | Device | Orthotic Insole |
| Low-Level LaserA low density laser with a power density of 0.05-0.10 (w / cm2), a therapeutic dose of 0.7-7 (j / cm 2) of gallium-arsenic 904 nm will be applied. It will be 3 administered times a week for 5 weeks. Laser treatment will be applied along the tibialis posterior tendon. 3 different point (proximal tibial tendon, distally tibial tendon and posterior medial malleol) applications will be done. | Device | Low-level Laser Therapy |
Primary outcome
Change in Foot Function Assesed With Foot Function Index
Time frame: Baseline and 6 week for Low-Level Laser Therapy Group - 8 week for Orthotic Insole Group
This scale evaluates the severity of foot pain in different situations. It consists of 3 subtitles and contains 23 questions in total. Turkish version adaptation study is done, valid and reliable measure. The total score obtained by the patient between 0-10 of each question was scaled by obtaining a score of 100 with the number of answered questions
2 secondary outcomes
Change in Muscle Strength Assesed With Humac Norm Isocynetic Dynanometer
Time frame: Basline and 6 week for Low-Level Laser Therapy Group - 8 week for Orthotic Insole Group
Change in Foot Pain Assesed With Digital Algometer
Time frame: Baseline and 6 week for Low-Level Laser Therapy Group - 8 week for Orthotic Insole Group
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 6 Nov 2018.
- Individual participant dataSharing planned: No
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.
Yasin Yurt, PhD principal investigator
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthotic Insole and Low-Level Laser in people with Posterior Tibial Tendon Insufficiency, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
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 2 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Change in Foot Function Assesed With Foot Function Index (time frame: Baseline and 6 week for Low-Level Laser Therapy Group - 8 week for Orthotic Insole Group). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2018.