Hallux ValgusNCT01952691
Initial Effects of Kinesiotaping in Non Surgical Treatment of Hallux Valgus
A study testing kinesiotaping in people with Hallux Valgus and Pain, run by Hacettepe University.
Trial summary
The main aim of this study was to find the initial effects of kinesiotaping on pain and joint alignment used in the conservative treatment of hallux valgus. 22 female patients diagnosed with hallux valgus participated in this study. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Hallux Valgus, Pain
- What is being tested?
- kinesiotaping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Hallux adduction angle between 15-40º
- Pain intensity higher than 5 according to VAS
- 20- 45 years age female
- No trauma, surgery history
- Surgery is indicated but the patient is willing to try conservative treatment options
Who cannot join
- Fracture, surgery history on the great toe
- Systematic disease (Rheumatoid Arthritis, Systematic Lupus Erythematosus Diabetes)
- Using NSAID, analgesic drug
- Hallux rigidus diagnosis
About this study
Official title: Initial Effects of Kinesiotaping in Conservative Treatment of Hallux Valgus
The main aim of this study was to find the initial effects of kinesiotaping on pain and joint alignment used in the conservative treatment of hallux valgus.
22 female patients diagnosed with hallux valgus participated in this study. Kinesiotaping was implemented after the first assessment and renewed in the 3rd, 7th and 10th days. The main outcome measures were the pain hallux adduction angle. Kinesiotaping may be an effective treatment option in decreasing pain and deformity in hallux valgus deformity who are conservatively treated. In future studies this method might be shown in larger sample groups at longer periods of treatment comparing with alternative treatment approaches like exercise or orthotics.
Read the detailed description
Hallux valgus is a common pathologic entity affecting the great toe. Taping is an alternative method used to treat hallux valgus. The main aim of this study was to find the initial effects of kinesiotaping on pain and joint alignment used in the conservative treatment of hallux valgus.
22 female patients diagnosed with 13 bilateral, 7 right, 2 left totally 35 with hallux valgus participated in this study. Kinesiotaping was implemented after the first assessment and renewed in the 3rd, 7th and 10th days. The main outcome measures were the change in pain was assessed by using Visual Analogue Scale (VAS) and hallux adduction angle was measured by the universal goniometry. Secondary outcome measures were Patients' functional status was measured by Foot Function Index (FFI) and AOFAS. The plain radiographic results were also measured before and after 1-month of treatment.
Pain and disability was controlled by KinesioTape® implementation in patients with hallux valgus. Kinesiotaping may be an effective treatment option in decreasing pain and deformity in hallux valgus deformity who are conservatively treated. In future studies this method might be shown in larger sample groups at longer periods of treatment comparing with alternative treatment approaches like exercise or orthotics.
- Conditions
- Hallux Valgus, Pain
- Being tested
- kinesiotaping
- Keywords
- hallux valgus, pain, conservative, treatment
- Medical subject headings
- Hallux Valgus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiotapingDevice
correction method was used to align hallux.
| Study group | Role | What they receive |
|---|---|---|
| kinesiotaping | Experimental | all patients were implemented a kinesiotaping to align the hallux to correct position Receives: Device: kinesiotaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adduction Angle of Hallux With X RAY
X ray was obtained in non-weight bearing sitting position. It's aimed to see the treatment effects kinesio taping
Measured: up to 30 days after the treatment
Secondary outcomes (2)
FFI
We aimed to see the change in functional status with FFI (Foot function index) scale The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales used to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it required help) that best describes the patients' foot over the past week. Patients were instructed to mark a VAS score for each question. The total score was calculated using only the questions answered.
Measured: baseline, on the 3rd, 7th, 10th and 30th days during the treatment
Adduction Angle
we aimed to see the change in hallux valgus angle during treatment.
Measured: baseline and 30th days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startMar 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GulOznur KARABICAK, Hacettepe University
- Investigators
- nilgun bek, Phd PT, Study director, Hacettepe UniversityUgur TIFTIKCI, MD, Study chair, beypazari hospitalGul Oznur KARABICAK, MS PT, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952691
- Sponsor's protocol ID
- HEK 10/58-48
- Status last verified
- Apr 2015
- First submitted
- 19 Sep 2013
- Last updated
- 14 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Effects of Kinesiotaping in Conservative Treatment of Hallux Valgus
- ClinicalTrials.gov ID
- NCT01952691
- Acronym / sponsor ID
- HEK 10/58-48
- Conditions
- Hallux Valgus, Pain
- Keywords
- hallux valgus, pain, conservative, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Posted 6 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study was to find the initial effects of kinesiotaping on pain and joint alignment used in the conservative treatment of hallux valgus.
22 female patients diagnosed with hallux valgus participated in this study. Kinesiotaping was implemented after the first assessment and renewed in the 3rd, 7th and 10th days. The main outcome measures were the pain hallux adduction angle. Kinesiotaping may be an effective treatment option in decreasing pain and deformity in hallux valgus deformity who are conservatively treated. In future studies this method might be shown in larger sample groups at longer periods of treatment comparing with alternative treatment approaches like exercise or orthotics.
Detailed description
Hallux valgus is a common pathologic entity affecting the great toe. Taping is an alternative method used to treat hallux valgus. The main aim of this study was to find the initial effects of kinesiotaping on pain and joint alignment used in the conservative treatment of hallux valgus.
22 female patients diagnosed with 13 bilateral, 7 right, 2 left totally 35 with hallux valgus participated in this study. Kinesiotaping was implemented after the first assessment and renewed in the 3rd, 7th and 10th days. The main outcome measures were the change in pain was assessed by using Visual Analogue Scale (VAS) and hallux adduction angle was measured by the universal goniometry. Secondary outcome measures were Patients' functional status was measured by Foot Function Index (FFI) and AOFAS. The plain radiographic results were also measured before and after 1-month of treatment.
Pain and disability was controlled by KinesioTape® implementation in patients with hallux valgus. Kinesiotaping may be an effective treatment option in decreasing pain and deformity in hallux valgus deformity who are conservatively treated. In future studies this method might be shown in larger sample groups at longer periods of treatment comparing with alternative treatment approaches like exercise or orthotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| kinesiotaping | Experimental | Device: kinesiotapingall patients were implemented a kinesiotaping to align the hallux to correct position |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Hallux adduction angle between 15-40º
- Pain intensity higher than 5 according to VAS
- 20- 45 years age female
- No trauma, surgery history
- Surgery is indicated but the patient is willing to try conservative treatment options
Key exclusion criteria (4 listed)
- Fracture, surgery history on the great toe
- Systematic disease (Rheumatoid Arthritis, Systematic Lupus Erythematosus Diabetes)
- Using NSAID, analgesic drug
- Hallux rigidus diagnosis
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 |
|---|---|---|
| kinesiotapingcorrection method was used to align hallux. | Device | kinesiotaping |
Primary outcome
Adduction Angle of Hallux With X RAY
Time frame: up to 30 days after the treatment
X ray was obtained in non-weight bearing sitting position. It's aimed to see the treatment effects kinesio taping
2 secondary outcomes
FFI
Time frame: baseline, on the 3rd, 7th, 10th and 30th days during the treatment
Adduction Angle
Time frame: baseline and 30th days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
nilgun bek, Phd PT study director
Hacettepe University
Ugur TIFTIKCI, MD study chair
beypazari hospital
Gul Oznur KARABICAK, MS PT principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing kinesiotaping in people with Hallux Valgus and Pain, run by Hacettepe University.
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 4 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 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 6 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adduction Angle of Hallux With X RAY (time frame: up to 30 days after the treatment). 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 14 Mar 2016.