Hallux ValgusRCTNCT05165134
Hallux Valgus Conservative Treatment
A study testing Kinesiotape in people with Hallux Valgus, run by University of Jazan at 1 site in Saudi Arabia.
Trial summary
Studying the effect of kinesiotape on hallux valgus angle and pain in hallux valgus patients. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Kinesiotape
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 24 Aug 2020to 15 Nov 2021
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- mobile hallux valgus
Who cannot join
- using orthotics
- knee malalignment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Short-Term Conservative Treatment Using Kinesiotape on Hallux Valgus Angle
Studying the effect of kinesiotape on hallux valgus angle and pain in hallux valgus patients.
Read the detailed description
30 patients (male and female) suffering from bilateral Halux valgus. Divided randomly into 2 groups
- st group receive kinesiotape bilaterally for correction : Hallux valgus angle (HVA) was measured using Xray and pain was measured using VAS before applying tape and after 8 weeks of tape application.
- nd group receive placebo tape bilaterally and had the same measurements.
2 groups were on a group of exercises
- Conditions
- Hallux Valgus
- Being tested
- Kinesiotape
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapeOther
Elastic tape used for mechanical correction of the deformity in study group and placebo in control group
| Study group | Role | What they receive |
|---|---|---|
| Experimental kinesiotape group A | Experimental | Kinesiotape group Receives: Other: Kinesiotape |
| Placebo kinesiotape group B | Placebo comparator | Control group Receives: Other: Kinesiotape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hallux valgus angle (HVA )
Hallux valgus angle measured by x ray
Measured: 8 weeks
Pain on metatarsophalangeal joint measured by visual analogue scale (VAS)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start24 Aug 2020
- Primary completion29 Jan 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pretest and posttest Control group randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohammed Moustafa, University of Jazan
- Investigators
- Mohamed M Ahmed, Principal investigator, Assistant Professor of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165134
- Sponsor's protocol ID
- JU
- Acronym
- RCT
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All will be accessible on request
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Short-Term Conservative Treatment Using Kinesiotape on Hallux Valgus Angle
- ClinicalTrials.gov ID
- NCT05165134
- Acronym / sponsor ID
- RCT / JU
- Conditions
- Hallux Valgus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of JazanOther government
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 21 Dec 2021 (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.
Studying the effect of kinesiotape on hallux valgus angle and pain in hallux valgus patients.
Detailed description
30 patients (male and female) suffering from bilateral Halux valgus. Divided randomly into 2 groups
- st group receive kinesiotape bilaterally for correction : Hallux valgus angle (HVA) was measured using Xray and pain was measured using VAS before applying tape and after 8 weeks of tape application.
- nd group receive placebo tape bilaterally and had the same measurements.
2 groups were on a group of exercises
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pretest and posttest Control group randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Experimental kinesiotape group A | Experimental | Other: KinesiotapeKinesiotape group |
| Placebo kinesiotape group B | Placebo comparator | Other: KinesiotapeControl group |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- mobile hallux valgus
Key exclusion criteria (2 listed)
- using orthotics
- knee malalignment
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 |
|---|---|---|
| KinesiotapeElastic tape used for mechanical correction of the deformity in study group and placebo in control group | Other | Experimental kinesiotape group A, Placebo kinesiotape group B |
Primary outcome
Hallux valgus angle (HVA )
Time frame: 8 weeks
Hallux valgus angle measured by x ray
Pain on metatarsophalangeal joint measured by visual analogue scale (VAS)
Time frame: 8 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 21 Dec 2021.
- Individual participant dataSharing planned: Yes. All will be accessible on request
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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.
Mohamed M Ahmed principal investigator
Assistant Professor of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotape in people with Hallux Valgus, run by University of Jazan at 1 site 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 1 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 21 Dec 2021. 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 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. Some participants in this study may receive a placebo. 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?
Hallux valgus angle (HVA ) (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 21 Dec 2021.