MetatarsalgiaNCT02578615
Physiotherapy for Chronic Metatarsalgia
An observational study of Metatarsalgia, run by Spiraldynamik AG.
Trial summary
The pilot study was conducted in the form of an open prospective single-arm observational study with 28 patients who received physiotherapy at the Spiraldynamik® Med Center in Zurich. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Metatarsalgia
- What is being tested?
- physiotherapy
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Sep 2014
- Phase
- Observational
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic metatarsalgia
Who may be able to join
- main diagnosis: Metatarsalgia
- secondary diagnosis: Hallux rigidus,Hallux valgus, Knick-Senk-Spreizfuß, Hohlfuß
- age 30-75 Jahre, gender both
- chronic ( ≥ 3 month),
- pain ≥ 1 visuell analog scale (VAS)
- no other complementary therapy
Who cannot join
- local: trauma, fracture, tumore, infectionen
- pain after forefoot - operation
- neurological diseases
- generell: somatoform, pension covet
About this study
Official title: Physiotherapie Bei Chronischer Metatarsalgie - Ein Vergleich Klinischer Parameter Vor Und Nach Therapie gemäß Spiraldynamik®- Konzept
The pilot study was conducted in the form of an open prospective single-arm observational study with 28 patients who received physiotherapy at the Spiraldynamik® Med Center in Zurich.
Read the detailed description
The pilot study was conducted in the form of an open prospective single-arm observational study. The data of 28 patients who received physiotherapy at the Spiraldynamik® Med Center in Zurich was evaluated. The endpoints of Visual Analog Scale Foot and Ankle (VAS FA), Activity Index (AI), plantar and inter-metatarsal pres-sure pain, rearfoot angle and dorsal extension capability of the upper ankle joint were individually compared and analyzed before and after therapy.
- Conditions
- Metatarsalgia
- Being tested
- physiotherapy
- Medical subject headings
- Metatarsalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyOther
physiotherapeutic intervention according to the principles of the Spiraldynamik® concept
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale Foot and Ankle (VAS FA)
Measured: 9 weeks
Secondary outcomes (4)
Activity Index (AI)
Measured: 3, 8 weeks
plantar and inter-metatarsal pressure pain - measured dichotom
measured dichotom - pain triggered or not
Measured: 9 weeks
rearfoot angle measured in degree °
measured in degree, during standing: the angle for pes valgus (measured at the position of calcaneus)
Measured: 9 weeks
dorsal extension capability of the upper ankle joint measured in degree °
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startDec 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetatarsalgiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spiraldynamik AG
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Albers, Gertraud, Spiraldynamik AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578615
- Sponsor's protocol ID
- 2014-0528
- Status last verified
- Oct 2015
- First submitted
- 13 Oct 2015
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapie Bei Chronischer Metatarsalgie - Ein Vergleich Klinischer Parameter Vor Und Nach Therapie gemäß Spiraldynamik®- Konzept
- ClinicalTrials.gov ID
- NCT02578615
- Acronym / sponsor ID
- 2014-0528
- Conditions
- Metatarsalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Spiraldynamik AGUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Oct 2015 (estimated)
- 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 pilot study was conducted in the form of an open prospective single-arm observational study with 28 patients who received physiotherapy at the Spiraldynamik® Med Center in Zurich.
Detailed description
The pilot study was conducted in the form of an open prospective single-arm observational study. The data of 28 patients who received physiotherapy at the Spiraldynamik® Med Center in Zurich was evaluated. The endpoints of Visual Analog Scale Foot and Ankle (VAS FA), Activity Index (AI), plantar and inter-metatarsal pres-sure pain, rearfoot angle and dorsal extension capability of the upper ankle joint were individually compared and analyzed before and after therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic metatarsalgia
Key inclusion criteria (6 listed)
- main diagnosis: Metatarsalgia
- secondary diagnosis: Hallux rigidus,Hallux valgus, Knick-Senk-Spreizfuß, Hohlfuß
- age 30-75 Jahre, gender both
- chronic ( ≥ 3 month),
- pain ≥ 1 visuell analog scale (VAS)
Key exclusion criteria (4 listed)
- local: trauma, fracture, tumore, infectionen
- pain after forefoot - operation
- neurological diseases
- generell: somatoform, pension covet
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 |
|---|---|---|
| physiotherapyphysiotherapeutic intervention according to the principles of the Spiraldynamik® concept | Other | – |
Primary outcome
Visual Analog Scale Foot and Ankle (VAS FA)
Time frame: 9 weeks
4 secondary outcomes
Activity Index (AI)
Time frame: 3, 8 weeks
plantar and inter-metatarsal pressure pain - measured dichotom
Time frame: 9 weeks
rearfoot angle measured in degree °
Time frame: 9 weeks
dorsal extension capability of the upper ankle joint measured in degree °
Time frame: 9 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 19 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Metatarsalgia, run by Spiraldynamik AG.
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 6 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 19 Oct 2015. 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?
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?
Visual Analog Scale Foot and Ankle (VAS FA) (time frame: 9 weeks). 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 19 Oct 2015.