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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02578615
Other study ID # 2014-0528
Secondary ID
Status Completed
Phase N/A
First received October 13, 2015
Last updated October 15, 2015
Start date December 2013
Est. completion date September 2014

Study information

Verified date October 2015
Source Spiraldynamik AG
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 75 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- local: trauma, fracture, tumore, infectionen

- pain after forefoot - operation

- neurological diseases

- generell: somatoform, pension covet

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
physiotherapy
physiotherapeutic intervention according to the principles of the Spiraldynamik® concept

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Spiraldynamik AG

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale Foot and Ankle (VAS FA) 9 weeks No
Secondary Activity Index (AI) 3, 8 weeks No
Secondary plantar and inter-metatarsal pressure pain - measured dichotom measured dichotom - pain triggered or not 9 weeks No
Secondary rearfoot angle measured in degree ° measured in degree, during standing: the angle for pes valgus (measured at the position of calcaneus) 9 weeks No
Secondary dorsal extension capability of the upper ankle joint measured in degree ° 9 weeks No
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