NCT02578615

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
Last Updated

October 19, 2015

Status Verified

October 1, 2015

Enrollment Period

9 months

First QC Date

October 13, 2015

Last Update Submit

October 15, 2015

Conditions

Metatarsalgia

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale Foot and Ankle (VAS FA)

    9 weeks

Secondary Outcomes (4)

  • Activity Index (AI)

    3, 8 weeks

  • plantar and inter-metatarsal pressure pain - measured dichotom

    9 weeks

  • rearfoot angle measured in degree °

    9 weeks

  • dorsal extension capability of the upper ankle joint measured in degree °

    9 weeks

Interventions

physiotherapyOTHER

physiotherapeutic intervention according to the principles of the Spiraldynamik® concept

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with chronic metatarsalgia

You may qualify if:

  • 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

You may not qualify if:

  • local: trauma, fracture, tumore, infectionen
  • pain after forefoot - operation
  • neurological diseases
  • generell: somatoform, pension covet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metatarsalgia

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Foot DiseasesMusculoskeletal DiseasesJoint DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 19, 2015

Study Start

December 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 19, 2015

Record last verified: 2015-10