NCT02608723

Brief Summary

To check in patients suffering from chronic plantar fasciitis treated with shock wave therapy, if the outward appearance of the device affects clinical outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

June 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

November 13, 2015

Last Update Submit

November 17, 2015

Conditions

Plantar FasciitisPain

Keywords

shock waveplantar fasciitisplacebo effectnocebo effect

Outcome Measures

Primary Outcomes (1)

  • Function of the foot

    FFI (Foot Function Index) questionnaire

    Four months

Secondary Outcomes (5)

  • Pain

    Four months

  • Plantar fascia thickness

    Four months

  • Perception of patient recovery

    Four months

  • Painkillers consumption

    Four months

  • Adverse effects

    Four months

Study Arms (3)

Standard shock waves device

ACTIVE COMPARATOR

3 sessions were applied: one per week.

Device: Standard shock waves device

Austere shock waves device

ACTIVE COMPARATOR

3 sessions were applied: one per week.

Device: Austere shock waves device

Sophisticated shock waves device

ACTIVE COMPARATOR

3 sessions were applied: one per week.

Device: Sophisticated shock waves device

Interventions

Standard shock waves deviceDEVICE

3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device.

Standard shock waves device
Austere shock waves deviceDEVICE

3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device.

Austere shock waves device
Sophisticated shock waves deviceDEVICE

3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device.

Sophisticated shock waves device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than 18 years.
  • Being able to understand the explanations about the potential benefits and risks of study participation.
  • Diagnosis of chronic plantar fasciitis. Proven by clinical examination: Meeting at least 2 of the following criteria:
  • Tenderness in the proximal insertion of the plantar fascia (area of the medial calcaneal tuberosity).
  • Pain during the first steps to get out of bed in the morning and / or after a period of rest time.
  • With a duration of symptoms ≥ 6 months at the time of study entry.
  • Having received conservative therapy without success, at least two treatments. Treatments may have been made isolated, combined or consecutively.

You may not qualify if:

  • Bilateral plantar fasciitis.
  • Hiper/ hypothyroidism.
  • Diabetes mellitus.
  • Treatment with anticoagulants
  • Inflammatory diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Center "Salut i Esport"

Santa Perpètua de Gaià, Barcelona, 08130, Spain

Location

MeSH Terms

Conditions

Fasciitis, PlantarPain

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Antoni Morral, PhDc

    Rehabilitation Center "Salut i Esport"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2015

First Posted

November 20, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

ES(1)