Condition category
Musculoskeletal Diseases
Date applied
02/07/2009
Date assigned
18/09/2009
Last edited
27/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Hongying Chen

ORCID ID

Contact details

ST833
The Hong Kong Polytechnic University
Hong Kong
-
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Changes of proximal plantar fascia microcirculation after extracorporeal shock wave therapy in patients with proximal fasciitis: a double blinded randomised controlled trial

Acronym

Study hypothesis

1. There will be an increase in microcirculation at the proximal plantar fascia (PPF) in chronic plantar fasciitis patients
2. Short term and long term changes no microcirculation can be observed after application of extracorporeal shock wave therapy

Ethics approval

Ethical Committee of the Hong Kong Polytechnic University, 18/06/2009, ref: HSEARS20090618004

Study design

Double-blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details provided in the interventions section below to request a patient information sheet

Condition

Chronic plantar fasciitis

Intervention

Patients will be randomised by drawing cards to receive 3 or 6 sessions of radial extracorporeal shock wave therapy (ESWT) treatment (Storz Medical, Duolith SD, Switzerland), or no active treatment (control). The outcome measures will be taken before, immediately after, at 3, 6 and 12 months after intervention.

Contact details for patient information sheet:
Dr Fu Siu Ngor
The Hong Kong Polytechnic University
Rm ST533, Yuk Choi Road
Hung Hom, Kowloon
Hong Kong
Tel: +852 27666726
Email: rsamyfu@polyu.edu.hk

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Microcirculation index, measured before, immediately after, at 3, 6 and 12 months after intervention

Secondary outcome measures

1. Plantar fascia thickness, measured before and 6 and 12 months after intervention
2. Ankle range of motion, measured before and 6 and 12 months after intervention
3. Foot Function Index, measured before, immediately after, at 3, 6 and 12 months after intervention
4. Visual Analogue Scale (VAS), measured before and 6 and 12 months after intervention

Overall trial start date

01/09/2009

Overall trial end date

01/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 and 60 years (either sex)
2. Suffered from proximal heel pain for more than 3 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

68

Participant exclusion criteria

1. Surgery in the treatment area
2. Peripheral vessel diseases
3. Diabetes mellitus
4. Peripheral neuropathy
5. Foot fracture
6. Ankle sensation loss

Recruitment start date

01/09/2009

Recruitment end date

01/09/2011

Locations

Countries of recruitment

China

Trial participating centre

ST833
Hong Kong
-
China

Sponsor information

Organisation

The Hong Kong Polytechnic University (China)

Sponsor details

c/o Dr Amy Fu
ST 533
Department of Rehabilitation Sciences
Hong Kong
-
China

Sponsor type

University/education

Website

http://www.polyu.edu.hk/

Funders

Funder type

University/education

Funder name

The Hong Kong Polytechnic University (China) - Department of Rehabilitation Sciences

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23886626

Publication citations

  1. Results

    Chen H, Ho HM, Ying M, Fu SN, Association between plantar fascia vascularity and morphology and foot dysfunction in individuals with chronic plantar fasciitis., J Orthop Sports Phys Ther, 2013, 43, 10, 727-734, doi: 10.2519/jospt.2013.4774.

Additional files

Editorial Notes