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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23886626
Publication citations
-
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.