Effectiveness of extracorporeal shock wave therapy in patients with proximal plantar fasciitis
| ISRCTN | ISRCTN49594569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49594569 |
| Secondary identifying numbers | N/A |
- Submission date
- 02/07/2009
- Registration date
- 18/09/2009
- Last edited
- 27/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Hongying Chen
Scientific
Scientific
ST833
The Hong Kong Polytechnic University
Hong Kong
-
China
Study information
| Study design | Double-blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details provided in the interventions section below to request a patient information sheet |
| Scientific title | Changes of proximal plantar fascia microcirculation after extracorporeal shock wave therapy in patients with proximal fasciitis: a double blinded randomised controlled trial |
| Study objectives | 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(s) | Ethical Committee of the Hong Kong Polytechnic University, 18/06/2009, ref: HSEARS20090618004 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2009 |
| Completion date | 01/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 68 |
| Key inclusion criteria | 1. Aged between 18 and 60 years (either sex) 2. Suffered from proximal heel pain for more than 3 months |
| Key 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 |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 01/09/2011 |
Locations
Countries of recruitment
- China
Study participating centre
ST833
Hong Kong
-
China
-
China
Sponsor information
The Hong Kong Polytechnic University (China)
University/education
University/education
c/o Dr Amy Fu
ST 533
Department of Rehabilitation Sciences
Hong Kong
-
China
| Website | http://www.polyu.edu.hk/ |
|---|---|
"ROR" |
https://ror.org/0030zas98 |
Funders
Funder type
University/education
The Hong Kong Polytechnic University (China) - Department of Rehabilitation Sciences
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2013 | Yes | No |
