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To investigate whether a procedure of ultrasound-guided autologous blood injections (ABI), which includes a dry-needling component within the overall procedure, has any measureable clinical benefit over ultrasound-guided dry needling alone in patients with chronic plantar fasciitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Active Comparator | local anaesthetic - lidocaine 1%, dry needling, autologous blood injection, + structured rehab programme |
|
| control group | Placebo Comparator | local anaesthetic - lidocaine 1%, dry needling, + structured rehab programme |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Blood Injection | Other | ultrasound-guided autologous blood injection procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in pain - as assessed by 0-10 VAS scale | 3 & 6 months - primary outcome set at 6 months for study, but using 3 month interim result as well |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in pain / improvement in function - as assessed by several PROMS (as below) | validated PROMs in use in this study include: FFI-r, MOXFQ, FAAM | 3 & 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Wheeler | UHL NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Leicester NHS Trust | Leicester | United Kingdom |
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| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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| ID | Term |
|---|---|
| D000079245 | Dry Needling |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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| Structured rehabilitation programme | Other | (this intervention is given to patients in both arms of the study) - a standardised structured rehabilitation programme of home exercises that the patient is instructed on how to start, and how to progress during the study period |
|
| dry needling injection | Other | (this intervention is given to patients in both arms of the study) - ultrasound-guided dry needling injection performed under ultrasound guidance |
|