Fasciitis, Plantar Clinical Trial
Official title:
Effect of Radiofrequency Treatments on Foot Functionality Index, Patient Satisfaction and Pain Scores in Plantar Fasciitis Patients
NCT number | NCT06426667 |
Other study ID # | 2024/202 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 15, 2024 |
Est. completion date | July 30, 2024 |
In adults, chronic plantar fasciitis stands as the predominant cause of persistent heel discomfort.Usually, individuals depict a pulsating pain concentrated around the point of origin of the plantar fascia on the calcaneus. Numerous randomized and non-randomized studies have demonstrated the effectiveness of radiofrequency as a treatment modality for chronic plantar heel pain.In this study, our objective is to assess the impact of radiofrequency modalities applied to the posterior tibial nerve and/or the calcaneal spur area, guided by ultrasound, on patient satisfaction, pain scores, and functional improvement in individuals with chronic plantar fasciitis
Status | Recruiting |
Enrollment | 108 |
Est. completion date | July 30, 2024 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 18-65 years old, - Heel pain for at least 6 months and a diagnosis of plantar fasciitis confirmed by direct radiography and physical examination, - Visual analog scale is 4 or more - No response to conservative treatment (medical and physical medicine modalities) Exclusion Criteria: - History of trauma or calcaneus fracture, - Osteoarthritis, Diabetes mellitus, chronic heart disease - Presence of pregnancy, - Pain due to peripheral neuropathy or ischemia - Inability to tolerate injections in the heel area, - Allergy to local anesthetics or steroids, - Presence of an open wound on the side of the foot that the injection will be performed - Local or systemic infection at the time of the procedure - Previous steroid injection, radiofrequency application or ESWT (electroshock wave) treatment into the heel - History of surgical intervention to the heel - Presence of any functional limitation in the affected foot - Presence of neurological, hepatic and/or metabolic diseases; dermatological infections, seronegative spondyloarthropathy, bleeding diathesis - Failure to discontinue anticoagulant or antiaggregant within the specified periods - Absence of follow-up throughout the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara University | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara University |
Turkey,
Latt LD, Jaffe DE, Tang Y, Taljanovic MS. Evaluation and Treatment of Chronic Plantar Fasciitis. Foot Ankle Orthop. 2020 Feb 13;5(1):2473011419896763. doi: 10.1177/2473011419896763. eCollection 2020 Jan. — View Citation
Li X, Zhang L, Gu S, Sun J, Qin Z, Yue J, Zhong Y, Ding N, Gao R. Comparative effectiveness of extracorporeal shock wave, ultrasound, low-level laser therapy, noninvasive interactive neurostimulation, and pulsed radiofrequency treatment for treating plantar fasciitis: A systematic review and network meta-analysis. Medicine (Baltimore). 2018 Oct;97(43):e12819. doi: 10.1097/MD.0000000000012819. — View Citation
Orhurhu V, Urits I, Orman S, Viswanath O, Abd-Elsayed A. A Systematic Review of Radiofrequency Treatment of the Ankle for the Management of Chronic Foot and Ankle Pain. Curr Pain Headache Rep. 2019 Jan 19;23(1):4. doi: 10.1007/s11916-019-0745-5. — View Citation
Wu YT, Chang CY, Chou YC, Yeh CC, Li TY, Chu HY, Chen LC. Ultrasound-Guided Pulsed Radiofrequency Stimulation of Posterior Tibial Nerve: A Potential Novel Intervention for Recalcitrant Plantar Fasciitis. Arch Phys Med Rehabil. 2017 May;98(5):964-970. doi: 10.1016/j.apmr.2017.01.016. Epub 2017 Feb 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain severity | pain severity change by using Numeric Rating Scala will be observed before and at 1, 3 months after the procedure.
pain severity change by using Numeric Ratin Scala was observed 3 months after the procedure.The 11-point numerical scale ranges from '0', representing "no pain", to '10', representing extreme pain (e.g., "pain as bad as you can imagine" or "worst pain imaginable"). |
1 and 3 months | |
Primary | Patient satisfaction after the procedure | Patients will evaluate their satisfaction after the procedure as "satisfied", "uncertain" or "not satisfied". | 1 and 3 months | |
Primary | functionallity | Functionality of foot will be observed at before the procedure and 1, 3 months after the procedure. Foot functionalliy index will be used. Foot function index consists of 23 items with 3 subgroups: pain, disability and activity limitation. To calculate the subscales and total score, the scores of each item are summed, divided by the sum of the maximum scores of the items and multiplied by 100. Higher scores indicate more pain, disability, and activity limitation. The survey score varies between 0-100, and as the score increases, the disability increases. | 1 and 3 months | |
Primary | medication use | number of medication use (nonsteroidal anttinflamatort drugs, opioids, muscle relaxants) wiil be evaluated | 1 and 3 months |
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