Dataset Information

Intense Therapeutic Ultrasound for Pain Relief in the Treatment for Chronic Plantar Fasciopathy.

ABSTRACT:

Background

Intense therapeutic ultrasound (ITU) is an innovative ultrasound-based therapy where sound waves are concentrated into select musculoskeletal tissue. These focused waves generate thermal coagula at a controlled depth and space while preserving surrounding tissues. A multicenter study was conducted evaluating the efficiency, safety, and patient tolerance of ITU for the treatment of chronic plantar fasciitis (CPF) pain.

Methods

Seventy-four CPF patients, having failed conservative and/or minimally invasive treatment, participated in the study. Randomized participants either received 2 ITU treatments or 2 sham ITU treatments in addition to standard-of-care therapy. Plantar fascia pain was assessed pretreatment and at 4, 8, 12, and 26 weeks after treatment. Diagnostic ultrasonographic images were analyzed to examine hypoechoic, perifascial lesions whose volumes were calculated until week 12. Function and patient satisfaction were measured using self-reported outcome measures.

Results

The treated group reported significant average pain reduction (-26%, -33%, -43%) and hypoechoic lesion volume (-33%, -53%, -68%) at weeks 4, 8, and 12 compared to baseline. Although the control/sham group reported insignificant pain changes at the same time points (-5%, +8%, and +2%) and increased hypoechoic lesion volume (+15%, +28%, +58%). Treated patients reported a significant increase in daily living activities (+28%, +42%, +47%, +40%) compared to the sham/control group (+0.12%, +12%, +3%, +21%). Patient satisfaction remained more than 80% at weeks 8, 12, and 26 for all treatment groups.

Conclusion

ITU is an effective pain relief treatment for CPF, which is refractory to either conservative measures or minimally invasive treatments.

Level of evidence

Level II.

SUBMITTER: Slayton MH

PROVIDER: S-EPMC8696915 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPlantar fasciopathy is the most common reason for complaints of plantar heel pain and one of the most prevalent musculoskeletal conditions with a reported lifetime incidence of 10%. The condition is normally considered self-limiting with persistent symptoms that often last for several months or years. Multiple treatments are available, but no single treatment appears superior to the others. Heavy-slow resistance training and radiofrequency microtenotomy for the treatment of plantar fasciopathy have shown potentially positive effects on short- and long-term outcomes (> 3 months). However, the effect of heavy-slow resistance training compared with a radiofrequency microtenotomy treatment is currently unknown. This trial compares the efficacy of heavy-slow resistance training and radiofrequency microtenotomy treatment with supplemental standardized patient education and heel inserts in improving the Foot Health Status Questionnaire pain score after 6 months in patients with plantar fasciopathy.MethodsIn this randomized superiority trial, we will recruit 70 patients with ultrasound-confirmed plantar fasciopathy and randomly allocate them to one of two groups: (1) heavy-slow resistance training, patient education and a heel insert (n = 35), and (2) radiofrequency microtenotomy treatment, patient education and a heel insert (n = 35). All participants will be followed for 1 year, with the 6-month follow-up considered the primary endpoint. The primary outcome is the Foot Health Status Questionnaire pain domain score. Secondary outcomes include the remaining three domains of the Foot Health Status Questionnaire, a Global Perceived Effect scale, the physical activity level, and Patient Acceptable Symptom State, which is the point at which participants feel no further need for treatment.DiscussionBy comparing the two treatment options, we should be able to answer if radiofrequency microtenotomy compared with heavy-slow resistance training is superior in patients with plantar fasciopathy.Trial registrationClinicalTrials.gov NCT03854682. Prospectively registered on February 26, 2019.