Assessment of the effectiveness of the radial shock wave and high energy laser in patients with plantar fascia enthesopathy. .A randomized clinical trial.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: This was a randomized study designed to assess the efficacy different therapeutic approaches with use High Intensity Laser Therapy (Group 2) (HILT) or combined therapy of Radial Shockwave (RSWT) and High Intensity Laser (Group 3). The therapy will be carried out in accordance with the treatment methodology for a given group with the use of the BTL‐5000 SWT Power + High Intensity Laser 12 apparatus, which enables the performance of radial shock wave and high‐energy laser treatments. Patients assigned to group 2 will receive HILT analgesic program (power of 7,00W and energy dose of 120 J/cm2) and biostimulation program (power of 10,0 W and energy dose 12 J/cm2) applied for 6 consecutive working days with with a one‐day break between sessions. All patients assigned to group 3 will receive therapy consisting of 5 sessions of RSWT (in 5–7‐day intervals) directed at their plantar side of heel. All sessions involved 2,000 shockwaves impulses with 10 Hz frequency and pressure of 2.5 bars applied to the painful site with continuous movements of the applicator, including the 5 second focus on trigger points indicated by the patients on palpation. Prior to RSWT, patients in group 3 received analgesic dose of HILT, with continuous movements of the laser applicator, including 5‐second pauses at the most painful sites. Each HILT session used a power of 10 W and an energy dose of 12 J/cm2, with the treatment area adjusted to the extent of patients pain. Laser therapy and radial shockwave interventions will deliver by registered physiotherapist CONDITION: Musculoskeletal ‐ Other muscular and skeletal disorders Physical Medicine / Rehabilitation ‐ Physiotherapy subjects with plantar fasciitis ; ; subjects with plantar fasciitis PRIMARY OUTCOME: Assessment of RSWT, HILT and combined therapy of RSWT and HILT on pain intensity on visual analogue scale (VAS); ; ; [There are 3 timepoints for pain intensity assessment. 1st ‐ Prior to therapy, 2nd ‐ 1 day up to 7 days after therapy, 3rd ‐ after 6 months after therapy. Additionally, pain intensity assessment will be done after each therapeutic session including RSWT (group 1 and 3)] Primary outcome 2:Assessment of RSWT, HILT and combined therapy of RSWT and HILT on pain intensity on Laitinen’s pain questionnaire[pain intensity assessment. 1st ‐ Prior to therapy, 2nd ‐ 1 day up to 7 days after therapy, 3rd ‐ after 6 months after therapy. Additionally, pain intensity assessment will be done after each therapeutic session including RSWT (group 1 and 3)] Primary outcome 3: Assessment of RSWT, HILT and combined therapy of RSWT and HILT on pain intensity on numerical rating scale (NRS).[pain intensity assessment. 1st ‐ Prior to therapy, 2nd ‐ 1 day up to 7 days after therapy, 3rd ‐ after 6 months after therapy. Additionally, pain intensity assessment will be done after each therapeutic session including RSWT (group 1 and 3)] INCLUSION CRITERIA: 1. Participants may be aged 18 years or older, yet younger than 90 years old. 2. Informed consent of the patient to participate in the study. 3. No contraindications to physiotherapy. 4. Diagnostic Image result (X‐ray or ultrasound or MRI or CT) confirming the presence of enthesopathy in the plantar fascia. 5. Absence of any form of treatment for plantar fascia enthesopathy in the 6 months prior to enrollment in the study. 6. Feeling of pain associated with enthesopathy of the plantar fascia from 5 to 10 on the VAS scale (Visual Analogue Scale). SECONDARY OUTCOME: ; Assessment of RSWT, HILT and combined therapy of RSWT and HILT on pain frequency on Laitinen questionnaire. ; [There are 3 timepoints for functional capabilities assessment. 1 ‐ Prior to therapy, 2 ‐ 1 day up to 7 days after therapy, 3‐ after 6 months after therapy. Additionally, pain intensity assessment will be done after each therapeutic session including RSWT (group 1 and 3)] Assessment of RSWT, HILT and combination therapy of ESWT and HILT for painkillers consumption based on the Laitinen questionnaire. ; Assessment of pain frequency and frequency of taking painkillers on Laitinen questionnaire. ; .[There are 3 timepoints for functional capabilities assessment. 1 ‐ Prior to therapy, 2 ‐ 1 day up to 7 days after therapy, 3‐ after 6 months after therapy. Additionally, pain intensity assessment will be done after each therapeutic session including RSWT (group 1 and 3)] Assessment of RSWT, HILT and combined therapy of RSWT and HILT on the state of selected functional capabilities of the foot in the subjects based on the modified WOMAC questionnaire ; ; ; [There are 3 timepoints for functional capabilities assessment. 1 ‐ Prior to therapy, 2 ‐ 1 day up to 7 days after therapy, 3‐ after 6 months after therapy. Additionally, pain intensity assessment will be done after each therapeutic session including RSWT (group 1 and 3)] Secondary outcome 2: Assessment of RSWT, HILT and combined therapy ofRSWT and HILT on activity on Laitinen questionnaire. [There are 3 timepoints for functional capabilities assessment. 1 ‐ Prior to therapy, 2 ‐ 1 day up to 7 days after therapy, 3‐ after 6 months after therapy. Additionally, pain intensity assessment will be done after each therapeutic session including RSWT (group 1 and 3)]
Epistemonikos ID: 84ccb2c10f0402def9c5dd09db318b0aaa1598dd
First added on: Aug 26, 2024