None listed
Conditions
Brief summary
The aim of this study is to assess efficacy of three different therapeutic approaches with use of radial shockwave or high intensity laser in treatment of patients with plantar fasciitis. The main goal of the study is to determine whether therapies with HILT or RSWT combined with HILT are more effective in treatment of patients with plantar fasciitis than RSWT monotherapy. Treatment effectiveness will be rated basing on pain reduction and functional improvement noted on questionnaire prepared for physiotherapeutic examination. To assess pain reduction we will use VAS, NRS and Laitinen scale. Functional improvement in everyday situations will be assessed using a modified WOMAC questionnaire.Patients will be randomly assigned to one of three groups. First group will receive combined therapy of HILT and RSWT. Second group will receive HILT monotherapy and RSWT monotherapy will be applied in the third group. The therapy will be carried out using BTL-5000 SWT Power + High Intensity Laser 12 device. Three applications of RSWT will be made in groups at the painful location with intervals of 5-7 days. HILT will be applied for 6 consecutive working days.Each HILT application will be individually adapted to the size of the foot and will be performed using the labile method in the heel area. Before the therapy, during it and after therapy patient’s pain will be assessed using the VAS scale, Laitinen scale and functional fitness with use of WOMAC questionnaire. The patient's BMI will also be measured to assess correlation between pain relapses and BMI. Control visits will take place after the last therapeutic session and 6 months from the end of therapy, and they will consist of filling all study questionnaires to assess therapy effects.
Interventions
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 ass
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
Sponsors
Witold Rongies
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
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).
Exclusion criteria
1. Age <18 years old 2. Lack of informed consent of the patient to participate in the study. 3. Contraindications to performing physical procedures (eg current or past cancer, pregnancy). 4. Patients with constant cardiac pacing or other implanted electronic implants. 5. The use of other forms of therapy or pharmacotherapy affecting the pain sensation and the state of enthesopathy in the area of the plantar fascia or injection of corticosteroids within 6 months before the examination. 6. Ongoing anticoagulant therapy. 7. Advanced deformities of lower limbs. 8. Lower limb asymmetry exceeding 2 cm. 9. The occurrence of autoimmune diseases.
Outcome results
None listed