None listed
Conditions
Brief summary
The presence of Achilles tendinopathy significantly impairs patients' quality of life, prompting them to seek effective treatment. The aim of the study is to determine and compare the effectiveness of combined radial shock wave therapy and local vibration (experimental group) versus radial shock wave therapy alone (control group). Forty patients will be randomly assigned to one of the study groups. To objectively assess the effects of therapy, the following measurements will be conducted before the start of the therapy and at 1 and 6 weeks after its completion: biomechanical gait assessment of the patient on a treadmill, pain threshold assessment using a dolorimeter, evaluation of resting pain, pain during physical activity, and nocturnal pain using the Numeric Rating Scale, and functional assessment of patients using the VISA-A questionnaireand a modified Laitinen questionnaire.
Interventions
Local Vibration
Local vibration treatments will be performed using the Storz Medical Duolith SD1 device with the V25 vibration transmitter (Ø 25 mm). In patients with significant body hair, the skin surface where the treatment will be applied will be covered with gel prior to the procedure.
The patient will be positioned lying prone with a bolster placed under the ankles. The foot will be positioned in dorsiflexion. During the treatment, both bellies of the gastrocnemius muscle will be dynamic
Local Vibration Local vibration treatments will be performed using the Storz Medical Duolith SD1 device with the V25 vibration transmitter (Ø 25 mm). In patients with significant body hair, the skin surface where the treatment will be applied will be covered with gel prior to the procedure. The patient will be positioned lying prone with a bolster placed under the ankles. The foot will be positioned in dorsiflexion. During the treatment, both bellies of the gastrocnemius muscle will be dynamically stimulated. The following parameters will be applied: Vibration frequency: 30 Hz Pressure: 3 bar Number of vibrations: 2,000 (Hyo Jeong 2023) Number of sessions: 3 (with a 7-day interval between sessions) Radial Shock Wave Therapy Radial shock wave treatments will be performed without anesthesia. Prior to the procedure, the patient's skin surface at the treatment site will be covered with gel. The patient will be positioned lying prone with a bolster placed under the ankles. The foot will be maintained in dorsiflexion. During the treatment, the entire Achilles tendon will be treated by slowly moving the applicator along the lateral, dorsal, and medial sides of the tendon. The following parameters will be applied: Pressure: 3 bar Number of impulses: 2,000 Frequency: 10 Hz Number of sessions: 3 (with a 7-day interval between sessions) Local vibration therapy will be administered first, followed by the application of radial shockwave therapy. The intervention will be performed by a qualified physiotherapist. The entire therapeutic session, including local vibration treatment and radial shockwave therapy, will last approximately 15 minutes. To ensure fidelity and adherence to the intended procedures, a standardized intervention protocol will be implemented. The physiotherapist involved in the study will undergo training prior to the intervention to ensure consistency in the delivery of treatment. The intervention sessions will take place at the Department of Physical Medicine at the Jerzy Kukuczka Academy of Physical Education in Katowice.
Sponsors
Jerzy Kukuczka Academy of Physical Education in Katowice
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Informed consent to participate in the study Age between 18 and 45 years Symptoms persisting for at least 3 months Mid-portion Achilles tendinopathy (symptoms located 2 to 6 cm proximal to the tendon’s insertion on the calcaneus) Tendon changes visible on ultrasound imaging (presence of focal hypoechoic areas, vascular abnormalities, or localized swelling) Recreationally active patients (aerobic activity for 80 minutes at moderate intensity once or twice a week)
Exclusion criteria
Insertional Achilles tendinopathy (when pathological changes involve the distal part of the tendon at its attachment to the posterior aspect of the calcaneal tuberosity) Age under 18 years Pregnancy Thrombophlebitis Atherosclerosis Renal failure Local infection in the lower limb Cancer Previous surgery on the Achilles tendon Knee joint instability Ankle joint instability Leg length discrepancy Dermatitis of the lower limb Anticoagulant therapy Physical therapy within the last 6 weeks Corticosteroid injections within the last 6 weeks Type I or insulin-treated Type II diabetes Rheumatoid arthritis and other rheumatic diseases Pacemaker Cardiac arrhythmias Heart failure Patellar tendon enthesopathy Bilateral Achilles tendinopathy History of stroke (ischemic or hemorrhagic) Acute post-traumatic condition Hypersensitivity to shock wave therapy Cemented prosthesis Tumor Vascular fragility Osteoporosis Epilepsy
Outcome results
None listed