None listed
Conditions
Brief summary
Management of tennis elbow is a significant and difficult medical problem. Common interventions include rest, inelastic proximal forearm strap (functional brace) and analgesia, non-steroidal anti-inflammatory drugs, corticosteroid injections, and surgery. Literature to substantiate these show that limited evidence supports the efficacy of drugs and surgical procedures, which are reported to have small effect sizes and only relieve pain in the short term. Current physiotherapy treatments, including extensor eccentric strengthening and progressive resistance exercise program, transverse friction massage, Cyriax and Mills manipulation, ultrasound, electrical stimulation and iontophoresis, low-dose laser therapy may provide short term pain relief but show minimal benefit over rest and advice in the medium to long term, making this a less cost effective treatment option. Modern, well-documented and promising methods from physical therapy are needed, as extracorporeal shock wave therapy. Radial ESWT is generated by pneumatic devices, which produce linear pressure with low energy values. The main role in radial ESWT plays the special cartridge that is located inside the generator. The energy is produced by the pressure wave, while compressed air starts accelerate the cartridge which strikes at the top of the applicator. The energy generated by the pressure wave is absorbed into the skin deep and spread with a widen beam to the larger target area. Focused ESWT is generated by electromagnetic, electrohydraulic, and piezoelectric sources. Pressure pulses arise rapidly in range of 10-100 MPa and concentrate the acoustic energy beam in narrower target area with a penetration depth - muscle and fascia tissues.Based on a Medline and Pubmed database search and on a review of key journals, no previous study had been conducted to compare these two modalities of lateral epicondylitis treatment.
Interventions
The objective of this study is to assess the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) and to compare focused versus radial extracorporeal shock wave therapy in the treatment of tennis elbow. The primary study endpoints will be an analysis of pain relief change and functional improvement inside all groups of patients (comparison before and after therapy inside each group) The secondary endpoint will be a follow-up observation (3, 6 and 12 weeks after the end of the study - compar
The objective of this study is to assess the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) and to compare focused versus radial extracorporeal shock wave therapy in the treatment of tennis elbow. The primary study endpoints will be an analysis of pain relief change and functional improvement inside all groups of patients (comparison before and after therapy inside each group) The secondary endpoint will be a follow-up observation (3, 6 and 12 weeks after the end of the study - comparison between both groups). Intervention: Patients from group A will receive a focused shockwave therapy utilising the Wolf Piezowave device without anaesthesia. The lateral epicondyle will receive a total of 2000 shocks during a session (4 Hz; 0.2 mJ/mm2). Each patient will have 3 sessions (each session will be approximately 45 minutes long) at weekly intervals. Radial shock wave therapy making use of the Gymna Uniphy ShockMaster 500 will be applied to patients form group B also without anaesthesia. In the first stage of treatment, the lateral epicondyle will receive 2000 shocks (8 Hz, 2.5 bars). In the second stage, 2000 shocks will be applied to the dorsal part of the forearm with the same frequency and pressure. Each patient will participate in 3 therapeutic sessions (each session will be approximately 45 minutes long) at weekly intervals. Measurements: Before and after treatment, as well as 3, 6 and 12 weeks later, all patients will be evaluated: - for the level of pain with a Visual Analogue Scale (VAS) - for the average strength muscle with a grip strength using a SH5001 dynamometer
Sponsors
Medical Universisty of Silesia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participating subjects will meet the following inclusion criteria: (1) pain feelings of the tenis elbow within at least 1 month, (2) painful palpation of the lateral epicondyle (3) painful resisted middle finger and wrist extension (Thomson test).
Exclusion criteria
Patients will be excluded if they (1) younger than 18 years, (2) have a local infection, (3) malignancy, (4) bilateral tennis elbow, (5) carpal tunnel syndrome, (6) medial epicondylitis, (7) elbow arthritis or instability, (8) generalised polyarthritis, (9) ipsilateral shoulder dysfunction, (10) neurological abnormalities, (11) radial-nerve entrapment, (12) cardiac arrhythmia or a pacemaker, (13) cancer, (14) diabetes, (15) have received a physical therapy and/or corticosteroid injection within the previous six weeks or (16) are pregnant.
Outcome results
None listed