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Trial registered on ANZCTR


Registration number
ACTRN12614000803695
Ethics application status
Approved
Date submitted
15/07/2014
Date registered
29/07/2014
Date last updated
27/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Extracorporeal shock wave therapy in the treatment of tennis elbow
Scientific title
Comparison of focused versus radial extracorporeal shock wave therapy in the treatment of lateral epicondylitis – a randomised controlled trial
Secondary ID [1] 284987 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extracorporeal shock wave therapy in tennis player elbow 292491 0
Physical therapy and sport rehabilitation 292492 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292802 292802 0 0
Other physical medicine / rehabilitation
Musculoskeletal 292924 292924 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 289820 0
Rehabilitation
Comparator / control treatment
Patients without ESWT (placebo with ultrasound probe):
-frequency 1MHz
-dose 0 W/cm2
-constant wave
Each patient will participate in 3 therapeutic sessions (each session will be approximately 45 minutes long) at weekly intervals (the same as in experimental groups)
Control group
Placebo

Outcomes
Primary outcome [1] 292654 0
Level of pain assesed by Visual Analogue Scale (VAS)
Timepoint [1] 292654 0
At the end of therapy sessions and three, six and twelve weeks after therapy
Primary outcome [2] 292724 0
Muscle power assesed by grip strength test
Timepoint [2] 292724 0
At the end of therapy sessions and three, six and twelve weeks after therapy
Secondary outcome [1] 309426 0
Percentage changes in level of pain calculated from equation (difference between initial and final pain divided by initial pain) expressed in percent
Timepoint [1] 309426 0
At the end of therapy sessions and three, six and twelve weeks after therapy
Secondary outcome [2] 309555 0
Percentage changes in muscle power calculated from equation (difference between initial and final muscle power divided by initial muscle power) expressed in percent
Timepoint [2] 309555 0
At the end of therapy sessions and three, six and twelve weeks after therapy

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated to the groups. Computer-generated random numbers will be sealed in sequentially numbered envelopes, and the group allocation be independent of the time and person delivering the treatment. The physician (research coordinator) who will allocate the subjects to groups have envelopes, each containing a piece of paper marked with either group A (focused ESWT) or B (radial ESWT) or C (placebo). The physician will select and openan envelope in the presence of a physiotherapist to see the symbol and then direct the patient to the corresponding group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer and numbered envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis and evaluation of the results will be based on the comparison of intra- and intergroup results. Statistical analysis of these results will be performed by means of the Statistica 10 software, manufactured by StatSoft (licence of Medical University of Silesia). All analysed intergroup variables will be checked with respect to their similarity (uniformity; chi2 NW). A critical significance level a (alpha) = 0.05 or less will be considered statistically significant. For measurable variables (quantitative), arithmetic mean, standard deviations, medians and range of variability (extreme values) will be calculated. For qualitative variables, the frequency of occurrence (percentage) will be calculated. Comparison of intergroup results in order to determine the significance of the achieved differences, will be performed by means of parametric (ANOVA, Student's t-test, Welch's t test) or non-parametric (Mann-Whitney`s and Fischer tests, depending on meeting criteria for the specific test. Correlation of variables in the examined groups will also be checked.

To achieve study objectives the absolute minimal number of participants should be 20 in each group (for non-parametric tests). Smaller number of patients will not be enough from both statistical and clinical point of view (the smaller number of patients is not enough for reliable statistical analysis because of too large standard deviations due to characteristics of patients). However, the most reliable number od patients should be 30 in each comparative group (we will be able to use parametric tests). The reliable number of participants was estimated by Statistica 10 software, manufactured by StatSoft (licence of Medical University of Silesia).

In calculating our sample size we have allowed for:
1. 20% loss to follow up
2. Historical information from our unit that 45% of patients who are offered conservative (standard physical therapy) management for this condition opt for ESWT within 6 months.

This investigation has 95% power to detect a difference between group mean (SD) in the primary outcome pain (VAS) and muscle power of 12 patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2014
Actual
4/08/2014
Date of last participant enrolment
Anticipated
Actual
3/10/2014
Date of last data collection
Anticipated
Actual
23/03/2018
Sample size
Target
90
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 6215 0
Poland
State/province [1] 6215 0

Funding & Sponsors
Funding source category [1] 289602 0
University
Name [1] 289602 0
Medical Universisty of Silesia
Country [1] 289602 0
Poland
Primary sponsor type
University
Name
Medical Universisty of Silesia
Address
Poniatowskiego Street 15, 40-055 Katowice
Country
Poland
Secondary sponsor category [1] 288285 0
None
Name [1] 288285 0
Address [1] 288285 0
Country [1] 288285 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291338 0
The Research Ethics Committee from the Medical University of Silesia in Katowice, Poland
Ethics committee address [1] 291338 0
Poniatowskiego Street 15, 40-055 Katowice
Ethics committee country [1] 291338 0
Poland
Date submitted for ethics approval [1] 291338 0
24/11/2010
Approval date [1] 291338 0
21/12/2010
Ethics approval number [1] 291338 0
KNW/0022KB1/158/10

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49962 0
Prof Andrzej Franek
Address 49962 0
Department of Medical Biophysics, Medical University of Silesia Medykow Street 18, building C2 40 – 752 Katowice, Poland
Country 49962 0
Poland
Phone 49962 0
+48602474583
Fax 49962 0
Email 49962 0
[email protected]
Contact person for public queries
Name 49963 0
Prof Piotr Krol
Address 49963 0
Department of Physiotherapy Basics, Academy School of Physical Education Mikolowska 72 Street 40-065 Katowice, Poland
Country 49963 0
Poland
Phone 49963 0
+4860662898
Fax 49963 0
Email 49963 0
[email protected]
Contact person for scientific queries
Name 49964 0
Prof Piotr Krol
Address 49964 0
Department of Physiotherapy Basics, Academy School of Physical Education Mikolowska 72 Street 40-065 Katowice, Poland
Country 49964 0
Poland
Phone 49964 0
+4860662898
Fax 49964 0
Email 49964 0
[email protected]

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