Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000593235
Ethics application status
Approved
Date submitted
4/02/2018
Date registered
17/04/2018
Date last updated
11/12/2018
Date data sharing statement initially provided
11/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Extracorporeal shock wave therapy in the treatment of low back pain
Scientific title
Long and short term results of extracorporeal shock wave therapy in the treatment of low back pain: clinical effects and postural stability analysis
Secondary ID [1] 293956 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 306456 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305545 305545 0 0
Other physical medicine / rehabilitation
Musculoskeletal 305546 305546 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 verum (2000 pneumatic shocks during a 20 minutes session of 5 Hz; 0.1 mJ/mm2; 2.5 bars) to sham procedure in the treatment of low back pain. The primary study endpoints will be an analysis of pain relief change and functional improvement in two groups of patients (within and intergroup comparison before and after therapy). The secondary endpoints will be a follow-up observation (1 and 3 months after the end of the study - within and intergroup comparisons).

Intervention:
Patients from group A will receive a focused shockwave therapy utilising the radial type pneumatic device without anaesthesia. The intervention will occur in the clinician's office and be administered by certified physiotherapist. The low back area will receive a total of 2000 shocks during a session (5 Hz; 0.1 mJ/mm2; 2.5 bars). Each patient will have 10 sessions (twice a week) within 5 weeks. Patients from group B will receive a sham therapy (the probe will generate a sound signal, but the treatment parameters will be zeroed and the device will be turned off with a display system in "standby mode"). In addition, all patients will be supplemented with physical exercises performed throughout the therapy period. A single series will last 45 minutes daily and will be carried out five times a week (Monday to Friday). Stabilization training will include:
- techniques for the relaxation of the myofascial system on erector spinae muscle;
- techniques for activating the neutral position of the lumbo-pelvic-hip complex and deep muscles;
- stimulation of proper breathing and correct activation of the transverse abdominal muscle;
- coordination of superficial and deep muscles activation;
- postural and dynamic training.
The physical exercises will occur "one-on-one" method in the gym part of clinician's office and be administered by certified athletic therapist. The training will be with the participants' intensity of 65-75% maximal heart rate (to monitor the application of exercises and the participants' status; the therapist observation diary will be kept).
Intervention code [1] 300219 0
Rehabilitation
Intervention code [2] 300220 0
Treatment: Devices
Comparator / control treatment
Patients without ESWT (placebo with sham probe):
-shocks 2000 impulses
-dose 0 mJ/mm2
-frequency 5 Hz
Additionally, participants will complete the physical exercises Monday to Friday throughout the 5 weeks (the same as in experimental group).
Control group
Placebo

Outcomes
Primary outcome [1] 304678 0
Pain assessed used the Visual-Analogue Scale (VAS)
Timepoint [1] 304678 0
Baseline, weeks 5, 8 (primary endpoint) and 12.
Primary outcome [2] 304856 0
Quality of life assessed used the Roland–Morris Disability Questionnaire (RMDQ).
Timepoint [2] 304856 0
Baseline, weeks 5, 8 (primary endpoint) and 12.
Primary outcome [3] 304857 0
Postural stability assessed used the double-plate stabilometric platform compatible with a computer-aided posturographic system model CQ Stab 2P.
Timepoint [3] 304857 0
Baseline, weeks 5, 8 (primary endpoint) and 12..
Secondary outcome [1] 343385 0
None
Timepoint [1] 343385 0
None

Eligibility
Key inclusion criteria
Participants with lumbosacral discopathy and chronic pain syndrome with pseudo-radicular radiation without neurological impairment that have never had any prior spinal surgical intervention will be included in the study. The diagnosis of LBP will be based on MRI scans, which allow to clearly show the advancement of degenerative changes at the L5-S1 spine segment (the inclusion criterion was at least the 3rd grade in the Modic classification).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria will be: (1) acute and subacute spine pain episodes (up to 6 months), (2) radicular pain syndrome, (3) degenerative changes on other segments of the spine (only initial, uncomplicated radiological changes (i.e., the 1st or the 2nd grade were allowed according to the Modic classification), (4) past fractures within the spine, (5) tumors and hyperplastic changes, (6) spondylolisthesis, (7) rheumatic diseases, (8) cauda equina syndrome, (9) pregnancy in case of women, (10) chronic heart failure and peripheral vascular disease, (11) arrhythmia and implanted pacemaker, (12) implanted metal implants, (13) skin diseases in the area of shock wave treatment, (14) superficial or deep sensory impairment, (15) mental disorders and addictions, (16) cancer, (17) psoriasis and other immunological diseases, (18) infections, (19) antibiotics and any analgesic, anti-inflammatory, or antithrombotic agent, (20) damage of the vestibular system, (21) inflammation of the vestibular neuron or vestibulocochlear nerve disorder, (22) Meniere's disease, (23) dysfunction of the inner ear, and other (24) diseases of the cerebellum, spinal cord, and brainstem.

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 randomized with equal probability to ESWT or sham using a central computer-generated random allocation . Subjects will be randomised in order of entry into the study. The group allocation will be independent of the time and person delivering the treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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 12 software, manufactured by StatSoft (licence of Medical University of Wroclaw). 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 10 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 12 software, manufactured by StatSoft.

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.

The level a=0.05 was assumed for all analyses. Based on type I error, probability set at 0.05, with 90% power, detection of statistically significant differences between both groups required at least 10 patients in each group (total of 20 participants).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/04/2018
Actual
23/04/2018
Date of last participant enrolment
Anticipated
Actual
6/08/2018
Date of last data collection
Anticipated
15/10/2018
Actual
19/11/2018
Sample size
Target
20
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 9554 0
Poland
State/province [1] 9554 0

Funding & Sponsors
Funding source category [1] 298584 0
University
Name [1] 298584 0
Public Higher Medical Professional School
Country [1] 298584 0
Poland
Primary sponsor type
Individual
Name
Tomasz Halski
Address
Public Higher Medical Professional School,
68 Katowicka St,
45-060 Opole
Country
Poland
Secondary sponsor category [1] 297739 0
Individual
Name [1] 297739 0
Joanna Rosinczuk
Address [1] 297739 0
Wroclaw Medical University,
5 Bartla St,
51-618 Wroclaw
Country [1] 297739 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299549 0
The Research Ethics Committee from the Wroclaw Medical University
Ethics committee address [1] 299549 0
Ethics committee country [1] 299549 0
Poland
Date submitted for ethics approval [1] 299549 0
09/01/2017
Approval date [1] 299549 0
07/02/2017
Ethics approval number [1] 299549 0
KB-75/2017

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80814 0
Prof Jakub Taradaj
Address 80814 0
Faculty of Physiotherapy,
Public Higher Medical Professional School,
68 Katowicka St, 45-060 Opole
Country 80814 0
Poland
Phone 80814 0
+48668613945
Fax 80814 0
Email 80814 0
[email protected]
Contact person for public queries
Name 80815 0
Karolina Walewicz
Address 80815 0
Faculty of Physiotherapy,
Public Higher Medical Professional School,
68 Katowicka St, 45-060 Opole
Country 80815 0
Poland
Phone 80815 0
+48790715393
Fax 80815 0
Email 80815 0
[email protected]
Contact person for scientific queries
Name 80816 0
Karolina Walewicz
Address 80816 0
Faculty of Physiotherapy,
Public Higher Medical Professional School,
68 Katowicka St, 45-060 Opole
Country 80816 0
Poland
Phone 80816 0
+48790715393
Fax 80816 0
Email 80816 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
That is new for our team. We did not consider...


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.