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Trial registered on ANZCTR


Registration number
ACTRN12618000744257
Ethics application status
Approved
Date submitted
8/03/2018
Date registered
3/05/2018
Date last updated
3/04/2019
Date data sharing statement initially provided
3/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of high intensity laserotherapy in calcaneal spur- analysis of short and further results
Scientific title
The effect of high intensity laserotherapy and ultrasounds therapy on the level of pain perception associated with heel spur
Secondary ID [1] 294225 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Calcaneal spur 306887 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305985 305985 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
60 patients with diagnosis of calcaneal spurs (basic group and placebo) intend to acquire research. Therapy will take place in the Clinical Research Laboratory at the State Medical University of Applied Sciences in Opole.
In the research project, it is planned to create 2 homogeneous comparative groups, using the principles of randomization patients will be assigned to particular groups:
• Group 1: the study (n = 30) will be administered in the form of 15 treatment sessions using a high-energy laser and standard therapy in the case of heel spur, it is ultrasounds (UD). Each treatment will be characterized by a contact method using labile movements in the area of the greatest pain.
HILT parameters: 7W, dose 149.9J / cm2, time 11 minutes and 53 seconds, spot applicator with 30cm2 cone breaker, wavelength 1064 nm (GaAlAs laser), 90% duty cycle, total energy 4496.
Treatments will be carried out 5 times a week for a period of 3 weeks with the need to maintain continuity of therapy (excluding weekends).
In order to follow the methodology of the scientific project, patients will be asked to sign up for the attendance list. The results will be saved on the patient's card and a computer file.
One physical therapist with 2 years of experience will deliver each treatment in each group
Intervention code [1] 300518 0
Rehabilitation
Comparator / control treatment
Group 2: control (n = 30) will be treated using ultrasound and sham surgery in the case of HILT. The parameters of the UD procedure will be the same as in Group 1, while performing a laser therapy, the therapist will only perform head movement while maintaining the principles of methodology that apply.
UD treatment parameters: 0.8W / cm2, 5 minutes at 1 MHz, filling factor 100%. Treatments will be carried out 5 times a week for a period of 3 weeks with the need to maintain continuity of therapy (excluding weekends).
Control group
Placebo

Outcomes
Primary outcome [1] 305022 0
The foot function index has been used to measure the pathology of the foot function in terms of pain, disability and activity limitations.The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales.
Timepoint [1] 305022 0
Primary endpoint: after 3 months
Before and after therapy sessions and follow-up after 1 month
Primary outcome [2] 305517 0
Stabilometric Platform analysis the position of posture with open and closed eyes (COP).
Timepoint [2] 305517 0
Primary endpoint: after 3 months
Before and after therapy sessions and follow-up after 1 month
Secondary outcome [1] 343904 0
The Laitinen scale was used for subjective assessment of the level of pain. The patient evaluated four indicators: pain severity, passenger frequencies, frequency of using analgesics, limitations of physical activity.
Each of the points is assigned points from 0 to 4, where 0 means no solution and the maximum problem is 4.
Timepoint [1] 343904 0
At baseline, after the last intervention and follow-up after 1 month and 3 months
Secondary outcome [2] 343905 0
Level of pain assesed by Visual Analogue Scale (VAS) in which the patient assesses the experienced pain on a simple scale from 0 to 10, where 0 denotes lack of pain and 10 denotes the strongest pain.
Timepoint [2] 343905 0
At baseline, after the last intervention and follow-up after 1 month and 3 months

Eligibility
Key inclusion criteria
- diagnosed heel spur,
- adult person,
- current X-ray examination,
- participants suffering from pain for at least 3 months with no prior physical therapy for at least 3 months prior to the study and an unsuccessful treatment using non-steroidal anti-inflammatory drugs (NSAID).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- heart stimulator,
- cancer, pregnancy,
- implants from foreign bodies in the area of applicationlaser radiation,
- no pain,
- skin diseases,
- application area,
- acute infections,
- blood clotting disorders, arrhythmias and conduction disorders heart,
- other foot disorders,
- mental disorder, abolished or disturbed feeling,
- lack of cooperation.

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)
Allocation will be done by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a 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
Not Applicable
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The obtained results will be subjected to statistical analysis made with the STATISTICA software. Power analysis in each group will be required and calculated to establish the statistical significance with a = 0.05 and power = 0.80 based on the estimated outcomes of 85% for therapeutic method. For measurable variables, the arithmetic mean, standard deviation, medians and extreme values (minimum and maximum) will be calculated. However for qualitative variables, the occurrence rates, will be expressed as a percentage. Homogeneity of the compared groups will be established in terms of selected characteristics of the participants, and the level of significance will be accepted at p>0.05. Results will be compared between the groups with comparative tests (independent), as well as each group results obtained before and after therapy (dependent tests). The type of statistical tests will be depend on the fulfilment of their objectives. Statistically significant differences at p<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9647 0
Poland
State/province [1] 9647 0

Funding & Sponsors
Funding source category [1] 298860 0
University
Name [1] 298860 0
Opole Medical School
Address [1] 298860 0
Department of Physiotherapy
Katowicka 68
45-060 Opole, Poland
Country [1] 298860 0
Poland
Primary sponsor type
University
Name
Opole Medical School, Department of Physiotherapy
Address
Opole Medical School
Department of Physiotherapy
Katowicka 68
45-060 Opole, Poland
Country
Poland
Secondary sponsor category [1] 298071 0
None
Name [1] 298071 0
Address [1] 298071 0
Country [1] 298071 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299806 0
Commission of Bioethics at Wroclaw Medical University
Ethics committee address [1] 299806 0
Pasteura Street 1, 50-367 Wroclaw
Ethics committee country [1] 299806 0
Poland
Date submitted for ethics approval [1] 299806 0
Approval date [1] 299806 0
18/01/2018
Ethics approval number [1] 299806 0
KB-795/2017

Summary
Brief summary
The aim of the research project will be to observe the obtained results of therapy using high energy laser therapy and ultrasound. Conducting studies on a uniform, randomized group of patients, with an analogous development statistical analysis in accordance with the guidelines of evidence-based medicine (EBM), will help to answer questions about the effectiveness of treatments in a given disease unit. Research using a high-energy laser will be characterized by a high degree of innovation. To document the obtained results, it is planned to use non-invasive methods of measurement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81618 0
Dr Piotr Tkocz
Address 81618 0
Opole Medical School
Department of Physiotherapy
Katowicka 68
45-060 Opole
Country 81618 0
Poland
Phone 81618 0
+48 791 665 683
Fax 81618 0
Email 81618 0
tkoczp@wsm.opole.pl
Contact person for public queries
Name 81619 0
Dr Piotr Tkocz
Address 81619 0
Opole Medical School
Department of Physiotherapy
Katowicka 68
45-060 Opole
Country 81619 0
Poland
Phone 81619 0
+48 791 665 683
Fax 81619 0
Email 81619 0
tkoczp@wsm.opole.pl
Contact person for scientific queries
Name 81620 0
Prof Jakub Taradaj
Address 81620 0
Academy of Physical Education, Department of Physical Therapy
Mikolowska 72A street
40-065 Katowice
Country 81620 0
Poland
Phone 81620 0
+48 322 075 318
Fax 81620 0
Email 81620 0
j.taradaj@awf.katowice.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results