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Trial registered on ANZCTR


Registration number
ACTRN12622001510730
Ethics application status
Approved
Date submitted
31/05/2022
Date registered
5/12/2022
Date last updated
5/12/2022
Date data sharing statement initially provided
5/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of the effectiveness of the radial shock wave and high energy laser in patients with plantar fascia enthesopathy. .A randomized clinical trial.
Scientific title
The effect of radial shockwave and high intensity laser therapy on pain levels in patients with plantar fasciosis.
Secondary ID [1] 306687 0
none
Universal Trial Number (UTN)
U1111-1275-7353
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
subjects with plantar fasciitis 325632 0
Condition category
Condition code
Musculoskeletal 322989 322989 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 322990 322990 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This was a randomized study designed to assess the efficacy different therapeutic approaches with use High Intensity Laser Therapy (Group 2) (HILT) or combined therapy of Radial Shockwave (RSWT) and High Intensity Laser (Group 3).
The therapy will be carried out in accordance with the treatment methodology for a given group with the use of the BTL-5000 SWT Power + High Intensity Laser 12 apparatus, which enables the performance of radial shock wave and high-energy laser treatments.
Patients assigned to group 2 will receive HILT analgesic program (power of 7,00W and energy dose of 120 J/cm2) and biostimulation program (power of 10,0 W and energy dose 12 J/cm2) applied for
6 consecutive working days with with a one-day break between sessions.
All patients assigned to group 3 will receive therapy consisting of 5 sessions of RSWT (in 5–7-day intervals) directed at their plantar side of heel. All sessions involved 2,000 shockwaves impulses with 10 Hz frequency and pressure of 2.5 bars applied to the painful site with continuous movements of the applicator, including the 5 second focus on trigger points indicated by the patients on palpation. Prior to RSWT, patients in group 3 received analgesic dose of HILT, with continuous movements of the laser applicator, including 5-second pauses at the most painful sites. Each HILT session used a power
of 10 W and an energy dose of 12 J/cm2, with the treatment area adjusted to the extent of patients pain.
Laser therapy and radial shockwave interventions will deliver by registered physiotherapist
Intervention code [1] 323142 0
Rehabilitation
Intervention code [2] 324807 0
Treatment: Other
Comparator / control treatment
Control group (Group 1), received RSWT consisting of 5 therapeutic sessions of (in 5–7-day intervals) directed at their plantar side of heel. All sessions involved 2,000 shockwaves impulses with 10 Hz frequency and pressure of 2.5 bars applied to the painful site with continuous movements of the applicator, including the 5 second focus on trigger points indicated by the patients on palpation. RSWT will be carried out with the use of the BTL-5000 SWT Power + High Intensity Laser 12 apparatus.
Control group
Active

Outcomes
Primary outcome [1] 330770 0
Assessment of RSWT, HILT and combined therapy of RSWT and HILT on pain intensity on visual analogue scale (VAS)
Timepoint [1] 330770 0
There are 3 timepoints for pain intensity assessment. 1st - Prior to therapy, 2nd - 1 day up to 7 days after therapy, 3rd - after 6 months after therapy. Additionally, pain intensity assessment will be done after each therapeutic session including RSWT (group 1 and 3)
Primary outcome [2] 333259 0
Primary outcome 2:Assessment of RSWT, HILT and combined therapy of RSWT and HILT on pain intensity on Laitinen’s pain questionnaire
Timepoint [2] 333259 0
pain intensity assessment. 1st - Prior to therapy, 2nd - 1 day up to 7 days after therapy, 3rd - after 6 months after therapy. Additionally, pain intensity assessment will be done after each therapeutic session including RSWT (group 1 and 3)
Primary outcome [3] 333260 0
Primary outcome 3: Assessment of RSWT, HILT and combined therapy of RSWT and HILT on pain intensity on numerical rating scale (NRS).
Timepoint [3] 333260 0
pain intensity assessment. 1st - Prior to therapy, 2nd - 1 day up to 7 days after therapy, 3rd - after 6 months after therapy. Additionally, pain intensity assessment will be done after each therapeutic session including RSWT (group 1 and 3)
Secondary outcome [1] 407507 0
Assessment of RSWT, HILT and combined therapy of RSWT and HILT on the state of selected functional capabilities of the foot in the subjects based on the modified WOMAC questionnaire
Timepoint [1] 407507 0
There are 3 timepoints for functional capabilities assessment. 1 - Prior to therapy, 2 - 1 day up to 7 days after therapy, 3- after 6 months after therapy. Additionally, pain intensity assessment will be done after each therapeutic session including RSWT (group 1 and 3)
Secondary outcome [2] 416383 0
Secondary outcome 2: Assessment of RSWT, HILT and combined therapy ofRSWT and HILT on activity on Laitinen questionnaire.
Timepoint [2] 416383 0
There are 3 timepoints for functional capabilities assessment. 1 - Prior to therapy, 2 - 1 day up to 7 days after therapy, 3- after 6 months after therapy. Additionally, pain intensity assessment will be done after each therapeutic session including RSWT (group 1 and 3)
Secondary outcome [3] 416384 0

Assessment of RSWT, HILT and combined therapy of RSWT and HILT on pain frequency on Laitinen questionnaire.
Timepoint [3] 416384 0
There are 3 timepoints for functional capabilities assessment. 1 - Prior to therapy, 2 - 1 day up to 7 days after therapy, 3- after 6 months after therapy. Additionally, pain intensity assessment will be done after each therapeutic session including RSWT (group 1 and 3)
Secondary outcome [4] 416385 0
Assessment of RSWT, HILT and combination therapy of ESWT and HILT for painkillers consumption based on the Laitinen questionnaire.
Assessment of pain frequency and frequency of taking painkillers on Laitinen questionnaire.
.
Timepoint [4] 416385 0
There are 3 timepoints for functional capabilities assessment. 1 - Prior to therapy, 2 - 1 day up to 7 days after therapy, 3- after 6 months after therapy. Additionally, pain intensity assessment will be done after each therapeutic session including RSWT (group 1 and 3)

Eligibility
Key inclusion criteria
1. Participants may be aged 18 years or older, yet younger than 90 years old.
2. Informed consent of the patient to participate in the study.
3. No contraindications to physiotherapy.
4. Diagnostic Image result (X-ray or ultrasound or MRI or CT) confirming the presence of enthesopathy in the plantar fascia.
5. Absence of any form of treatment for plantar fascia enthesopathy in the 6 months prior to enrollment in the study.
6. Feeling of pain associated with enthesopathy of the plantar fascia from 5 to 10 on the VAS scale (Visual Analogue Scale).
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age <18 years old
2. Lack of informed consent of the patient to participate in the study.
3. Contraindications to performing physical procedures (eg current or past cancer, pregnancy).
4. Patients with constant cardiac pacing or other implanted electronic implants.
5. The use of other forms of therapy or pharmacotherapy affecting the pain sensation and the state of enthesopathy in the area of the plantar fascia or injection of corticosteroids within 6 months before the examination.
6. Ongoing anticoagulant therapy.
7. Advanced deformities of lower limbs.
8. Lower limb asymmetry exceeding 2 cm.
9. The occurrence of autoimmune diseases.

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)
The experimental and placebo group allocations will be determined according to randomized codes.
Main coordinator who will allocate the participants to groups will have 70 opaque, sealed envelopes, each will be contained a piece of paper marked with number 1, 2 or 3. Envelopes will be placed in non-transparent box.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with sealed opaque envelope system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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
the sample size has been computed as follows. We assumed the effect size d=0.75,
a err prob = 0.05 and minimum power (1-ß err prob) = 0.85.
Computations made with the G*Power 3.0.10 software resulted in the minimum sample size for the treatment group equal to 35 and for the control group equal to 35.
statistical assumptions prepared based on the previous studies " Effectiveness of extra-corporeal shock wave therapy (ESWT) vs methylprednisolone injections in plantar fasciitis".J Clin Orthop Trauma. 2019;10(2):401-405.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/12/2022
Actual
Date of last participant enrolment
Anticipated
17/03/2023
Actual
Date of last data collection
Anticipated
16/06/2023
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 24666 0
Poland
State/province [1] 24666 0
warsaw

Funding & Sponsors
Funding source category [1] 311018 0
Self funded/Unfunded
Name [1] 311018 0
Country [1] 311018 0
Primary sponsor type
Individual
Name
Witold Rongies
Address
Rehabilitation Unit, Central Teaching Hospital, University Clinical Center, Medical University of Warsaw
1a Banacha, 02-097 Warsaw
Country
Poland
Secondary sponsor category [1] 312333 0
None
Name [1] 312333 0
Address [1] 312333 0
Country [1] 312333 0
Other collaborator category [1] 282213 0
Individual
Name [1] 282213 0
Dariusz Piszczyk
Address [1] 282213 0
Rehabilitation Unit, Doctoral School, Medical University of Warsaw
2c Ksiecia Trojdena, 02-109 Warsaw
Country [1] 282213 0
Poland
Other collaborator category [2] 282214 0
Individual
Name [2] 282214 0
Bartosz Slomka
Address [2] 282214 0
Rehabilitation Unit, Central Teaching Hospital, University Clinical Center, Medical University of Warsaw
1a Banacha, 02-097 Warsaw
Country [2] 282214 0
Poland
Other collaborator category [3] 282215 0
Individual
Name [3] 282215 0
Monika Lewandowska
Address [3] 282215 0
Rehabilitation Unit, Medical University of Warsaw
2c Ksiecia Trojdena, 02-109 Warsaw
Country [3] 282215 0
Poland
Other collaborator category [4] 282216 0
Individual
Name [4] 282216 0
Janusz Sierdzinski
Address [4] 282216 0
Department of Medical Information Technology and Telemedicine Medical University of Warsaw
Litewska 14/16 00-581 Warsaw
Country [4] 282216 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310565 0
Bioethics Committee of the Medical University of Warsaw
Ethics committee address [1] 310565 0
Zwirki i Wigury 61, 02-091 Warsaw, Poland
Ethics committee country [1] 310565 0
Poland
Date submitted for ethics approval [1] 310565 0
Approval date [1] 310565 0
14/03/2018
Ethics approval number [1] 310565 0
KB/30/2018

Summary
Brief summary
The aim of this study is to assess efficacy of three different therapeutic approaches with use of radial shockwave or high intensity laser in treatment of patients with plantar fasciitis. The main goal of the study is to determine whether therapies with HILT or RSWT combined with HILT are more effective in treatment of patients with plantar fasciitis than RSWT monotherapy. Treatment effectiveness will be rated basing on pain reduction and functional improvement noted on questionnaire prepared for physiotherapeutic examination. To assess pain reduction we will use VAS, NRS and Laitinen scale. Functional improvement in everyday situations will be assessed using a modified WOMAC questionnaire.Patients will be randomly assigned to one of three groups. First group will receive combined therapy of HILT and RSWT. Second group will receive HILT monotherapy and RSWT monotherapy will be applied in the third group.
The therapy will be carried out using BTL-5000 SWT Power + High Intensity Laser 12 device. Three applications of RSWT will be made in groups at the painful location with intervals of 5-7 days.
HILT will be applied for 6 consecutive working days.Each HILT application will be individually adapted to the size of the foot and will be performed using the labile method in the heel area. Before the therapy, during it and after therapy patient’s pain will be assessed using the VAS scale, Laitinen scale and functional fitness with use of WOMAC questionnaire. The patient's BMI will also be measured to assess correlation between pain relapses and BMI. Control visits will take place after the last therapeutic session and 6 months from the end of therapy, and they will consist of filling all study questionnaires to assess therapy effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118106 0
Prof Witold Rongies
Address 118106 0
Rehabilitation Unit, Central Teaching Hospital, University Clinical Center, Medical University of Warsaw
1a Banacha, 02-097 Warsaw
Country 118106 0
Poland
Phone 118106 0
+4822599 25 63
Fax 118106 0
Email 118106 0
rongies@interia.pl
Contact person for public queries
Name 118107 0
Mr Dariusz Piszczyk
Address 118107 0
Rehabilitation Unit, Doctoral School, Medical University of Warsaw
2c Ksiecia Trojdena, 02-109 Warsaw
Country 118107 0
Poland
Phone 118107 0
+4822599 25 63
Fax 118107 0
Email 118107 0
dariuszpiszczyk@gmail.com
Contact person for scientific queries
Name 118108 0
Mr Dariusz Piszczyk
Address 118108 0
Rehabilitation Unit, Doctoral School, Medical University of Warsaw
2c Ksiecia Trojdena, 02-109 Warsaw
Country 118108 0
Poland
Phone 118108 0
+4822599 25 63
Fax 118108 0
Email 118108 0
dariuszpiszczyk@gmail.com

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15434Ethical approval    383762-(Uploaded-26-05-2022-07-22-07)-Study-related document.pdf



Results publications and other study-related documents

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