Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001954213
Ethics application status
Approved
Date submitted
4/10/2018
Date registered
4/12/2018
Date last updated
22/10/2021
Date data sharing statement initially provided
4/12/2018
Date results information initially provided
22/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Extracorporeal Shock Wave Therapy on Plantar Fasciitis in Patients with Axial Spondyloarthropathies
Scientific title
The Effect of Extracorporeal Shock Wave Therapy on Plantar Fasciitis in Patients with Axial Spondyloarthropathies: a Double Blind Randomized Placebo-Controlled Study
Secondary ID [1] 295742 0
Nil known
Universal Trial Number (UTN)
U1111-1221-6666
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spondyloarthropathy
 309141 0
Plantar Fasciitis 309142 0
Condition category
Condition code
Physical Medicine / Rehabilitation 308025 308025 0 0
Other physical medicine / rehabilitation
Inflammatory and Immune System 308026 308026 0 0
Autoimmune diseases
Musculoskeletal 308027 308027 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Extracorporeal shock wave therapy (ESWT) is a new technology using a ballistic source to generate pressure waves. The shock waves can be radial or focused. Radial ESWT (rESWT) is a low to medium energy shock wave with a low penetration power compared with focus ESWT. ESWT has commonly been used for the treatment of plantar fasciitis. This study is planned as double-blind, randomized sham-controlled trial. Participants are randomly allocated to three groups: the 500 pulses ESWT group, the 1000 pulses ESWT group and the sham group. Radial ESWT will be applied in this study. ESWT groups will receive radial ESWT one session per week for three weeks. Each session will last for 2-5 minutes. 500 pulses are applied to plantar fascia of the affected side with a frequency of 10 Hertz (Hz) and pressure of 1,8 Bar for the 500 pulses ESWT group. 1000 pulses are applied to plantar fascia of the affected side with a frequency of 10 Hertz (Hz) and pressure of 1,8 Bar for the 1000 pulses ESWT group.The sham group will recieve sham ESWT one session per week for three weeks. For sham group, we will record the sound of ESWT therapy session. The recorded sound will be turned on but the ESWT probe will be off. The patient will be in the prone position during this treatment. For this reason, the patient can not see the ESWT screen. The people receiving the therapy and the people assessing the outcomes are blinded. Intelect RPW Shockwave by Chattanooga Corporation will be used in this study. Radial ESWT will be applied to all participants by the same physiotherapist at least 10 years of experience in Department of Phsical Medicine and Rehabilitation of Ibni Sina Hospital.
Intervention code [1] 312070 0
Treatment: Devices
Intervention code [2] 312071 0
Rehabilitation
Comparator / control treatment
Placebo-controlled: Sham ESWT
Sham ESWT group will recieve ESWT one session per week for three weeks. We will record the sound of ESWT therapy session. For sham group, the recorded sound will be turned on but the ESWT probe will be off.
Control group
Placebo

Outcomes
Primary outcome [1] 307097 0
Visual Analog Scale: Change in heel pain of affected side assessed using Visual Analog Scale (0-10)
Timepoint [1] 307097 0
Heel pain-will be assessed by Visual Analog Scale At baseline, immediately after the last ESWT session, 4 weeks after the last ESWT session, 8 weeks after the last ESWT session,
Secondary outcome [1] 350677 0
Foot Function Index: Foot function would be assessed by Foot Function Index.
Timepoint [1] 350677 0
At baseline, immediately after the last ESWT session, 4 weeks after the last ESWT session, 8 weeks after the last ESWT session.
Secondary outcome [2] 350678 0
Pressure Pain Treshold measurement assessed using Pressure Algometer
Timepoint [2] 350678 0
At baseline, immediately after the last ESWT session, 4 weeks after the last ESWT session, 8 weeks after the last ESWT session,
Secondary outcome [3] 350679 0
Thickness in plantar fascia assessed using Ultrasonography
Timepoint [3] 350679 0
At baseline, immediately after the last ESWT session, 4 weeks after the last ESWT session, 8 weeks after the last ESWT session,
Secondary outcome [4] 350680 0
Homogeneity in plantar fascia assessed using Ultrasonography
Timepoint [4] 350680 0
At baseline, immediately after the last ESWT session, 4 weeks after the last ESWT session, 8 weeks after the last ESWT session,
Secondary outcome [5] 350681 0
Presence of synovitis in plantar fascia assessed using Ultrasonography
Timepoint [5] 350681 0
At baseline, immediately after the last ESWT session, 4 weeks after the last ESWT session, 8 weeks after the last ESWT session,
Secondary outcome [6] 350682 0
Effusion around the plantar fascia assessed using Ultrasonography
Timepoint [6] 350682 0
At baseline, immediately after the last ESWT session, 4 weeks after the last ESWT session, 8 weeks after the last ESWT session,

Eligibility
Key inclusion criteria
Axial Spondyloarthropathy
Between 18 and 65 years of age
Heel pain lasting at least 3 months
Pain intensity is equal or more than 5 points out of 10 according to Visual Analog Scale
At least two different conservative treatment failures
Patients who have admitted not to take non-steroidal anti inflammatory drug if not using before
Patients who have admitted not to switch to another non-steroidal anti inflammatory drug if using
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient with malignancy
Patient with bleeding diathesis
Patient with active synovitis in plantar fascia
Patient with cognitive impairment, limitation of cooperation
Pregnancy
Patients with severe osteoporosis
Patients with cardiac pacemaker
Patients with peripheral vascular disease
Patients with calcaneal fracture

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)
A sealed opaque envelope method will be used to ensure privacy
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised into two groups. For this purpose Randomisation Allocation Software program will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mean, standard deviation, median, min-max and percentile values will be calculated for the socio-demographic and clinical features, primary and secondary outcome measures by descriptive statistics. The one way Anova test will be used to evaluate differences within groups for parametric measures. The Mann Whitney U test will be used to evaluate differences between groups for non parametric measures. The relationship between clinical results and the ultrasonography will be evaluated by Spearman’s test. P value of less than 0.05 was considered as statistically significant. When the power analysis was made by taken Visual Analog Scale as primary outcome variable of the study, Power of the study was calculated to 80% with 10 patients in each group using effect size of 1,00. A total of at least 30 patients are planned to be included in the study

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/12/2018
Actual
15/12/2018
Date of last participant enrolment
Anticipated
16/03/2020
Actual
12/07/2021
Date of last data collection
Anticipated
29/05/2020
Actual
20/09/2021
Sample size
Target
30
Accrual to date
Final
22
Recruitment outside Australia
Country [1] 20777 0
Turkey
State/province [1] 20777 0
Ankara

Funding & Sponsors
Funding source category [1] 300333 0
Other Collaborative groups
Name [1] 300333 0
Turkish League Against Rheumatism
Country [1] 300333 0
Turkey
Primary sponsor type
Other Collaborative groups
Name
Turkish League Against Rheumatism
Address
Yasam Caddesi No: 13/A Neorama Plaza Kat:6 Daire:26 Sögütözü/ANKARA
Country
Turkey
Secondary sponsor category [1] 299770 0
None
Name [1] 299770 0
Address [1] 299770 0
Country [1] 299770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301145 0
Ankara University Faculty of Medicine Ethics Committee
Ethics committee address [1] 301145 0
Ankara University Faculty of Medicine Ethics Committee
SIHHIYE/ANKARA
Ethics committee country [1] 301145 0
Turkey
Date submitted for ethics approval [1] 301145 0
21/05/2018
Approval date [1] 301145 0
28/05/2018
Ethics approval number [1] 301145 0
09-610-18

Summary
Brief summary
Plantar fasciitis is inflammation of plantar fascia. It arises from degeneration, chronic inflammation, microtrauma and axial spondyloarthropathy. Treatment of plantar fasciitis contains conservative methods like rest, body weight control, stretching exercise, non-steroidal anti-inflammatory drugs and arch supports. ESWT has commonly been used for the treatment of plantar fasciitis. The shock waves can be radial or focused.
Plantar fasciitis is commonly seen in axial spondyloarthropathy patients. Degenerative and inflammatory pathways play a role together in development of plantar fasciitis in axial spondyloarthropathy patients. Within the available literature there are no study that investigated the effect of ESWT on plantar fasciitis in axial spondyloarthropathy patients. The aim of this study was to evaluate the effectiveness of rESWT in plantar fasciitis in axial spondyloarthropathy patients and to reveal the relationship of this effect with the sonographic features of plantar fascia. This study is planned as double-blind, randomized placebo-controlled trial. Participants are randomly allocated to two groups: the ESWT group and the sham group. Radial ESWT will be applied in this study. This study is planned as double-blind, randomized sham-controlled trial. Participants are randomly allocated to two groups: the ESWT group and the sham group. ESWT group will receive radial ESWT one session per week for three weeks. Each session will last for 2-5 minutes. The ESWT group, 500 pulses are applied to plantar fascia of the affected side with a frequency of 10 Hertz (Hz) and pressure of 1,8 Bar. The sham group will recieve sham ESWT one session per week for three weeks. For sham group, we will record the sound of ESWT therapy session. The recorded sound will be turned on but the ESWT probe will be off. The patient will be in the prone position during this treatment. For this reason, the patient can not see the ESWT screen. Each session will last for 2-5 minutes. The people receiving the therapy and the people assessing the outcomes are blinded . Both group will recieve ESWT one session per week for three weeks. Each session will last for 2-5 minutes. The primary outcome measure of this study is change in heel pain of affected side assessed using Visual Analog Scale. The secondary outcome measure is sonographic features of plantar fascia. The primary endpoint of this study is to determine a decrease in pain score at least 2 point according to Visual Analog Scale.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86002 0
Prof Sehim KUTLAY
Address 86002 0
Ankara University Faculty of Medicine
Department of PMR Ibni Sina Hospital
Sihhiye 06100
Ankara
Country 86002 0
Turkey
Phone 86002 0
+903125082940
Fax 86002 0
+903125083935
Email 86002 0
[email protected]
Contact person for public queries
Name 86003 0
Prof Sehim KUTLAY
Address 86003 0
Ankara University Faculty of Medicine
Department of PMR Ibni Sina Hospital
Sihhiye 06100
Ankara
Country 86003 0
Turkey
Phone 86003 0
+903125082940
Fax 86003 0
+903125083935
Email 86003 0
[email protected]
Contact person for scientific queries
Name 86004 0
Prof Sehim KUTLAY
Address 86004 0
Ankara University Faculty of Medicine
Department of PMR Ibni Sina Hospital
Sihhiye 06100
Ankara
Country 86004 0
Turkey
Phone 86004 0
+903125082940
Fax 86004 0
+903125083935
Email 86004 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient follow-up reports
When will data be available (start and end dates)?
30/12/2021-30/12/2022
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Available to achieve the aims in the approved proposal
How or where can data be obtained?
IPD will be shared by e-mail.


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
SourceTitleYear of PublicationDOI
EmbaseThe efficacy and safety of extracorporeal shock wave therapy on plantar fasciitis in patients with axial spondyloarthritis: a double-blind, randomized controlled trial.2022https://dx.doi.org/10.1007/s00296-022-05098-0
N.B. These documents automatically identified may not have been verified by the study sponsor.