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The Effect of Extracorporeal Shock Wave Therapy on Plantar Fasciitis in Patients with Axial Spondyloarthropathies

The Effect of Extracorporeal Shock Wave Therapy on Plantar Fasciitis in Patients with Axial Spondyloarthropathies: a Double Blind Randomized Placebo-Controlled Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001954213
Enrollment
22
Registered
2018-12-04
Start date
2018-12-15
Completion date
2021-07-12
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 pu

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.

Sponsors

Turkish League Against Rheumatism
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026