Clinical trial NCT06697860: Effect of Radial Shockwave Therapy and Graston Instrument Assisted Soft Tissue Mobilization on Plantar Fasciitis
Official title: Comparative Effect of Radial Shockwave Therapy and Graston Instrument Assisted Soft Tissue Mobilization on Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plantar Fascia
Keywords: Radial Shockwave Therapy
Graston Instruments
Softtissue Mobilization
Plantar fascia
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Plantar fasciitis is a common musculoskeletal disorder characterized by inflammation of the plantar fascia, causing heel pain and discomfort. Various treatment modalities have been explored to alleviate symptoms, with Radial Shockwave Therapy (RST) and Graston Instrument-Assisted Soft Tissue Mobilization (IASTM) emerging as promising interventions.This study aims to compare the effectiveness of these two treatments in managing plantar fasciitis. RST offers a non-invasive alternative for individuals suffering from plantar fasciitis particularly crucial for patients who prefer conservative treatments or want to explore less invasive options before considering surgery also stimulate the body's natural healing processes by promoting blood flow and tissue regeneration.

Detailed description: Study Design will be randomized clinical trial. Study setting will be Sehat medical complex Lahore. Study Duration will be 4 months after synopsis approval Sample size will be 40 calculated by Epitool ,intervention group will be Group A: Radial Shock Therapy(RST) , Group B: Graston Instrument Assisted Soft Tissue Mobilization (GIASTM). Purposive sampling technique will be implanted. Both genders (male/female).Age 20 to 45 years, Pre-diagnosed with chronic plantar fasciitis, Heel pain will be included. Patients with rheumatoid arthritis, osteoporosis and ankle and foot bursitis were excluded. VAS scale (visual analogue scale), Foot function index (FFI), 12-Item Short-Form Health Survey and goniometer will be data collection tools. SPSS version 25 will be used for statistical analysis. Shapiro-wilks test for normality will be used to assess the normality of the data after which it will be decided either parametric or non-parametric test will be used within and across the group.

Eligibility criteria: Inclusion Criteria:

* Both genders (male/female) Age 20 to 45 (25) unilateral chronic plantar fasciitis of more than 3 months Pre diagnosed with chronic plantar fasciitis soreness and local tenderness bottom of the heel. Searing or piercing type pain (26) Pain greater than four on the visual analogue scale (VAS) during the first steps in the morning(10) gradual development of pain with no trauma(27) pain generated by local pressure(26) Increase in pain in the morning upon taking a few steps or after prolonged non-weight bearing(28) symptoms decreasing with slight levels of activity, such as walking(11) No previous history of radial shockwave therapy or Graston technique for plantar fasciitis

Exclusion Criteria:

- Having lower limb pathology (24) Tarsal tunnel syndrome (TTS) Fat-pad syndrome(11) Have heel spurs(26) Bilateral PF Previous ankle or foot surgery History of topical corticosteroid injections to the ankle or foot Neuropathic or radicular pain in the lower limbs Participants with systemic diseases that cause foot discomfort, such as ankylosing spondylitis, osteoporosis psoriatic arthritis, rheumatoid arthritis, and gout, foot bursitis, as well as those with type I or type II diabetes and pregnancy, were also excluded from the study.(25)

Primary outcomes:
measure: Foot function Index
timeFrame: 8 weeks
measure: -Item Short-Form Health Survey
timeFrame: 8 weeks
measure: VAS (Visual analogue scale)
timeFrame: 8 weeks
measure: Goniometer
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sehat Medical Complex
state: Punjab
Study officials:
affiliation: Riphah International University
name: SABA RAFIQUE, MsPT(OMPT)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tu P. Heel Pain: Diagnosis and Management. Am Fam Physician. 2018 Jan 15;97(2):86-93.
citation: Sichting F, Holowka NB, Ebrecht F, Lieberman DE. Evolutionary anatomy of the plantar aponeurosis in primates, including humans. J Anat. 2020 Jul;237(1):85-104. doi: 10.1111/joa.13173. Epub 2020 Feb 26.
citation: Carek PJ, Edenfield KM, Michaudet C, Nicolette GW. Foot and Ankle Conditions: Plantar Fasciitis. FP Essent. 2018 Feb;465:11-17.
citation: Yelverton C, Rama S, Zipfel B. Manual therapy interventions in the treatment of plantar fasciitis: A comparison of three approaches. Health SA. 2019 Sep 25;24:1244. doi: 10.4102/hsag.v24i0.1244. eCollection 2019.