Effect of Radial Shockwave Therapy and Graston Instrument Assisted Soft Tissue Mobilization on Plantar Fasciitis

NCT ID: NCT06697860

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-04

Study Completion Date

2025-01-07

Brief Summary

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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

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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.

Conditions

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Plantar Fascia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Radial Shockwave Therapy

Radial Shockwave therapy in Plantar Fasciitis.

Group Type EXPERIMENTAL

Radial Shockwave Therapy

Intervention Type DEVICE

In Group A, Radial Shockwave Therapy (RST) was given to the plantar fascia for 5 minutes, with each session consisting of 5-10 shock wave pulses of varied intensity. Following that, stretching exercises for the plantar fascia and calf muscles were done for 30 minutes, with three sets of 30-second holds for each stretch. This therapy procedure was followed out in weekly sessions for 8 weeks, each lasting 40 minutes in total.

Graston instrument

Graston Instrument assisted soft tissue mobilization on Plantar Fasciitis.

Group Type EXPERIMENTAL

Graston Instrument

Intervention Type DEVICE

Group B employed Graston Instrument-Assisted Soft Tissue Mobilization (IASTM) for 5-10 minutes to target and break down plantar fascia adhesions. The therapist used a specialized device to apply controlled, precise pressure to the fascia. Following that, stretching exercises for the plantar fascia and calf muscles were done for 30 minutes, with three sets of 30-second holds for each. The entire therapy procedure was carried out in weekly sessions for 8 weeks, each lasting 40 minutes in total..

Interventions

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Radial Shockwave Therapy

In Group A, Radial Shockwave Therapy (RST) was given to the plantar fascia for 5 minutes, with each session consisting of 5-10 shock wave pulses of varied intensity. Following that, stretching exercises for the plantar fascia and calf muscles were done for 30 minutes, with three sets of 30-second holds for each stretch. This therapy procedure was followed out in weekly sessions for 8 weeks, each lasting 40 minutes in total.

Intervention Type DEVICE

Graston Instrument

Group B employed Graston Instrument-Assisted Soft Tissue Mobilization (IASTM) for 5-10 minutes to target and break down plantar fascia adhesions. The therapist used a specialized device to apply controlled, precise pressure to the fascia. Following that, stretching exercises for the plantar fascia and calf muscles were done for 30 minutes, with three sets of 30-second holds for each. The entire therapy procedure was carried out in weekly sessions for 8 weeks, each lasting 40 minutes in total..

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

20 Weeks

Maximum Eligible Age

45 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SABA RAFIQUE, MsPT(OMPT)

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Sehat Medical Complex

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Imran Imran Amjad, Phd

Role: CONTACT

Imran Imran Amjad, PhD

Role: CONTACT

051 5481826

Facility Contacts

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Hassan Javed, M.Phill

Role: primary

03446673667

References

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Tu P. Heel Pain: Diagnosis and Management. Am Fam Physician. 2018 Jan 15;97(2):86-93.

Reference Type BACKGROUND
PMID: 29365222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32103502 (View on PubMed)

Carek PJ, Edenfield KM, Michaudet C, Nicolette GW. Foot and Ankle Conditions: Plantar Fasciitis. FP Essent. 2018 Feb;465:11-17.

Reference Type BACKGROUND
PMID: 29381040 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31934436 (View on PubMed)

Other Identifiers

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REC/RCR & AHS/24/0112

Identifier Type: -

Identifier Source: org_study_id

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