Plantar FasciaNCT06697860
Effect of Radial Shockwave Therapy and Graston Instrument Assisted Soft Tissue Mobilization on Plantar Fasciitis
A study testing Radial Shockwave Therapy and Graston Instrument in people with Plantar Fascia, run by Riphah International University at 1 site in Pakistan.
Trial 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)… Read more about this study
- Who is it for?
- Ages 20 to 45 weeks
- Conditions the study is for
- Plantar Fascia
- What is being tested?
- Radial Shockwave Therapy and Graston Instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Jan 2024to 7 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Sehat Medical Complex
Lahore, Punjab Province, 54790
Hassan Javed, M.Phill, 03446673667, drhassanjaved.psrd@gmail.com
MAIRA SARFARAZ, MsPT(OMPT)
About this study
Official title: Comparative Effect of Radial Shockwave Therapy and Graston Instrument Assisted Soft Tissue Mobilization on Plantar Fasciitis
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.
Read the 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.
- Conditions
- Plantar Fascia
- Being tested
- Radial Shockwave Therapy, Graston Instrument
- Keywords
- Radial Shockwave Therapy, Graston Instruments, Softtissue Mobilization, Plantar fascia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Shockwave TherapyDevice
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 InstrumentDevice
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..
| Study group | Role | What they receive |
|---|---|---|
| Radial Shockwave Therapy | Experimental | Radial Shockwave therapy in Plantar Fasciitis. Receives: Device: Radial Shockwave Therapy |
| Graston instrument | Experimental | Graston Instrument assisted soft tissue mobilization on Plantar Fasciitis. Receives: Device: Graston Instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot function Index
A Foot Function Index (FFI) was developed to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced. The FFI was examined for test-retest reliability, internal consistency, and construct and criterion validity. A total of 87 patients with rheumatoid arthritis were used in the study. Test-retest reliability of the FFI total and sub-scale scores ranged from 0.87 to 0.69. Internal consistency ranged from 0.96 to 0.73. With the exception of two items, factor analysis supported the construct validity of the total index and the sub-scales. Strong correlation between the FFI total and sub-scale scores and clinical measures of foot pathology supported the criterion validity of the index. The FFI should prove useful for both clinical and research purposes (29).
Measured: 8 weeks
-Item Short-Form Health Survey
The 12-Item Short Form Health Survey (SF-12) was developed for the Medical Outcomes Study (MOS), a multi-year study of patients with chronic conditions. The resulting short-form survey instrument provides a solution to the problem faced by many investigators who must restrict survey length. The instrument was designed to reduce respondent burden while achieving minimum standards of precision for purposes of group comparisons involving multiple health dimensions. The instrument has been validated across a number of chronic diseases and conditions (22, 31-34) the test-retest reliability was found to be an ICC of 0.61 for PCS and 0.57 for MCS, adjusting for age, sex, race/ethnicity, and CRG.(31)
Measured: 8 weeks
VAS (Visual analogue scale)
A Visual Analogue Scale (VAS) is one of the pain rating scale will be used for measuring the pain intensity with the categorization of none, mild, moderate and severe would suggest. It was to capture this idea of an underlying continuum that the VAS was devised (29) Reliability of VAS is high, ICC = 0.99 [95%CI 0.989 to 0.992] for 0 and 1 minute VAS scores. (30)
Measured: 8 weeks
Goniometer
Goniometer: for measuring the ankle range of motion, goniometer will be used. Reliability of the goniometer was found for all measurements ranging from, Intra-class Correlation Coefficients for goniometry > 0.94. The concurrent validity of goniometer was good with ICC values of >0.85. The goniometer will be used to measure plantar flexion, dorsiflexion, inversion and eversion of the ankle joint.(35)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start4 Jan 2024
- Primary completion7 Jan 2025 (estimated)
- Study completion7 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SABA RAFIQUE, MsPT(OMPT), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697860
- Sponsor's protocol ID
- REC/RCR & AHS/24/0112
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tu P. Heel Pain: Diagnosis and Management. Am Fam Physician. 2018 Jan 15;97(2):86-93.
PubMed 29365222Sichting 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.
PubMed 32103502Carek PJ, Edenfield KM, Michaudet C, Nicolette GW. Foot and Ankle Conditions: Plantar Fasciitis. FP Essent. 2018 Feb;465:11-17.
PubMed 29381040Yelverton 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.
PubMed 31934436
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Radial Shockwave Therapy and Graston Instrument Assisted Soft Tissue Mobilization on Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT06697860
- Acronym / sponsor ID
- REC/RCR & AHS/24/0112
- Conditions
- Plantar Fascia
- Keywords
- Radial Shockwave Therapy, Graston Instruments, Softtissue Mobilization, Plantar fascia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 7 Jan 2025 (estimated)
- Study completion
- 7 Jan 2025 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial Shockwave Therapy | Experimental | Device: Radial Shockwave TherapyRadial Shockwave therapy in Plantar Fasciitis. |
| Graston instrument | Experimental | Device: Graston InstrumentGraston Instrument assisted soft tissue mobilization on Plantar Fasciitis. |
Who may qualify
- Ages
- 20 to 45 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial Shockwave TherapyIn 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. | Device | Radial Shockwave Therapy |
| Graston InstrumentGroup 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.. | Device | Graston instrument |
Primary outcome
Foot function Index
Time frame: 8 weeks
A Foot Function Index (FFI) was developed to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced. The FFI was examined for test-retest reliability, internal consistency, and construct and criterion validity. A total of 87 patients with rheumatoid arthritis were used in the study. Test-retest reliability of the FFI total and sub-scale scores ranged from 0.87 to 0.69. Internal consistency ranged from 0.96 to 0.73. With the exception of two items, factor analysis supported the construct validity of the total index and the sub-scales. Strong correlation between the FFI total and sub-scale scores and clinical measures of foot pathology supported the criterion validity of the index. The FFI should prove useful for both clinical and research purposes (29).
-Item Short-Form Health Survey
Time frame: 8 weeks
The 12-Item Short Form Health Survey (SF-12) was developed for the Medical Outcomes Study (MOS), a multi-year study of patients with chronic conditions. The resulting short-form survey instrument provides a solution to the problem faced by many investigators who must restrict survey length. The instrument was designed to reduce respondent burden while achieving minimum standards of precision for purposes of group comparisons involving multiple health dimensions. The instrument has been validated across a number of chronic diseases and conditions (22, 31-34) the test-retest reliability was found to be an ICC of 0.61 for PCS and 0.57 for MCS, adjusting for age, sex, race/ethnicity, and CRG.(31)
VAS (Visual analogue scale)
Time frame: 8 weeks
A Visual Analogue Scale (VAS) is one of the pain rating scale will be used for measuring the pain intensity with the categorization of none, mild, moderate and severe would suggest. It was to capture this idea of an underlying continuum that the VAS was devised (29) Reliability of VAS is high, ICC = 0.99 [95%CI 0.989 to 0.992] for 0 and 1 minute VAS scores. (30)
Goniometer
Time frame: 8 weeks
Goniometer: for measuring the ankle range of motion, goniometer will be used. Reliability of the goniometer was found for all measurements ranging from, Intra-class Correlation Coefficients for goniometry > 0.94. The concurrent validity of goniometer was good with ICC values of >0.85. The goniometer will be used to measure plantar flexion, dorsiflexion, inversion and eversion of the ankle joint.(35)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Background: PubMed 29365222Tu P. Heel Pain: Diagnosis and Management. Am Fam Physician. 2018 Jan 15;97(2):86-93.
- Background: PubMed 32103502Sichting 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.
- Background: PubMed 29381040Carek PJ, Edenfield KM, Michaudet C, Nicolette GW. Foot and Ankle Conditions: Plantar Fasciitis. FP Essent. 2018 Feb;465:11-17.
- Background: PubMed 31934436Yelverton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SABA RAFIQUE, MsPT(OMPT) principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Shockwave Therapy and Graston Instrument in people with Plantar Fascia, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Imran Amjad, Phd (imranamjad@ripha.edu.pk ext. 03324390125, imranamjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot function Index (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06697860, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.