Plantar FascitisNCT06686706
Effects of IASTM and Kinesiotaping in Plantar Fascitis
A study testing IASTM and KT group in people with Plantar Fascitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The Objective of the study is to compare the effectiveness of Instrumental Assisted Soft Tissue Mobilization (IASTM) and Kinesio taping for improving foot functional status and Quality of Life (QOL) in patients with Plantar Fasciitis. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- IASTM and KT group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to 13 Dec 2024
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders
- Age Range of 20-40 years
- Standing > 8 hours a day
- Positive Windlass test
- Patients who experience pain on medial tuberosity of the calcaneus on palpation.
- Pain during the initial steps that lessened after a few steps but aggravated by increased activity
Who cannot join
- History of ankle or foot surgery
- Patients with inflammatory conditions like cancer, rheumatoid arthritis, ankle and foot bursitis.
- Foot related complications after fracture
- Patients receiving corticosteroid injections
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
Bahria Active
Rawalpindi, Punjab Province, 46300
Dr. Amman Ullah Nazir, PhD*, 0333 5330065, aman.nazir@riphah.edu.pk
Shumaila Parveen, MS-OMPT
About this study
Official title: Comparing the Effectiveness of Instrumental Assisted Soft Tissue Mobilization (IASTM) and Kinesio Taping on Foot Functional Status and Quality of Life (QOL) in Plantar Fasciitis
The Objective of the study is to compare the effectiveness of Instrumental Assisted Soft Tissue Mobilization (IASTM) and Kinesio taping for improving foot functional status and Quality of Life (QOL) in patients with Plantar Fasciitis. The study will be randomized controlled Trial including 2 experimental groups and 19 participants in each group
Read the detailed description
Plantar fasciitis is one of the most frequent foot problems that affects 11 to 15% of people with foot problems between the ages of 25 and 65 years old who walk and stand for a long time at the workplace. It is a chronic inflammatory disorder that occurs at the medial calcaneal tuberosity as a reaction to repeated injury or exposure to tremendous pressures at the calcaneus insertion, causing inflammation and plantar fascia tears. It is one of the most common causes of heel pain that affects more than 3 million people in the United States alone every year. It is thought to affect 4-10% of the general population.
The thick band of connective tissue that runs the length of the foot and supports the arch is called the plantar fascia. It plays a vital role in maintaining arch of foot and absorbing shock while weight bearing activities. It has three components: a thinner medial and lateral component, and a thicker central component. The plantar fascia forms the longitudinal arch of the foot by inserting into each metatarsal head after emerging from the posteromedial calcaneal tuberosity. Some reported cases of plantar fasciitis are the result of biomechanical failure that provides tension along the plantar fascia.
Risk factors that cause damage to the plantar fascia include excessive foot pronation, jogging, obesity, prolonged standing, and inadequate ankle dorsiflexion. Limited ankle dorsiflexion, a body mass index higher than 27 kg per m2 and spending the most of the workday on one's feet are risk factors for developing plantar fasciitis in non-athletes. The most common symptom is painful medial plantar heel pain in the first few steps after sitting or sleeping. The pain usually goes away after further ambulation, but it can return with continued weightbearing.
Traditionally, it was believed that plantar fasciitis is induced by mechanical damage in which the plantar fascia was subjected to excessive tensile strain, which caused tiny tears and persistent inflammation. According to current theories, plantar fasciitis develops through a deterioration of fascia, which is why it is sometimes referred to as Fasciosis rather than Fasciitis, where maximum stress is the main factor in the etiology. Gap junctions between fibrocytes specifically perceive the increased fascial stress, which subsequently mediates alterations in the extracellular matrix, leading to myxoid deterioration and breakage of the plantar fascia.
Among the conservative therapy approaches for Plantar Fasciitis (PF) include activity modification, ice massage, stretching exercises, orthotics, oral analgesics, and corticosteroid injections. Low-level laser therapy, ultrasound therapy, and extracorporeal shockwave therapy (ESWT) are further treatment options for chronic plantar fasciitis (LLLT). Clinicians commonly employ a form of manual treatment called soft tissue mobilization/manipulation (STM) to lessen the pain and dysfunction brought on by musculoskeletal disorders. 87% of doctors use manual therapy on a daily basis. Instrumental Assisted Soft Tissue Mobilization (IASTM's) myofascial restriction, which is based on James Cyriax's soft tissue mobilization, gained increased attention recently. It has been proposed that IASTM acts as a neuromodulatory factor in pain regulation by activating mechanosensitive neurons found in the soft tissues that have been treated. The deformation of the skin may result in a reduction in the activity of fiber neurons, potentially producing an analgesic effect.
KT is an elastic therapeutic taping tool consisting of mainly of cotton, introduced by Dr. Kenso Kase in 1970s. It is lightweight, waterproof, breathable, and available in wide range of colors, types, lengths, textures. These features allow for multiple day wear and a constant pulling force on the skin. This pulling force to the skin on which kinesiotape is applied is thought to improve blood and lymphatic circulation, resulting in pain and edema relief. Following assessments and instructions from healthcare professionals, KT can be directly fixed to target tissue with combination of cuts (e.g. Y, I, X tape), tensions (% of stretch) and directions (e.g. muscle insertion to origin). Wearing KT maintain effect for 3-5 days, ideally following the 24 hours application rule based on skin condition. KT's therapeutic effects include increasing subcutaneous space, stimulating skin sensory receptors, supporting mechanical behavior, promoting micro circulation, and relieving pain in musculoskeletal disorders, improving proprioception stability, range of motion, and quality of life.
Previous studies have primarily focused on the effectiveness of Kinesio tapping solely on pain, function and quality of life in plantar fasciitis. In the past study, it was suggested to use conventional therapy along with Kinesio tape. Conventional therapies aim to alleviate pain, reduce inflammation and restore normal function. Thus, investigating the effectiveness of combining conventional therapy with Kinesio tapping in improving foot function and QOL in patients with plantar fasciitis. This research aims to fill the existing gap in literature by providing evidence-based guidance on optimal management approach for plantar fasciitis.This study will contribute in describing that which technique is best in management of plantar fasciitis and define the effects of both techniques on improving functional status and QOL.
- Conditions
- Plantar Fascitis
- Being tested
- IASTM, KT group
- Keywords
- Plantar Fascitis, IASTM, Graston technique, Kinesio Taping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASTMOther
Graston therapy-8 min per session
Procedure:
The patient will be lying down with their knee bent 30 degrees. After a 5-minute ultrasound treatment and static stretching exercises.Treatment will be administered using the Graston tool (using the sweep approach). Applying a moderate amount of effort from the medial side of the heel to the metatarsals and from the metatarsals to the medial side of the heel, to-and-fro stroking at a 60° angle will be done on the sole of the foot for approximately eight minutes (60-70 strokes per minute with a 5- to 10-second rest interval. A cold pack will be used for five minutes after therapy. The GT session will last approximately 30 minutes.
Conventional Therapy:
Therapeutic ultrasound for 5 min Stretching of plantar fascia 5 reps with 10 sec hold) Cold therapy for 5 min Functional status and Quality of Life (QOL) will be assessed before and after treatment of 4 weeks using using tools.
Intervention will be conducted once a week for 4 weeks.
KT groupOther
Kinesio tapping (left there for 3 days)
Procedure:
We will use a standard 2" (5 cm) kinesiology tape. Fascia tape will be applied to the plantar fascia, and it will be left there for three days. For four weeks, it will be applied once a week. The patient will be in a prone position, lying with the ankle joints in a neutral position while applying tape. With the toes extended against the bed or ground. The tape will be marked on the Achilles tendon. It will be cut longitudinally into five slices of equal width. It will be applied to the forefoot by stretching it by 25%. The last strap will be applied with gentle compression across the bases of the five slices beneath the foot and wrapped around the rear foot.(5) Conventional Therapy Therapeutic ultrasound for 5 min Stretching of plantar fascia 5 reps with 10 sec hold) Cold therapy for 5 min
| Study group | Role | What they receive |
|---|---|---|
| IASTM Group | Experimental | Instrumental Assisted Soft Tissue Mobilization Receives: Other: IASTM |
| KT Group | Experimental | Kinesiotaping Receives: Other: KT group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot and Ankle Outcome Score (FAOS):
FAOS is a 42-item questionnaire divided into 5 subscales pain (9 items), other symptoms (7 items), ADL (17 items), sport/recreation (5 items) and quality of life (4 items). A five-point Likert scale, with 0 denoting no problem, 1 mild, 2 moderate, 3 severe, and 4 extreme problems, is used to grade each item. Each subscale's total score is summed together and divided by the subscale's maximum score, to determine the score for each subscale. A scale of 0 to 100 is created from the normalized score, where 100 represents no problems and 0 represents severe problems.
Measured: 4 weeks
SF-12
A short health survey-12 version 2 is used to measure quality of life (SF-12 V.2). The patients' overall health and quality of life will be assessed using this questionnaire. There are twelve questions on the assessment form, and the answers can be used to score eight different areas of health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less on the PCS-12 has been recommended as a cut-off to determine a physical condition; while a score of 42 or less on the MCS-12 may be indicative of 'clinical depression'. There are two categories on the SF-12 V.2 surveys: Mental and Physical health. Cronbach's alpha values, which ranged from 0.60 to 0.87, supported the dependability and internal consistency.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 May 2024
- Primary completion13 Dec 2024 (estimated)
- Study completion13 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shumaila Parveen, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686706
- Sponsor's protocol ID
- Riphah/RCRAHS/REC/MS-PT/01943
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang J, Nie D, Rocha JL, Hogan MV, Wang JH. Characterization of the structure, cells, and cellular mechanobiological response of human plantar fascia. J Tissue Eng. 2018 Oct 3;9:2041731418801103. doi: 10.1177/2041731418801103. eCollection 2018 Jan-Dec.
PubMed 30302189
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Instrumental Assisted Soft Tissue Mobilization (IASTM) and Kinesio Taping on Foot Functional Status and Quality of Life (QOL) in Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT06686706
- Acronym / sponsor ID
- Riphah/RCRAHS/REC/MS-PT/01943
- Conditions
- Plantar Fascitis
- Keywords
- Plantar Fascitis, IASTM, Graston technique, Kinesio Taping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 13 Dec 2024 (estimated)
- Study completion
- 13 Dec 2024 (estimated)
- First posted
- 13 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.
The Objective of the study is to compare the effectiveness of Instrumental Assisted Soft Tissue Mobilization (IASTM) and Kinesio taping for improving foot functional status and Quality of Life (QOL) in patients with Plantar Fasciitis. The study will be randomized controlled Trial including 2 experimental groups and 19 participants in each group
Detailed description
Plantar fasciitis is one of the most frequent foot problems that affects 11 to 15% of people with foot problems between the ages of 25 and 65 years old who walk and stand for a long time at the workplace. It is a chronic inflammatory disorder that occurs at the medial calcaneal tuberosity as a reaction to repeated injury or exposure to tremendous pressures at the calcaneus insertion, causing inflammation and plantar fascia tears. It is one of the most common causes of heel pain that affects more than 3 million people in the United States alone every year. It is thought to affect 4-10% of the general population.
The thick band of connective tissue that runs the length of the foot and supports the arch is called the plantar fascia. It plays a vital role in maintaining arch of foot and absorbing shock while weight bearing activities. It has three components: a thinner medial and lateral component, and a thicker central component. The plantar fascia forms the longitudinal arch of the foot by inserting into each metatarsal head after emerging from the posteromedial calcaneal tuberosity. Some reported cases of plantar fasciitis are the result of biomechanical failure that provides tension along the plantar fascia.
Risk factors that cause damage to the plantar fascia include excessive foot pronation, jogging, obesity, prolonged standing, and inadequate ankle dorsiflexion. Limited ankle dorsiflexion, a body mass index higher than 27 kg per m2 and spending the most of the workday on one's feet are risk factors for developing plantar fasciitis in non-athletes. The most common symptom is painful medial plantar heel pain in the first few steps after sitting or sleeping. The pain usually goes away after further ambulation, but it can return with continued weightbearing.
Traditionally, it was believed that plantar fasciitis is induced by mechanical damage in which the plantar fascia was subjected to excessive tensile strain, which caused tiny tears and persistent inflammation. According to current theories, plantar fasciitis develops through a deterioration of fascia, which is why it is sometimes referred to as Fasciosis rather than Fasciitis, where maximum stress is the main factor in the etiology. Gap junctions between fibrocytes specifically perceive the increased fascial stress, which subsequently mediates alterations in the extracellular matrix, leading to myxoid deterioration and breakage of the plantar fascia.
Among the conservative therapy approaches for Plantar Fasciitis (PF) include activity modification, ice massage, stretching exercises, orthotics, oral analgesics, and corticosteroid injections. Low-level laser therapy, ultrasound therapy, and extracorporeal shockwave therapy (ESWT) are further treatment options for chronic plantar fasciitis (LLLT). Clinicians commonly employ a form of manual treatment called soft tissue mobilization/manipulation (STM) to lessen the pain and dysfunction brought on by musculoskeletal disorders. 87% of doctors use manual therapy on a daily basis. Instrumental Assisted Soft Tissue Mobilization (IASTM's) myofascial restriction, which is based on James Cyriax's soft tissue mobilization, gained increased attention recently. It has been proposed that IASTM acts as a neuromodulatory factor in pain regulation by activating mechanosensitive neurons found in the soft tissues that have been treated. The deformation of the skin may result in a reduction in the activity of fiber neurons, potentially producing an analgesic effect.
KT is an elastic therapeutic taping tool consisting of mainly of cotton, introduced by Dr. Kenso Kase in 1970s. It is lightweight, waterproof, breathable, and available in wide range of colors, types, lengths, textures. These features allow for multiple day wear and a constant pulling force on the skin. This pulling force to the skin on which kinesiotape is applied is thought to improve blood and lymphatic circulation, resulting in pain and edema relief. Following assessments and instructions from healthcare professionals, KT can be directly fixed to target tissue with combination of cuts (e.g. Y, I, X tape), tensions (% of stretch) and directions (e.g. muscle insertion to origin). Wearing KT maintain effect for 3-5 days, ideally following the 24 hours application rule based on skin condition. KT's therapeutic effects include increasing subcutaneous space, stimulating skin sensory receptors, supporting mechanical behavior, promoting micro circulation, and relieving pain in musculoskeletal disorders, improving proprioception stability, range of motion, and quality of life.
Previous studies have primarily focused on the effectiveness of Kinesio tapping solely on pain, function and quality of life in plantar fasciitis. In the past study, it was suggested to use conventional therapy along with Kinesio tape. Conventional therapies aim to alleviate pain, reduce inflammation and restore normal function. Thus, investigating the effectiveness of combining conventional therapy with Kinesio tapping in improving foot function and QOL in patients with plantar fasciitis. This research aims to fill the existing gap in literature by providing evidence-based guidance on optimal management approach for plantar fasciitis.This study will contribute in describing that which technique is best in management of plantar fasciitis and define the effects of both techniques on improving functional status and QOL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IASTM Group | Experimental | Other: IASTMInstrumental Assisted Soft Tissue Mobilization |
| KT Group | Experimental | Other: KT groupKinesiotaping |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both genders
- Age Range of 20-40 years
- Standing > 8 hours a day
- Positive Windlass test
- Patients who experience pain on medial tuberosity of the calcaneus on palpation.
Key exclusion criteria (4 listed)
- History of ankle or foot surgery
- Patients with inflammatory conditions like cancer, rheumatoid arthritis, ankle and foot bursitis.
- Foot related complications after fracture
- Patients receiving corticosteroid injections
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 |
|---|---|---|
| IASTMGraston therapy-8 min per session Procedure: The patient will be lying down with their knee bent 30 degrees. After a 5-minute ultrasound treatment and static stretching exercises.Treatment will be administered using the Graston tool (using the sweep approach). Applying a moderate amount of effort from the medial side of the heel to the metatarsals and from the metatarsals to the medial side of the heel, to-and-fro stroking at a 60° angle will be done on the sole of the foot for approximately eight minutes (60-70 strokes per minute with a 5- to 10-second rest interval. A cold pack will be used for five minutes after therapy. The GT session will last approximately 30 minutes. Conventional Therapy: Therapeutic ultrasound for 5 min Stretching of plantar fascia 5 reps with 10 sec hold) Cold therapy for 5 min Functional status and Quality of Life (QOL) will be assessed before and after treatment of 4 weeks using using tools. Intervention will be conducted once a week for 4 weeks. | Other | IASTM Group |
| KT groupKinesio tapping (left there for 3 days) Procedure: We will use a standard 2" (5 cm) kinesiology tape. Fascia tape will be applied to the plantar fascia, and it will be left there for three days. For four weeks, it will be applied once a week. The patient will be in a prone position, lying with the ankle joints in a neutral position while applying tape. With the toes extended against the bed or ground. The tape will be marked on the Achilles tendon. It will be cut longitudinally into five slices of equal width. It will be applied to the forefoot by stretching it by 25%. The last strap will be applied with gentle compression across the bases of the five slices beneath the foot and wrapped around the rear foot.(5) Conventional Therapy Therapeutic ultrasound for 5 min Stretching of plantar fascia 5 reps with 10 sec hold) Cold therapy for 5 min | Other | KT Group |
Primary outcome
Foot and Ankle Outcome Score (FAOS):
Time frame: 4 weeks
FAOS is a 42-item questionnaire divided into 5 subscales pain (9 items), other symptoms (7 items), ADL (17 items), sport/recreation (5 items) and quality of life (4 items). A five-point Likert scale, with 0 denoting no problem, 1 mild, 2 moderate, 3 severe, and 4 extreme problems, is used to grade each item. Each subscale's total score is summed together and divided by the subscale's maximum score, to determine the score for each subscale. A scale of 0 to 100 is created from the normalized score, where 100 represents no problems and 0 represents severe problems.
SF-12
Time frame: 4 weeks
A short health survey-12 version 2 is used to measure quality of life (SF-12 V.2). The patients' overall health and quality of life will be assessed using this questionnaire. There are twelve questions on the assessment form, and the answers can be used to score eight different areas of health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less on the PCS-12 has been recommended as a cut-off to determine a physical condition; while a score of 42 or less on the MCS-12 may be indicative of 'clinical depression'. There are two categories on the SF-12 V.2 surveys: Mental and Physical health. Cronbach's alpha values, which ranged from 0.60 to 0.87, supported the dependability and internal consistency.
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 13 Nov 2024.
- Background: PubMed 30302189Zhang J, Nie D, Rocha JL, Hogan MV, Wang JH. Characterization of the structure, cells, and cellular mechanobiological response of human plantar fascia. J Tissue Eng. 2018 Oct 3;9:2041731418801103. doi: 10.1177/2041731418801103. eCollection 2018 Jan-Dec.
- 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.
Shumaila Parveen, MS-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 IASTM and KT group in people with Plantar Fascitis, 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 6 inclusion and 4 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 13 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 Dr. Amman Ullah Nazir, PhD* (0333 5330065, aman.nazir@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and Ankle Outcome Score (FAOS): (time frame: 4 weeks). The study lists 2 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 NCT06686706, which also lists 1 linked publication.
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 13 Nov 2024.