Clinical trial NCT06686706: Effects of IASTM and Kinesiotaping in Plantar Fascitis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plantar Fascitis
Keywords: Plantar Fascitis
IASTM
Graston technique
Kinesio Taping
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Foot and Ankle Outcome Score (FAOS):
timeFrame: 4 weeks
measure: SF-12
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Bahria Active
state: Punjab
Study officials:
affiliation: Riphah International University
name: Shumaila Parveen, MS-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.