Clinical trial NCT06707844: TF and MFR on Calf Muscles in Patients With Pes Planus
Official title: Comparison of Tissue Flossing and Myofascial Release on Calf Muscles in Patients With Pes Planus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pes Planus
Keywords: tissue flossing
Flatfeet
myofascial release
balance
arch height
range of motion
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pes planus, commonly known as flat feet, is a condition characterized by a reduced or absent arch in the foot, which often leads to pain and functional limitations. This study aims to evaluate the effectiveness of two therapeutic interventions-tissue flossing and myofascial release-in improving balance, arch height, and range of motion (ROM) in patients with flexible flatfoot. The research will be conducted at the Margalla Rehabilitation Center over a duration of six months, involving a total of 44 participants divided into two equal groups. One group will receive tissue flossing as the intervention, while the other group will undergo myofascial release. Participants will be selected using non-probability convenience sampling. Eligible individuals will be adults aged 18-25 years with flexible pes planus and limited ankle dorsiflexion. The study seeks to provide valuable insights into the comparative effectiveness of these interventions for managing symptoms associated with flat feet. Data was be analyzed through SPSS version 25.

Detailed description: Pes planus, or flat feet, is characterized by a reduced or absent arch, causing the entire sole to contact the ground. It is categorized into flexible and rigid types, with flexible pes planus being more common. In this form, the arch is visible in non-weight-bearing positions but flattens during standing or walking, while rigid pes planus remains flat irrespective of weight-bearing. The condition often results in foot instability, excessive eversion, and midfoot abduction, leading to pain, fatigue, and reduced shock absorption during activities.

Flexible flatfoot is prevalent in children but can persist into adulthood, affecting 2% to 23% of adults in the U.S. and 13.6% in India. It disrupts gait mechanics, shifting weight medially, impairing balance, and increasing injury risk. Management ranges from conservative treatments like physical therapy to surgical interventions in severe cases.

Emerging therapies include tissue flossing and myofascial release (MFR). Tissue flossing uses compression bands to improve blood flow, reduce pain, and enhance range of motion (ROM). In contrast, MFR applies sustained pressure to relieve fascial tension, promoting flexibility and reducing discomfort. Both techniques show promise for addressing the biomechanical and functional impairments associated with pes planus.

Literature review: According to literature, Galis et al. (2022) performed a study that aimed to examine the effects of applying tissue flossing band at different pressure levels on ankle ROM, strength and power performance in university students. The results showed an increase in dorsiflexion ROM and power. Furthermore, the author concluded that this can aid injury prevention, performance enhancement, and functional ability.

In another study, Driller et al. (2016) conducted a study on the effects of tissue flossing on ankle ROM and jump performance in recreational athletes. The study concluded that applying floss bands to the ankle effectively increased both dorsiflexion and plantarflexion ROM and enhances single-leg jump performance in recreational athletes.

Similarly, Choi et al. (2022) conducted a study aimed at investigating the impact of myofascial release of the peroneus longus muscle on the activity of the abductor hallucis muscle and the medial longitudinal arch in individuals with flexible pes planus. The results showed an increase in abductor hallucis muscle activity and elevation of the medial longitudinal arch.

A study conducted by Chang et al. (2021) examined the effect of a single session of tissue flossing on the knee joint in female college students. The results showed a significant improvement with a medium-to-large effect in the Y-Balance test assessment immediately postintervention. He concluded that tissue flossing can indeed enhance dynamic balance.

Eligibility criteria: Inclusion Criteria:

* Age 18-25 years.
* Having normal BMI ranging from 18.5 to 24.9 kg/m²
* Having flexible flat feet, defined as a navicular drop test value of ≥10 mm
* Must have pain in the calf muscles or ankle joint, with a NPRS score of ≥3
* Must have limited ankle dorsiflexion ROM, defined as ≤10° of dorsiflexion

Exclusion Criteria:

* Patients with rigid flatfoot
* History of ankle or calf muscle injury or surgery within the last 6 months
* Individuals with latex allergy
* Individuals having any lumbo-pelvic, hip, knee and ankle pathologies such as fractures, dislocations, degenerative diseases etc.
* Any neurological disease
* Pregnant females
* Individuals with BMI greater than or equal to 25.0 kg/m²
* Ongoing use of medications such as muscle relaxants or anti-inflammatory drugs
* Involved in athletic training

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 3 weeks
Secondary outcomes:
measure: Digital Goniometer
timeFrame: 3 weeks
measure: Brody's Navicular Drop Test
timeFrame: 3 weeks
measure: Single-Leg Stance Test
timeFrame: 3 weeks
measure: Y-Balance test
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Margalla Rehabilitation Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Aneela Zia, MsOMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1. R A, Malar A, J H, G S. The cause and frequency of PES Planus (Flat Foot) problems among young adults. Asian Journal of Medical Sciences. 2021;12(7):107-11.