NCT04162262

Effects of Exercise Versus Exercise and Instrument-Assisted Soft Tissue Mobilization for Plantar Fasciopathy Treatment

Immediate and 12-week Effects of Exercise Versus Exercise and Instrument-Assisted Soft Tissue Mobilization for Plantar Fasciopathy Treatment: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Texas Tech University Health Sciences Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study compares the addition instrument-assisted soft tissue mobilization (IASTM) to a program of home strengthening and stretching exercises to see whether adding weekly IASTM treatments improves plantar fasciopathy pain and plantar fascia stiffness.

Detailed description

Plantar fasciopathy (PF) is the most common cause of inferior heel pain, and approximately 40% of patients report symptoms two years following initial diagnosis. Exercise therapy, including gastrocnemius and plantar fascia stretching, and high-load strengthening have been shown to improve plantar fascia pain and function; however, not everyone improves with these interventions, and they require several weeks or months to be effective. The addition of instrument-assisted soft tissue mobilization (IASTM) techniques may improve these outcomes. Moreover, shear wave elastography (SWE) is an imaging technology that may provide helpful information regarding PF diagnosis and prognosis. Therefore, research is required to investigate changes in plantar fascia stiffness following exercise and IASTM interventions. This study is divided into two Parts. Part I is a parallel-group, pre-test post-test randomized controlled superiority trial comparing the long-term effects of stretching and strengthening exercises (SS) (Group 1, n=35) versus SS plus IASTM (SS+IASTM, Group 2, n=35) in subjects with PF. The study is approved by the local Intuitional Review Board. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for reporting of randomized interventional trials will be followed. Exercise interventions will be reported according to the Consensus on Exercise Reporting Template (CERT) guideline. Part II is a pre-test, post-test comparison of the short-term effects of IASTM on PF. Subjects from Group 2 of Part I (n=35) and a age and sex-matched healthy comparison group (Group 3, n=35) will participate in Part II. Random group allocation into SS and SS+IASTM Groups will be performed by an independent statistician using the R Statistics package using a 1:1 allocation ratio with permuted block sizes of 2 to 6. Although it is not possible to blind study participants, the investigators performing the weekly interventions and measurements will be blinded to the subjects' group allocation. After randomization subjects will receive a booklet that describes their condition and contains exercise instructions and an exercise training and medication usage diary. Group 1 will receive a sheet listing evidence for the beneficial effects of stretching and high-load strengthening. Group 2 will additionally receive information regarding the hypothesized benefits of IASTM. After group allocation and reading the appropriate booklet, subjects will complete the Credibility/Expectancy Questionnaire (CEQ), which contains six items requiring subjects to rate the credibility of the intervention and their expectations. Both groups will perform an identical exercise program but will additionally receive once weekly IASTM treatments over an 8-week period. The weekly and total treatment time in Groups 1 and 2 will be the same, 15 minutes/week for 8 weeks. Group 3 (Comparison Group) will be recruited in clusters of five after every 5 subjects are recruited into Group 2 (SS+IASTM) and will be matched to that group's age and BMI. Overall, subjects in Groups 1 and 2 will visit the lab 10 times. First, they will attend eight weekly sessions, which will include initial screening tests and exercise education on visit 1, treatments according to group allocation on visits 1-8, and follow-up testing on visits 5, 9, and 10. Both groups will additionally perform daily stretching and strengthening exercises at home. Between sessions 9 and 10 (i.e., weeks 9-11), these subjects will be contacted via telephone for follow-up testing and encourage continued home exercise program compliance. Group 3 will attend one session. This session will include screening tests before and after one IASTM treatment. Data will be summarized in descriptive statistics such as mean (standard deviation), median (interquartile range), and frequencies (percentage) as appropriate depending on the variable levels of measurement. Associations among categorical variables will be assessed using Chi-square or Fisher's exact test. Associations among continuous or ordinal level variables will be assessed using appropriate parametric or non-parametric correlation tests. Differences among demographic groups on continuous baseline variables will be assessed using t-test and ANOVA or their non-parametric alternatives (Mann-Whitney or Kruskal Wallis tests) where appropriate. The examined data in this study are clustered (nested) in nature. For example, the Foot Health Status, a dependent variable which is measured for both groups (the SS and SS + IASTM) through different subscales including pain subscale, function subscale, footwear subscale, and general foot health subscale (level 1), at different time points (level 2), within each individual participant (level 3). Therefore, linear mixed modeling is a suitable analytical technique to handle the data and answer research questions. Since the levels of the examined factors in the study constitute all the levels of interest for statistical inference, a covariance pattern fixed effects model that accounts for the covariance and correlational patterns among repeated measures could be the most suitable for this study to be utilized (among other different Mixed Model approaches that would be tested and implemented).

Conditions

• Plantar Fascitis

Interventions

Type	Name	Description
OTHER	Instrumental-assisted soft tissue mobilization (IASTM)	Instrumental-assisted soft tissue mobilization (IASTM) will consist of treatment focused on the plantar surfaces of foot, posterior heel, and lower leg. The IASTM will be implemented using Graston Technique Instruments by clinicians trained and certified in the technique. Each 10-minute treatment will consist of two phases: 1) six-minute static phase, which includes tissue status screening and soft tissue mobilization, and 2) four-minute dynamic tissue mobilization phase. The treatment will focus on the web spaces of each toe plantarly, the metatarsal heads, the spaces between metatarsals, the medial and lateral plantar fascia borders, plantar fascia proximal origin, the heel, and the lower leg muscle groups. The targeted soft tissues are the plantar fascia, ankle plantar flexors, heel fat pad, Achilles tendon, and the gastrocnemius-soleus complex.
OTHER	High-Load Strength Training	Participants will perform a heel raise exercise used by Rathleff et al (2015). The exercise will be performed twice daily. While standing with the forefoot on a step, the toes will rest on a partially folded towel, placing them in a maximally dorsiflexed position. The exercise will consist of a maximum ankle plantar flexion followed by maximal dorsiflexion. The concentric plantar flexion and eccentric lowering phases will be 3 seconds, with a 2 second isometric pause in between. The exercise will be performed unilaterally if tolerated by the subject. Otherwise, a bilateral calf raise will be performed until the subject is able to perform the unilateral version. The exercise will be performed every other day and progressed throughout the trial as described by Rathleff and colleagues.
OTHER	Plantar Flexor and Gastrocnemius Stretching	For the plantar flexor stretch (DiGiovanni et al, 2006), subjects will sit and cross the affected leg over the contralateral leg. Placing the affected side fingers on the plantar toes, distal to the metatarsophalangeal joints, they will passively dorsiflex the toes until they feel stretching in the arch of the foot. Subjects will be instructed to hold this stretch for 10 seconds and repeat it 10 times. The gastrocnemius stretch will be performed in supine with a towel placed around the distal foot and the foot actively inverted. With the knee extended, the subject will flex the hip while passively dorsiflexing the foot using the towel. This stretch will be held for 30 seconds and repeated 3 times. Subjects will be asked to perform both stretches three times each day.

Timeline

• Start date: 2019-10-24
• Primary completion: 2021-01-15
• Completion: 2021-01-15
• First posted: 2019-11-14
• Last updated: 2021-02-05

Locations

1 site across 1 country: United States