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

Plantar Fascitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04162262
• Other study ID #: L19-147
• Status: Completed
• Phase: N/A
• Start date: October 24, 2019
• Est. completion date: January 15, 2021

Study information

• Verified date: February 2021
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria for Plantar Fasciopathy Groups

• age 18-60 years

• self-reported history of plantar heel pain for a minimum of 2 months prior to enrollment

• pain on palpation of the medial calcaneal tubercle or the proximal plantar fascia

• pain is worst when first standing or walking after rest

• willing to attempt not to use additional treatments (e.g., shoe modifications, foot orthoses/braces, injections, or surgery) during the trial period (12 weeks)

• willing to attempt to discontinue taking all pain-relieving medications except Tylenol or ibuprofen for plantar heel pain during the trial period (12 weeks).

Inclusion Criteria for Healthy Comparison Group:

• age and BMI matched with Group 2 subjects

• no history or symptoms of plantar heel pain in the past 12 months

Exclusion Criteria for all three groups:

• history of direct trauma to the foot with plantar fasciopathy

• inflammatory arthritis in the feet/ankle (e.g., ankylosing spondylitis or rheumatoid arthritis)

• metabolic or endocrine disorders (e.g., Type I or II diabetes)

• neurological disorders (e.g., Charcot-Marie-Tooth disease)

• prior foot surgery on the foot with plantar fasciopathy

• pregnancy (by self-report)

• corticosteroid injection to treat plantar fasciopathy in the past 12 weeks

• body mass index > 35 kg/m2

• receiving or applied for worker compensation benefits

• no physical activity above 5 (moderate activity) on a 10-point Rating of Perceived Exertion scale in the past 24 hours prior to the initial screening visit.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Foot Health Status Questionnaire Pain Subscale Score	This self-report questionnaire assesses individuals' foot health and function. The pain subscale evaluates type of pain and its severity and duration.	Week 8
Secondary	Ankle range of motion	Ankle dorsiflexion range of motion will be measured while the subject performs a weight-bearing lunge while facing a wall. Subjects will keep their heels on the ground and may keep contact on the wall in front of them with two fingers to maintain balance. The knee will be aligned with the second toe with the first toe 10 cm away from the wall. To perform the test, subjects will bring their knee forward towards the wall, keeping it aligned with the second metatarsal. If the knee contacts the wall while maintaining the heel on the ground, the foot will be moved back 1 cm at a time until the heel raises off the ground during the test performance. The final distance between the wall and the first toe will be recorded, and the test will be repeated three times.	Baseline and weeks 4, 8, and 12
Secondary	First metatarsophalangeal range of motions	First metatarsophalangeal (MTJ) joint range of motion will be measured using a 2D electrogoniometer (Noraxon Ultium, Scottsdale, AZ). The electrogoniometer will be placed along the ventral surface of the first metatarsal phalangeal joint. Subjects will stand with the feet shoulder-width apart. An investigator will lift the first toe and record dorsiflexion range of motion. No mid-foot or heel motion will be allowed during measurement. The range of motion will be measured three times.	Baseline and weeks 4, 8, and 12
Secondary	Patient Acceptable Symptom State	Self-reported time to achieve a satisfactory result.	Baseline and weeks 4, 8, and 12. Phone visits at weeks 9, 10, 11.
Secondary	Credibility/Expectancy Questionnaire	Participants self-rate the credibility of the intervention and their expectations for recovery after they are informed of their group allocation but prior to any intervention.	Baseline visit
Secondary	Visual Analog Scale Pain Score	Heel pain severity on a 10-cm scale when getting out of bed in the morning	Baseline and weeks 4, 8, and 12.
Secondary	Plantar Fascia Shear Wave Velocity	Ultrasound Shear Wave Elastography (Aixplorer, Axe-En-Provence, France, Version 10) will be used to measure plantar fascia shear wave velocity (m/s) at the 0.5 cm distal to the proximal calcaneal insertion and at the level of the navicular in the midfoot.	week 0, 4, 8 and 12
Secondary	The Foot Health Status Questionnaire Footwear Subscale Score	Evaluates lifestyle issues related to footwear and the feet.	Baseline and weeks 4, 8, and 12
Secondary	The Foot Health Status Questionnaire General Foot Health Subscale Score	Evaluates participants' self-perception of their feet.	Baseline and weeks 4, 8, and 12
Secondary	The Foot Health Status Questionnaire Foot Function Subscale Score	Evaluates the feet in terms of impact on physical function	Baseline and weeks 4, 8, and 12
Secondary	Physical Activity Level	Measured using the International Physical Activity Questionnaire short form (IPAQ), which estimates weekly physical activity.	Baseline and weeks 4, 8, and 12