Effects of Exercise Versus Exercise and Instrument-Assisted Soft Tissue Mobilization for Plantar Fasciopathy Treatment
- Conditions
- Plantar Fascitis
- Interventions
- Other: Instrumental-assisted soft tissue mobilization (IASTM)Other: High-Load Strength TrainingOther: Plantar Flexor and Gastrocnemius Stretching
- Registration Number
- NCT04162262
- Lead Sponsor
- Texas Tech University Health Sciences Center
- Brief 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stretching, Strengthening, and IASTM Instrumental-assisted soft tissue mobilization (IASTM) This group will attend eight weekly sessions, which will include initial screening tests and exercise education on visit 1 and strengthening and stretching exercise progression on visits 1-8. Data measurements will occur at weeks 0, 4, 8, and 12. This group will perform a 5-minute, self-paced warmup on a stationary bicycle followed by a 10-minute IASTM treatment. Test measurements will be performed before and immediately following the warmup and IASTM treatment. They will then perform stretching and strengthening exercises under the supervision of an investigator masked to treatment group weekly for eight visits. Exercise resistance will be increased as needed each week. In addition, participants will perform daily stretching and strengthening exercises at home. Stretching, Strengthening, and IASTM Plantar Flexor and Gastrocnemius Stretching This group will attend eight weekly sessions, which will include initial screening tests and exercise education on visit 1 and strengthening and stretching exercise progression on visits 1-8. Data measurements will occur at weeks 0, 4, 8, and 12. This group will perform a 5-minute, self-paced warmup on a stationary bicycle followed by a 10-minute IASTM treatment. Test measurements will be performed before and immediately following the warmup and IASTM treatment. They will then perform stretching and strengthening exercises under the supervision of an investigator masked to treatment group weekly for eight visits. Exercise resistance will be increased as needed each week. In addition, participants will perform daily stretching and strengthening exercises at home. Stretching, Strengthening, and IASTM High-Load Strength Training This group will attend eight weekly sessions, which will include initial screening tests and exercise education on visit 1 and strengthening and stretching exercise progression on visits 1-8. Data measurements will occur at weeks 0, 4, 8, and 12. This group will perform a 5-minute, self-paced warmup on a stationary bicycle followed by a 10-minute IASTM treatment. Test measurements will be performed before and immediately following the warmup and IASTM treatment. They will then perform stretching and strengthening exercises under the supervision of an investigator masked to treatment group weekly for eight visits. Exercise resistance will be increased as needed each week. In addition, participants will perform daily stretching and strengthening exercises at home. Strengthening and Stretching Plantar Flexor and Gastrocnemius Stretching This group will attend eight weekly sessions, which will include initial screening tests and exercise education on visit 1 and strengthening and stretching exercise progression on visits 1-8. Data measurements will occur at weeks 0, 4, 8, and 12. To equalize visit time with the Stretching, Strengthening, and IASTM group, subjects will perform 15 minutes of self-paced bicycle riding at the beginning of each session. They will then perform stretching and strengthening exercises under the supervision of an investigator masked to treatment group weekly for eight visits. Exercise resistance will be increased as needed each week. In addition, participants will perform daily stretching and strengthening exercises at home. Pain-free Comparison Group Instrumental-assisted soft tissue mobilization (IASTM) The third group is a pain-free comparison group. This group will come to the laboratory once. They will perform a 5-minute, self-paced warmup on a stationary bicycle followed by a 10-minute IASTM treatment. Test measurements will be performed before and immediately following the warmup and IASTM treatment. These measurements will be compared to the same measures from the Stretching, Strengthening, and IASTM group to examine outcome measure differences in those with and without plantar fasciopathy following a single IASTM treatment. Strengthening and Stretching High-Load Strength Training This group will attend eight weekly sessions, which will include initial screening tests and exercise education on visit 1 and strengthening and stretching exercise progression on visits 1-8. Data measurements will occur at weeks 0, 4, 8, and 12. To equalize visit time with the Stretching, Strengthening, and IASTM group, subjects will perform 15 minutes of self-paced bicycle riding at the beginning of each session. They will then perform stretching and strengthening exercises under the supervision of an investigator masked to treatment group weekly for eight visits. Exercise resistance will be increased as needed each week. In addition, participants will perform daily stretching and strengthening exercises at home.
- Primary Outcome Measures
Name Time Method The Foot Health Status Questionnaire Pain Subscale Score Week 8 This self-report questionnaire assesses individuals' foot health and function. The pain subscale evaluates type of pain and its severity and duration.
- Secondary Outcome Measures
Name Time Method Ankle range of motion Baseline and weeks 4, 8, and 12 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.
First metatarsophalangeal range of motions Baseline and weeks 4, 8, and 12 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.
Visual Analog Scale Pain Score Baseline and weeks 4, 8, and 12. Heel pain severity on a 10-cm scale when getting out of bed in the morning
The Foot Health Status Questionnaire Foot Function Subscale Score Baseline and weeks 4, 8, and 12 Evaluates the feet in terms of impact on physical function
Patient Acceptable Symptom State Baseline and weeks 4, 8, and 12. Phone visits at weeks 9, 10, 11. Self-reported time to achieve a satisfactory result.
Credibility/Expectancy Questionnaire Baseline visit 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.
The Foot Health Status Questionnaire Footwear Subscale Score Baseline and weeks 4, 8, and 12 Evaluates lifestyle issues related to footwear and the feet.
The Foot Health Status Questionnaire General Foot Health Subscale Score Baseline and weeks 4, 8, and 12 Evaluates participants' self-perception of their feet.
Plantar Fascia Shear Wave Velocity week 0, 4, 8 and 12 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.
Physical Activity Level Baseline and weeks 4, 8, and 12 Measured using the International Physical Activity Questionnaire short form (IPAQ), which estimates weekly physical activity.
Trial Locations
- Locations (1)
Texas Tech University Health Sciences Center
🇺🇸Lubbock, Texas, United States