Immediate and 12-week Effects of Exercise Versus Exercise and Instrument-Assisted Soft Tissue Mobilization for Plantar Fasciopathy Treatment: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- The Foot Health Status Questionnaire Pain Subscale Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Random group allocation into Groups 1 and 2 will be performed using a 1:1 allocation ratio with permuted block sizes of 2 to 6. The investigators responsible for the weekly progression of the stretching and strengthening exercise protocol and the outcome assessor will be masked to the participants' assigned groups. The investigators providing instrument-assisted soft tissue mobilization will not be blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Stretching, Strengthening, and 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.
干预措施: Plantar Flexor and Gastrocnemius Stretching (Other)
Stretching, Strengthening, and 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.
干预措施: Instrumental-assisted soft tissue mobilization (IASTM) (Other)
Stretching, Strengthening, and 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.
干预措施: High-Load Strength Training (Other)
Strengthening and 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.
干预措施: High-Load Strength Training (Other)
Strengthening and 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.
干预措施: Plantar Flexor and Gastrocnemius Stretching (Other)
Pain-free Comparison Group
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.
干预措施: Instrumental-assisted soft tissue mobilization (IASTM) (Other)
结局指标
主要结局
The Foot Health Status Questionnaire Pain Subscale Score
时间窗: Week 8
This self-report questionnaire assesses individuals' foot health and function. The pain subscale evaluates type of pain and its severity and duration.
次要结局
- Ankle range of motion(Baseline and weeks 4, 8, and 12)
- First metatarsophalangeal range of motions(Baseline and weeks 4, 8, and 12)
- Visual Analog Scale Pain Score(Baseline and weeks 4, 8, and 12.)
- The Foot Health Status Questionnaire Foot Function Subscale Score(Baseline and weeks 4, 8, and 12)
- Patient Acceptable Symptom State(Baseline and weeks 4, 8, and 12. Phone visits at weeks 9, 10, 11.)
- Credibility/Expectancy Questionnaire(Baseline visit)
- The Foot Health Status Questionnaire Footwear Subscale Score(Baseline and weeks 4, 8, and 12)
- The Foot Health Status Questionnaire General Foot Health Subscale Score(Baseline and weeks 4, 8, and 12)
- Plantar Fascia Shear Wave Velocity(week 0, 4, 8 and 12)
- Physical Activity Level(Baseline and weeks 4, 8, and 12)