Temporal Differences in Pain, Muscle Stiffness, and Function in Subjects With Plantar Fasciitis After Myofascial Release Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Morning pain intensity measured with the Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
Plantar fasciitis (PF) is a common condition in the population. One of the interventions used to resolve this condition is myofascial release (MR), which consists of massages that help reduce pain and increase mobility. MR has shown efficacy when applied for 30 minutes, however, it is necessary to compare it with a 15-minute MR intervention, since in clinical practice optimizing time is essential. Accordingly, the present research seeks to evaluate whether there are differences in the application time of myofascial release in people with PF.
详细描述
Plantar fasciitis (PF) is an acute inflammation of the fascia resulting from degenerative irritation from the median tuberosity of the heel bone to surrounding perifascial structures. Histological findings include granulation tissue, microtears, collagen disorders, and in particular a lack of normal inflammation. It is one of the most common causes of musculoskeletal pain, with a population prevalence in adults aged 50 years or older of 9.6% (95% CI: 8.8 to 10.5) and a population prevalence of disabling pain of 7.9% (95% CI: 7.1 to 8.7), slightly more present in women than in men, with a history of knee, hip, and back pain. It is characterized by pain on the first step and pain during weight-bearing tasks, particularly after periods of rest. Among the possible low-cost and noninvasive treatments that have shown efficacy Manual therapy (MT) is a popular treatment for PF. TM includes treatments such as joint and soft tissue mobilizations, manipulations, myofascial trigger point release, and stretch-contraction-relaxation. In particular, myofascial release is a gradual soft tissue stretching by the clinician that is guided entirely by feedback from the recipient's body to determine the direction, strength, and duration of the stretch to address specific soft tissue restrictions.
TM has been frequently used to treat PF, systematic reviews have reported positive results on pain, function, and pressure pain threshold, but suggest that they should be viewed with caution due to poor methodological quality, intervention heterogeneity in dosing (frequency, intensity, and duration), techniques, and outcome measures, and the frequent use of secondary manual therapy co-interventions. The application of myofascial release is varied in the number of procedures, application time of each technique and total application time of the intervention, without a clear justification regarding the decision of each of these options. A clinical trial applied a protocol for 4 weeks, where each session was performed in 30 minutes, and demonstrated that myofascial release is more effective than the control group, presenting a change in the average pressure pain threshold of 1.3 kg/cm2 at the end of the 4-week treatment. This change is considered clinically important, given that in the literature it has been reported that this difference is > 1.16 kg/cm2. However, the reason for the time used, the number of techniques and the choice of techniques is not justified. In addition, there are no investigations in the literature on the specific effect of myofascial release with a shorter application time in PF. On the other hand, studies with deep massage, a manual therapy technique, combined with flexibility exercise has proven to be effective with an execution time of 10 minutes. Under this context and considering that in clinical practice the optimization of times is essential, it is relevant to carry out a clinical equivalence trial that allows to determine the efficacy of isolated myofascial release in PF, with a 30-minute intervention protocol already carried out and that demonstrated positive effects on the pressure pain threshold, contrasted with a time of less than 15 minutes. Given the context raised, the question arises: In participants with plantar fasciitis, would the application of a myofascial release treatment for 15 minutes have equivalent effects to myofascial release applied for 30 minutes, in the pain and stiffness of the gastrocnemius muscle?
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study participants must be diagnosed with PF
- •Age between 18 to 60 years a clinical diagnosis of unilateral PF according to the clinical practice guidelines of the orthopedic section of the American Physical Therapy Association (APTA).
- •Pain intensity > 2 on the numerical pain rating scale (NPRS).
- •Pain that is most intense upon awakening and decreases during walking. • Duration of pain greater than 3 months and less than 7 months.
- •Both sexes.
排除标准
- •Who have received ankle or foot interventions within the previous three months, such as physical therapy (manual therapy, exercise, physical agents), injections, long-term history of steroid use.
- •History of surgery on the ankle, foot, or inner leg.
- •Other causes of heel pain: arthritic (fibromyalgia, gout, rheumatoid arthritis, seronegative spondyloarthropathies), infectious (diabetic ulcers, osteomyelitis, plantar warts), neurological (lumbar radiculopathy (L4-S2), nerve entrapment (branches of posterior tibial nerve), neuroma, tarsal tunnel syndrome, (posterior tibial nerve), trauma (calcaneal stress fracture), tumor (Ewing's sarcoma, neuroma), vascular and pregnancy.
结局指标
主要结局
Morning pain intensity measured with the Numeric Pain Rating Scale (NPRS)
时间窗: It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment
The Numeric Pain Rating Scale (NPRS) measures pain intensity from 0 to 11 points (0, no pain; 10, worst pain imaginable).(18) Numeric pain scales have been shown to be reliable and valid.(25) In addition, the DCMI (minimally clinically important difference) has been reported to be 2 points.(26)
次要结局
- Pressure pain threshold (PPT)(It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment)
- Calf muscle stiffness (Silfverskiöl test)(It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment)
- Functionality (Foot Function Index (FFI))(It will be measured at Baseline, up to 15 min after the first session, at 4 weeks and at 4 weeks after the end of the treatment)
- Health-related quality of life (SF-12)(It will be measured at Baseline, at 4 weeks and at 4 weeks after the end of the treatment)
- Perception of change (Patient Global Impression of Change)(It will be measured at at 4 weeks and at 4 weeks after the end of the treatment)
- Foot health (Foot Health Status Questionnaire (FHSQ)(It will be measured at Baseline, at 4 weeks and at 4 weeks after the end of the treatment)
研究者
Ignacio Gajardo Valenzuela
Principal Investigator
Universidad Católica del Maule