Effect of a Core Muscle Resistance Program on Great Trochanteric Pain Syndrome (GTPS): Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Postural control after treatment
研究概览
简要总结
Although the middle gluteal muscle is an important stabilizer of the pelvis, no relationship has yet been described between the Great Trochanteric Pain Syndrome (GTPS) and the resistance of the core muscles. Objective: To evaluate the effect of a core resistance program on pain, activation and muscle strength, quality of life and postural control in women with GTPS. Materials and methods: The sample will consist of 36 postmenopausal women with clinical diagnosis of GTPS, who will be randomized into 2 groups: group 1 (hip exercises) and group 2 (hip + core exercises). The treatment protocol will be performed twice a week, for 4 weeks. The same evaluation will be done in 3 moments (in the pre-treatment period, after 4 weeks and 12 weeks after the end of treatment, as a follow up), and will consist of the following analyzes: quality of life (Hip Outcome Score - HOS questionnaire), GTPS severity (VISA-G questionnaire), muscle activation (electromyography - EMG), dynamic postural control (force platform - CoP), muscle strength (load cell), core resistance (supine bridge test and prone bridge test) and pain intensity (Visual Analogue Scale). Expected results: It is intended to establish the effect of a resistance program of core muscles on pain, activation and muscle strength, quality of life and postural control in women with SDGT.
详细描述
If a patient is using an anti-inflammatory, guided by the orthopedist, or a physiotherapy treatment protocol, start only 10 days after the end of the same. As participants, they will be instructed to avoid activities that cause pain during the research period. All others selected until the final evaluation will be discouraged. For all groups, the use of analytical medication prescribed by the orthopedist will be allowed, when requested. As the participants will be asked each session about the use of their analog, the data and the dosage that will occur during the study period will be noted. If necessary, how researchers will contact the orthopedist for information and guidance. If a participant needs to use anti-inflammatory medication during a survey, they will be excluded.
The analyzes will be carried out by a blind researcher regarding the allocation of the subjects in each group. Participants who have missing data and those who do not attend all treatment sessions will be included in the analysis.
To establish the results, the following variables will be considered:
- Pain intensity: VAS
- Quality of life: scores on the HOS questionnaire
- Severity of symptoms: VISA-G questionnaire
- Muscle activation: (peak of RMS) of the gluteus medius, gluteus maximus, spine erector, rectus abdominis, external oblique, internal oblique / transverse abdominal muscles
- Postural control: elliptical area of the center of pressure oscillation (COP), amplitude of oscillation of the COP and oscillation speed of the COP
- Muscle strength: measurements carried out by the load cell for the abductor, adductor, internal and external rotator groups, extensors, and hip flexors (in Kgf)
- Time (in months) reporting pain in the hip (sample characterization questionnaire)
- Presence or not of hip pain when lying in DL on it (questionnaire to characterize the sample)
- Hours of weekly physical activity (sample characterization questionnaire)
- Use or not of hormone replacement (sample characterization questionnaire)
The Shapiro-Wilk test will be applied to determine the normality of the sample. Student's t test will be used to compare age, weight, height, body mass index (BMI), duration of current illness, level of physical activity, use of hormone replacement and the presence of pain when lying on the hip between groups. The two-way ANOVA test (with Bonferroni post-test) will be used to compare the intra-group and intergroup results, if the data are normal, and will be described as mean and standard deviation. Cohen's D test will be performed to calculate the effect size. Linear correlation between variables will be investigated by Pearson's (or Spearman's) correlation test. If there is a linear correlation between any of the potentially confounding variables, analysis of covariance will be performed using the ANCOVA test. Other necessary analyzes may still be included. The level of statistical significance will be set at p ≤ 0.
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 (Investigator, Outcomes Assessor)
盲法说明
The evaluations of the participants and the analysis of the data will be carried out by a researcher blind to the allocation of the subjects in each group.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal status (amenorrhea for at least 12 months or hysterectomy)
- •lateral pain in the hip for at least 3 months
- •clinical diagnosis of GTPS performed by an orthopedist
排除标准
- •surgery on lower limbs or spine in the last 12 months
- •symptoms of osteoarthritis or intra-articular disease of the hip (joint block, limited range of motion and difficulty handling socks and clothes)
- •infiltration of the hip with corticosteroids in the last 6 months
- •have received physical therapy for this condition in the past 12 months
- •participants who need to use anti-inflammatory drugs
结局指标
主要结局
Postural control after treatment
时间窗: immediately after the end of treatment
The center of pressure oscillation will be evaluated (COP). The results will be presented in cm2.
initial Muscle Ativation
时间窗: before starting treatment
Muscle activation will be evaluated by surface electromyography and presented in RMS.
Postural control after 12 weeks
时间窗: 12 weeks after the end of treatment
The center of pressure oscillation will be evaluated (COP). The results will be presented in cm2.
Muscle Ativation after treatment
时间窗: immediately after the end of treatment
Muscle activation will be evaluated by surface electromyography and presented in RMS.
initial postural control
时间窗: before starting treatment
The center of pressure oscillation will be evaluated (COP). The results will be presented in cm2.
Muscle Ativation after 12 weeks
时间窗: 12 weeks after the end of treatment
Muscle activation will be evaluated by surface electromyography and presented in RMS.
次要结局
- change in Core Strenght(evaluation before treatment, immediately at the end of treatment and after 12 weeks)
- change in pain intensity(evaluation before treatment, immediately at the end of treatment and after 12 weeks)
- change in hip function(evaluation before treatment, immediately at the end of treatment and after 12 weeks)
- change in Muscle Strenght(evaluation before treatment, immediately at the end of treatment and after 12 weeks)
- change in severity of Symptoms(evaluation before treatment, immediately at the end of treatment and after 12 weeks)