An interventional study of Exercises in Trochanteric Bursitis, sponsored by Universidade Estadual de Londrina. Status unknown at 1 site in Brazil. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by Universidade Estadual de Londrina · Not applicable, Interventional, and Treatment
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.
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:
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.
411 studies on the registry are indexed under Bursitis; 112 are open to participants now.
This study's planned enrollment of 26 is below the median of 45 across 371 interventional studies indexed under Bursitis.
Browse Bursitis studies →Universidade Estadual de Londrina is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
PHASE I: (sessions 1 to 4) 1. Active exercise without weight support (standing) for abductors, adductors, hip flexors and extensors 2. Hip extension exercise in 4 supports 3. Hip abduction exercise in 4 supports ("hydrant") 4. Oyster Exercise 5. Hip abduction exercise in lateral decubitus 6. Hip extension exercise in ventral decubitus PHASE II: (sessions 5 to 8) 1. Hip abduction exercise in lateral decubitus 2. Progressive resistance exercise for abductors, adductors, flexors and hip extensors with standing theraband 3. Side walk with theraband positioned at the ankle joint 4. Squat exercise 5. Advance exercise 6. Step down exercise
Other: Exercises
In addition to all the exercises in the "hip exercise" group, this group will do: PHASE I: (sessions 1 to 4) 1. Exercise for contraction of the transversus abdominais in the supine position 2. Bridge exercise 3. Plank exercise PHASE II: (sessions 5 to 8) 1. Unilateral bridge exercise 2. Plank exercise with hip extension 3. Lateral plank exercise
Other: Exercises
There will be 2 reevaluations of the participants, similar to the initial: at the end of the exercise protocol and in a follow-up of 12 weeks after the end of the protocol. The contraction phase of each exercise will be 2 concentric seconds, 1 isometric second and 2 eccentric seconds, followed by 1 second of rest; there will be approximately 90 seconds of rest between each set of 10 repetitions, time the other member will be exercising. At the beginning and at the end of each session, the participants will be asked to point out the pain they feel in the hip at that time. In each of the 8 sessions, the physiotherapist will take note of the presence, lateral pain in the hip at the beginning and end of the therapy (by VAS), number of repetitions performed in each exercise (for the group that will do core exercises, it will be noted the time in seconds of each exercise) and any adverse events. Each series of exercises will be repeated 3 times, all performed bilaterally.
initial postural control
The center of pressure oscillation will be evaluated (COP). The results will be presented in cm2.
Time frame: before starting treatment
Postural control after treatment
The center of pressure oscillation will be evaluated (COP). The results will be presented in cm2.
Time frame: immediately after the end of treatment
Postural control after 12 weeks
The center of pressure oscillation will be evaluated (COP). The results will be presented in cm2.
Time frame: 12 weeks after the end of treatment
initial Muscle Ativation
Muscle activation will be evaluated by surface electromyography and presented in RMS.
Time frame: before starting treatment
Muscle Ativation after treatment
Muscle activation will be evaluated by surface electromyography and presented in RMS.
Time frame: immediately after the end of treatment
Muscle Ativation after 12 weeks
Muscle activation will be evaluated by surface electromyography and presented in RMS.
Time frame: 12 weeks after the end of treatment
change in hip function
In each assessment, participants will respond to the Hip Outcome Score (HOS). The Hip Outcome Score (HOS) is an instrument capable of evaluating physically active patients with hip diseases, without severe degenerative changes. Higher scores mean better functionality. The HOS is a self-administered questionnaire, which has 28 items (questions) divided into two subscales, one for Activities of Daily Living (ADL), with 19 items; and another for Sport, with nine items. Each subscale can vary the final score (score) between 0 and 100, with higher scores representing better hip function.
Time frame: evaluation before treatment, immediately at the end of treatment and after 12 weeks
change in severity of Symptoms
at each assessment, participants will respond to the VISA tendinopathy questionnaire for greater trochanteric pain syndrome, the VISA-G. It consists of eight questions that assess current symptoms with total scores ranging from 0 to 100, with higher scores indicating less pain and better function.
Time frame: evaluation before treatment, immediately at the end of treatment and after 12 weeks
change in Core Strenght
The time spent in the Prone Bridge Test (in the prone position) will be evaluated in seconds.
Time frame: evaluation before treatment, immediately at the end of treatment and after 12 weeks
change in Muscle Strenght
The muscular strength of abductor groups, adductors, internal rotators, hip flexors and extensors will be quantified in kilograms, accessed by load cell. The results will be presented in kilograms.
Time frame: evaluation before treatment, immediately at the end of treatment and after 12 weeks
change in pain intensity
the intensity of your pain using the Visual Analog Pain Scale (VAS), which scores your current pain with scores between 0 and 10. Zero is no pain and 10 is considered unbearable pain
Time frame: evaluation before treatment, immediately at the end of treatment and after 12 weeks
Plan to share: No — There is not a plan to make IPD available.
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Universidade Estadual de Londrina