Clinical trial NCT05662579: Core Resistance and Lateral Hip Pain
Official title: Effect of a Core Muscle Resistance Program on Great Trochanteric Pain Syndrome (GTPS): Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trochanteric Bursitis
Keywords: lateral hip pain
trochanteric bursitis
gluteus medius tendinosis
greater trochanteric gluteal syndrome
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 26
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized blind clinical trial, with a longitudinal characteristic in the area of physiotherapy, orthopedics, postural control and biomechanics. The intervention will consist of 4 weeks, 2 times a week, and the variables of interest will be measured in the pre-treatment period, after 4 weeks (immediately after the end of the protocol) and in the follow up of 12 weeks after the end of the protocol.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: initial postural control
timeFrame: before starting treatment
measure: Postural control after treatment
timeFrame: immediately after the end of treatment
measure: Postural control after 12 weeks
timeFrame: 12 weeks after the end of treatment
measure: initial Muscle Ativation
timeFrame: before starting treatment
measure: Muscle Ativation after treatment
timeFrame: immediately after the end of treatment
measure: Muscle Ativation after 12 weeks
timeFrame: 12 weeks after the end of treatment
Secondary outcomes:
measure: change in hip function
timeFrame: evaluation before treatment, immediately at the end of treatment and after 12 weeks
measure: change in severity of Symptoms
timeFrame: evaluation before treatment, immediately at the end of treatment and after 12 weeks
measure: change in Core Strenght
timeFrame: evaluation before treatment, immediately at the end of treatment and after 12 weeks
measure: change in Muscle Strenght
timeFrame: evaluation before treatment, immediately at the end of treatment and after 12 weeks
measure: change in pain intensity
timeFrame: evaluation before treatment, immediately at the end of treatment and after 12 weeks
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: State University of Londrina
state: PR
Study officials:
References:
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