Ignite Creation Date:
2024-05-06 @ 6:26 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05662579
Status:
RECRUITING
Last Update Posted:
2023-04-26
First Post:
2022-03-07
Brief Title:
Core Resistance and Lateral Hip Pain
Sponsor:
Universidade Estadual de Londrina
Organization:
Universidade Estadual de Londrina
Study Overview
Official Title:
Effect of a Core Muscle Resistance Program on Great Trochanteric Pain Syndrome GTPS Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GTPS
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 Students 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 Cohens D test will be performed to calculate the effect size Linear correlation between variables will be investigated by Pearsons or Spearmans 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
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 Students 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 Cohens D test will be performed to calculate the effect size Linear correlation between variables will be investigated by Pearsons or Spearmans 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None