Core Resistance and Lateral Hip Pain

NCT ID: NCT05662579

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-07-30

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.

Conditions

Trochanteric Bursitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

hip exercises

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

Group Type: EXPERIMENTAL

Exercises

Intervention Type: OTHER

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.

hip + core 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

Group Type: EXPERIMENTAL

Exercises

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade Estadual de Londrina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

State University of Londrina

Londrina, Paraná, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Christiane Macedo, PhD

Role: CONTACT

chmacedo@uel.br

+5543991015123

Christiane Macedo

Role: CONTACT

chmacedo@uel.br

+5543991015123

Facility Contacts

Christiane DSG Macedo

Role: primary

chmacedouel@yahoo.com.br

43991015123

References

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Reference Type: BACKGROUND

PMID: 18560185 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 22983121 (View on PubMed)

Marshall PW, Murphy BA. Core stability exercises on and off a Swiss ball. Arch Phys Med Rehabil. 2005 Feb;86(2):242-9. doi: 10.1016/j.apmr.2004.05.004.

Reference Type: BACKGROUND

PMID: 15706550 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 28263673 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 24787333 (View on PubMed)

Reid D. The management of greater trochanteric pain syndrome: A systematic literature review. J Orthop. 2016 Jan 22;13(1):15-28. doi: 10.1016/j.jor.2015.12.006. eCollection 2016 Mar.

Reference Type: BACKGROUND

PMID: 26955229 (View on PubMed)

Del Buono A, Papalia R, Khanduja V, Denaro V, Maffulli N. Management of the greater trochanteric pain syndrome: a systematic review. Br Med Bull. 2012 Jun;102:115-31. doi: 10.1093/bmb/ldr038. Epub 2011 Sep 4.

Reference Type: BACKGROUND

PMID: 21893483 (View on PubMed)

Rompe JD, Segal NA, Cacchio A, Furia JP, Morral A, Maffulli N. Home training, local corticosteroid injection, or radial shock wave therapy for greater trochanter pain syndrome. Am J Sports Med. 2009 Oct;37(10):1981-90. doi: 10.1177/0363546509334374. Epub 2009 May 13.

Reference Type: BACKGROUND

PMID: 19439758 (View on PubMed)

Other Identifiers

Resistência do core no quadril

Identifier Type: -

Identifier Source: org_study_id