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Trochanteric BursitisGTPSNCT05662579

Core Resistance and Lateral Hip Pain

A study testing Exercises in people with Trochanteric Bursitis, run by Universidade Estadual de Londrina at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years, women only
Conditions the study is for
Trochanteric Bursitis
What is being tested?
Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteBrazil
Study dates
1 Nov 2022to 30 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Christiane Macedo, PhD contact

+5543991015123

chmacedo@uel.br

Christiane Macedo contact

+5543991015123

chmacedo@uel.br

Brazil1 site, 1 recruiting
  • State University of Londrina

    Londrina, Paraná, 86041-263

    Christiane DSG Macedo, 43991015123, chmacedouel@yahoo.com.br

    Recruiting

Other trials in Brazil

About this study

Official title: Effect of a Core Muscle Resistance Program on Great Trochanteric Pain Syndrome (GTPS): Randomized Clinical Trial

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.

Read the 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.

Being tested
Exercises
Keywords
lateral hip pain, trochanteric bursitis, gluteus medius tendinosis, greater trochanteric gluteal syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExercisesOther

    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.

Study groups in NCT05662579
Study groupRoleWhat they receive
hip exercisesExperimentalPHASE 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
Receives: Other: Exercises
hip + core exercisesExperimentalIn 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
Receives: Other: Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. initial postural control

    The center of pressure oscillation will be evaluated (COP). The results will be presented in cm2.

    Measured: before starting treatment

  2. Postural control after treatment

    The center of pressure oscillation will be evaluated (COP). The results will be presented in cm2.

    Measured: immediately after the end of treatment

  3. Postural control after 12 weeks

    The center of pressure oscillation will be evaluated (COP). The results will be presented in cm2.

    Measured: 12 weeks after the end of treatment

  4. initial Muscle Ativation

    Muscle activation will be evaluated by surface electromyography and presented in RMS.

    Measured: before starting treatment

  5. Muscle Ativation after treatment

    Muscle activation will be evaluated by surface electromyography and presented in RMS.

    Measured: immediately after the end of treatment

  6. Muscle Ativation after 12 weeks

    Muscle activation will be evaluated by surface electromyography and presented in RMS.

    Measured: 12 weeks after the end of treatment

Secondary outcomes (5)
  1. 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.

    Measured: evaluation before treatment, immediately at the end of treatment and after 12 weeks

  2. 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.

    Measured: evaluation before treatment, immediately at the end of treatment and after 12 weeks

  3. change in Core Strenght

    The time spent in the Prone Bridge Test (in the prone position) will be evaluated in seconds.

    Measured: evaluation before treatment, immediately at the end of treatment and after 12 weeks

  4. 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.

    Measured: evaluation before treatment, immediately at the end of treatment and after 12 weeks

  5. 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

    Measured: evaluation before treatment, immediately at the end of treatment and after 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2022
  2. Study start1 Nov 2022
  3. Primary completion4 Apr 2023
  4. Study completion30 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05662579
Sponsor's protocol ID
Resistência do core no quadril
Acronym
GTPS
Status last verified
Apr 2023
First submitted
7 Mar 2022
Last updated
26 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Publications

  • Ekstrom RA, Donatelli RA, Carp KC. Electromyographic analysis of core trunk, hip, and thigh muscles during 9 rehabilitation exercises. J Orthop Sports Phys Ther. 2007 Dec;37(12):754-62. doi: 10.2519/jospt.2007.2471. Epub 2007 Aug 29.

    PubMed 18560185
  • Fearon AM, Scarvell JM, Neeman T, Cook JL, Cormick W, Smith PN. Greater trochanteric pain syndrome: defining the clinical syndrome. Br J Sports Med. 2013 Jul;47(10):649-53. doi: 10.1136/bjsports-2012-091565. Epub 2012 Sep 14.

    PubMed 22983121
  • 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.

    PubMed 15706550
  • Ganderton C, Semciw A, Cook J, Pizzari T. Demystifying the Clinical Diagnosis of Greater Trochanteric Pain Syndrome in Women. J Womens Health (Larchmt). 2017 Jun;26(6):633-643. doi: 10.1089/jwh.2016.5889. Epub 2017 Mar 6.

    PubMed 28263673
  • Mallow M, Nazarian LN. Greater trochanteric pain syndrome diagnosis and treatment. Phys Med Rehabil Clin N Am. 2014 May;25(2):279-89. doi: 10.1016/j.pmr.2014.01.009. Epub 2014 Mar 18.

    PubMed 24787333
  • 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.

    PubMed 26955229
  • 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.

    PubMed 21893483
  • 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.

    PubMed 19439758

Questions about this trial

What is this clinical trial studying?

A study testing Exercises in people with Trochanteric Bursitis, run by Universidade Estadual de Londrina at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Christiane Macedo, PhD (+5543991015123, chmacedo@uel.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

initial postural control (time frame: before starting treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05662579, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.

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