NCT05662579

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

March 7, 2022

Last Update Submit

April 25, 2023

Conditions

Keywords

lateral hip paintrochanteric bursitisgluteus medius tendinosisgreater trochanteric gluteal syndrome

Outcome Measures

Primary Outcomes (6)

  • initial postural control

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

    before starting treatment

  • Postural control after treatment

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

    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.

    12 weeks after the end of treatment

  • initial Muscle Ativation

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

    before starting treatment

  • Muscle Ativation after treatment

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

    immediately after the end of treatment

  • Muscle Ativation after 12 weeks

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

    12 weeks after the end of treatment

Secondary Outcomes (5)

  • change in hip function

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

  • change in severity of Symptoms

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

  • change in Core Strenght

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

  • change in Muscle Strenght

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

  • change in pain intensity

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

Study Arms (2)

hip exercises

EXPERIMENTAL

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

hip + core exercises

EXPERIMENTAL

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

Interventions

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 exerciseship exercises

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of Londrina

Londrina, ParanĂ¡, 86041-263, Brazil

RECRUITING

Related Publications (8)

  • 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.

    PMID: 18560185BACKGROUND
  • 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.

    PMID: 22983121BACKGROUND
  • 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.

    PMID: 15706550BACKGROUND
  • 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.

    PMID: 28263673BACKGROUND
  • 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.

    PMID: 24787333BACKGROUND
  • 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.

    PMID: 26955229BACKGROUND
  • 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.

    PMID: 21893483BACKGROUND
  • 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.

    PMID: 19439758BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Christiane Macedo, PhD

CONTACT

Christiane Macedo

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The evaluations of the participants and the analysis of the data will be carried out by a researcher blind to the allocation of the subjects in each group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2022

First Posted

December 22, 2022

Study Start

November 1, 2022

Primary Completion

April 4, 2023

Study Completion

July 30, 2023

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations