NCT05872971

Brief Summary

Introduction: Greater Trochanter Pain Syndrome (GTPS) includes a number of disorders involving the lateral hip region, including bursitis, gluteal lacerations, and trigger points in the contractile tissue crossing the hip. As an alternative resource for pain relief, dry needling, known as Dry Needling (DN) is a technique that has been shown to be effective in the treatment of soft tissue injuries and neuromyofascial pain, with positive effects on musculoskeletal conditions. Objective: to compare the administration of ND and laser therapy on the effectiveness of reducing lateral hip pain and improving function in women with GTPS. Materials and methods: The sample will consist of 30 women, aged between 35 and 60, randomized into 2 groups: GND group (n=15) and GLT group (n=15). Participants will complete the sample characterization questionnaire, the numerical pain scale and the VISA Tendinopathy Questionnaire for Greater Trochanteric Pain Syndrome (VISA-G). Subsequently, they will be submitted to evaluation through functional tests sit and stand 30 seconds, Timed up and go test. After the evaluation, they will be submitted to the treatment. The GDN will receive treatment using the technique by a physiotherapist with specific training in NP. The application will be through the deep technique, in the regions of trigger points of muscles of the posterolateral region of the hip with duration of application from 30 to 60 seconds per point, 8 points of application will be standardized, in the region of muscles of the posterolateral region. hip side. The GLT will receive the Laser application by a physiotherapist specialized in traumato-orthopedics. The equipment will be the Infrared Laser (wavelength 904 nm), by punctual technique. Eight application points will be standardized in the muscles region of the posterolateral region of the hip.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

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

Study Start

First participant enrolled

April 24, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2024

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

April 25, 2023

Last Update Submit

May 14, 2023

Conditions

Keywords

lateral hip paintrochanteric bursitisgreater trochanteric gluteal syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

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

Secondary Outcomes (3)

  • change in hip function

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

  • change in lower limb function

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

  • change in lower limb function

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

Study Arms (2)

Dry Needling

EXPERIMENTAL

The technique will be used by a physiotherapist experienced in orthopedic conditions and with specific training in DN.

Device: Dry Needling

Lasertherapy

ACTIVE COMPARATOR

The application of the Laser will be performed by a physiotherapist specialized in traumato-orthopedics.

Device: Lasertherapy

Interventions

Dry Needling: The technique will be used by a physiotherapist experienced in orthopedic conditions and with specific training in DN. The application will be through the deep technique, above 10mm deep, the therapist will score trigger points regions of the muscles of the posterolateral region of the hip with application duration of 30 to 60 seconds. Eight points of application will be standardized in the region of the muscles of the posterolateral region of the hip.

Dry Needling

Lasertherapy: The application of the Laser will be performed by a physiotherapist specialized in traumato-orthopedics. The equipment will be infrared laser (904 nm), by point technique. Eight points of application will be standardized in the region of muscles of the posterolateral region of the hip. The time, dose and amounts of application points will be guided according to the dosimetry criteria of the World Association for Photobiomodulation Therapy.

Lasertherapy

Eligibility Criteria

Age35 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Lateral hip pain (VAS 3) for at least 3 months
  • referring pain to palpation of the insertion of the tendon of the middle and maximum gluteus in the major trochanter
  • reproduction of symptoms in at least one of the following tests: 1 - FABER test (Flexion, abduction and external hip rotation) ; 2- Resistive External Rotation Test, 3 - Resistive Isometric Abduction Test , 4 - Unipodal Support Test for 30 seconds.

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 three months
  • participants who need to use anti-inflammatory drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiane Macedo

Londrina, ParanĂ¡, 86038-350, Brazil

RECRUITING

Related Publications (5)

  • Shbeeb MI, Matteson EL. Trochanteric bursitis (greater trochanter pain syndrome). Mayo Clin Proc. 1996 Jun;71(6):565-9. doi: 10.4065/71.6.565.

    PMID: 8642885BACKGROUND
  • 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
  • Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.

    PMID: 20823359BACKGROUND
  • Fearon AM, Ganderton C, Scarvell JM, Smith PN, Neeman T, Nash C, Cook JL. Development and validation of a VISA tendinopathy questionnaire for greater trochanteric pain syndrome, the VISA-G. Man Ther. 2015 Dec;20(6):805-13. doi: 10.1016/j.math.2015.03.009. Epub 2015 Apr 2.

    PMID: 25870117BACKGROUND
  • Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.

    PMID: 23680877BACKGROUND

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

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 and orthopedics. The intervention will consist of 6 weeks, 2 times a week, and the variables of interest will be measured in the pre-treatment period, after the first week, after the third week of treatment, after the end of treatment and after that, there will be a follow up of eight and twelve weeks after treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
advisor

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 24, 2023

Study Start

April 24, 2023

Primary Completion

July 3, 2024

Study Completion

December 3, 2024

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations