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Dry Needling and Lateral Hip Pain (GTPS)

Primary Purpose

Trochanteric Bursitis

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dry Needling
Lasertherapy
Sponsored by
Universidade Estadual de Londrina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trochanteric Bursitis focused on measuring lateral hip pain, trochanteric bursitis, greater trochanteric gluteal syndrome

Eligibility Criteria

35 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. 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 three months participants who need to use anti-inflammatory drugs

Sites / Locations

  • Christiane MacedoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry Needling

Lasertherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

change in hip function
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.
change in lower limb function
In each assessment, participants will perform the Timed Up And Go Test (TUG)
change in lower limb function
In each assessment, participants will perform the 30'' Sit To Stand Test.

Full Information

First Posted
April 25, 2023
Last Updated
May 14, 2023
Sponsor
Universidade Estadual de Londrina
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1. Study Identification

Unique Protocol Identification Number
NCT05872971
Brief Title
Dry Needling and Lateral Hip Pain (GTPS)
Official Title
Dry Needling vs Lasertherapy in Greater Trochanteric Pain Syndrome (GTPS): Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
July 3, 2024 (Anticipated)
Study Completion Date
December 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual de Londrina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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: VISA-G questionnaire Functional assessment: Soon after, the following functional tests will be performed: 30-second Sit to Stand Test (SL30) and the Timed Up and Go Test (TUG). 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), 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trochanteric Bursitis
Keywords
lateral hip pain, trochanteric bursitis, greater trochanteric gluteal syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling
Arm Type
Experimental
Arm Description
The technique will be used by a physiotherapist experienced in orthopedic conditions and with specific training in DN.
Arm Title
Lasertherapy
Arm Type
Active Comparator
Arm Description
The application of the Laser will be performed by a physiotherapist specialized in traumato-orthopedics.
Intervention Type
Device
Intervention Name(s)
Dry Needling
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Lasertherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in pain intensity
Description
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
Time Frame
evaluation before treatment, immediately at the end of treatment and 12 weeks post treatment
Secondary Outcome Measure Information:
Title
change in hip function
Description
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.
Time Frame
evaluation before treatment, immediately at the end of treatment and after 12 weeks post treatment
Title
change in lower limb function
Description
In each assessment, participants will perform the Timed Up And Go Test (TUG)
Time Frame
evaluation before treatment, immediately at the end of treatment and 12 weeks post treatment
Title
change in lower limb function
Description
In each assessment, participants will perform the 30'' Sit To Stand Test.
Time Frame
evaluation before treatment, immediately at the end of treatment and 12 weeks post treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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 three months participants who need to use anti-inflammatory drugs
Facility Information:
Facility Name
Christiane Macedo
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86038-350
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christiane Macedo
Phone
+5543991015123
Email
chmacedo@uel.br

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Citations:
PubMed Identifier
8642885
Citation
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.
Results Reference
background
PubMed Identifier
21893483
Citation
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.
Results Reference
background
PubMed Identifier
20823359
Citation
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.
Results Reference
background
PubMed Identifier
25870117
Citation
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.
Results Reference
background
PubMed Identifier
23680877
Citation
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.
Results Reference
background

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Dry Needling and Lateral Hip Pain (GTPS)

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