Dry Needling and Lateral Hip Pain (GTPS)

Trochanteric Bursitis Clinical Trial

Official title:

Dry Needling vs Lasertherapy in Greater Trochanteric Pain Syndrome (GTPS): Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05872971
• Other study ID #: Dry Needling e quadril
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2023
• Est. completion date: December 3, 2024

Study information

• Verified date: May 2023
• Source: Universidade Estadual de Londrina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 3, 2024
• Est. primary completion date: July 3, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bursitis
• Trochanteric Bursitis

Intervention

Device:
• Dry Needling
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.
• Lasertherapy
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.

Locations

Country	Name	City	State
Brazil	Christiane Macedo	Londrina	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual de Londrina

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	evaluation before treatment, immediately at the end of treatment and after 12 weeks post treatment
Secondary	change in lower limb function	In each assessment, participants will perform the Timed Up And Go Test (TUG)	evaluation before treatment, immediately at the end of treatment and 12 weeks post treatment
Secondary	change in lower limb function	In each assessment, participants will perform the 30'' Sit To Stand Test.	evaluation before treatment, immediately at the end of treatment and 12 weeks post treatment