Clinical trial NCT05872971: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Trochanteric Bursitis
Keywords: lateral hip pain
trochanteric bursitis
greater trochanteric gluteal syndrome
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in pain intensity
timeFrame: evaluation before treatment, immediately at the end of treatment and 12 weeks post treatment
Secondary outcomes:
measure: change in hip function
timeFrame: evaluation before treatment, immediately at the end of treatment and after 12 weeks post treatment
measure: change in lower limb function
timeFrame: evaluation before treatment, immediately at the end of treatment and 12 weeks post treatment
measure: change in lower limb function
timeFrame: evaluation before treatment, immediately at the end of treatment and 12 weeks post treatment
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Christiane Macedo
state: Paraná
Study officials:
References:
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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.
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.
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