Evaluation of the Effectiveness of Dry Needling Treatment in Patients Diagnosed With Greater Trochanteric Pain Syndrome

Greater Trochanteric Pain Syndrome Clinical Trial

Official title:

Evaluation of the Effectiveness of Dry Needling Treatment in Patients Diagnosed With Greater Trochanteric Pain Syndrome Accompanied by Myofascial Pain Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241872
• Other study ID #: KutahyaHSU-DRGOKPINAR-43
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: May 15, 2024

Study information

• Verified date: March 2024
• Source: Kutahya Health Sciences University
• Contact: Hasan H Gökpinar, Ass. Prof.
• Phone: +905052842222
• Email: hasanhuseyin.gokpinar[@]ksbu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Greater Trochanteric Pain Syndrome (GTPS) is characterized by lateral hip pain, pain radiating to the lateral leg, tenderness and rotation around the greater trochanter, and pain with specific activities such as abduction or adduction. GTPS is primarily diagnosed clinically. Conservative treatment for GTPS includes activity modification, physiotherapy, nonsteroidal anti-inflammatory drugs, local corticosteroids, and platelet-rich plasma injections. Particularly, regional muscle sensitivity, such as in the gluteus maximus, is prominent. In recent years, dry needling therapy, which has gained popularity and increased research attention, has become an alternative treatment option, especially if the underlying cause is myofascial pain syndrome or deeper issues like piriformis syndrome.

The provided text discusses dry needling as a treatment for various neuromusculoskeletal pain conditions, emphasizing its use as a minimally invasive procedure that involves applying filiform needles to the relevant muscle tissue without the administration of pharmacological drugs. The literature suggests that dry needling therapy has the ability to induce biochemical, biomechanical, endocrinological, and neurovascular changes associated with the reduction of pain and disability in individuals. However, the optimal treatment dosage has not yet been determined, and there is inconsistency in the literature regarding the number of needles to be inserted and the duration of needle retention.

Studies evaluating the effectiveness of dry needling are often designed to compare or add it to other injection therapies. Additionally, there is a limited number of studies conducted with real-time imaging. In the planned study, the use of ultrasound-guided dry needling aims to provide a sham application opportunity, where the patient is blinded to the nature of the procedure, allowing for a meaningful investigation of efficacy. This aspect of the study is expected to contribute significantly to the literature.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: May 15, 2024
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Age between 18 and 80 years old. Ability to read and write. Clinically diagnosed with greater trochanteric pain syndrome. Pain Visual Analog Scale (VAS) score of 6 or higher.

Exclusion Criteria:

History of previous lumbar and hip surgery. Lesions, atrophy, or scars in the skin around the hip area. Received physiotherapy for the hip, lumbar, or lower extremities in the last 6 months.

Underwent an interventional procedure for the hip or lumbar region for the same reason in the last 3 months.

Used steroids in the last 1 month. Special conditions such as epilepsy, pregnancy, injection phobia, etc. Inability to comply with the restriction on the use of both steroid and non-steroidal anti-inflammatory drugs during the treatment period.

Subcutaneous fat tissue thickness in the hip area being 5 cm or more.

Related Conditions & MeSH terms

• Bursitis
• Greater Trochanteric Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Other:
• Dry needling group
Dry needling will be performed using a 27-gauge, 5 cm long dental needle, guided by ultrasound, on predetermined trigger points in patients.

Locations

Country	Name	City	State
Turkey	Kutahya Health Sciences University	Kutahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	"Visual Analog Scale (VAS)" is a measurement instrument often used in healthcare to assess the intensity or characteristics of subjective experiences such as pain. It typically consists of a straight line, usually 10 centimeters in length, with endpoints representing extremes (e.g., "no pain" to "worst imaginable pain"). Patients mark on the line to indicate their subjective experience, and the distance from one endpoint provides a numerical score representing the intensity of the sensation being measured. The VAS is commonly employed in pain assessment but can also be adapted for various other subjective evaluations.	Time frame 1: Up to 24 hour before the first intervention, Time frame 2: Up to 24 hour before the second intervention, Time frame 3: Up to 24 hour before the third intervention, Time frame 4: One week (and one month) after the last intervention.
Primary	Patient-Specific Functional Scale	"Patient-Specific Functional Scale" (PSFS). The PSFS is a self-report outcome measure commonly used in healthcare, particularly in physical therapy and rehabilitation settings. It is designed to assess the patient's perceived difficulty in performing specific activities that are relevant to their daily life and function. Identification of Activities: The patient is asked to identify and list three to five activities that they find challenging or have difficulty performing due to their condition or symptoms.; Rating Scale: For each identified activity, the patient is asked to rate their current level of difficulty on a numerical scale, often ranging from 0 to 10. A score of 0 indicates no difficulty, while 10 indicates the maximum difficulty.; Follow-up Assessments: The same activities and rating scale are used in follow-up assessments to track changes over time or in response to interventions.	Time frame 1: Up to 24 hour before the first intervention, Time frame 2: Up to 24 hour before the second intervention, Time frame 3: Up to 24 hour before the third intervention, Time frame 4: One week (and one month) after the last intervention.
Secondary	Pressure Pain Threshold Measurement	"Pressure Pain Threshold Measurement" refers to the assessment of the amount of pressure applied to a specific point on the body before the individual perceives it as painful. This measurement is commonly used in clinical settings to evaluate pain sensitivity and threshold. The process involves gradually applying pressure to a specific area until the individual signals that they begin to feel pain. It is a quantitative way to assess pain perception and is often utilized in research, physical therapy, and other healthcare disciplines to understand pain levels and responses.	Time frame 1: Up to 24 hour before the first intervention, Time frame 2: Up to 24 hour before the second intervention, Time frame 3: Up to 24 hour before the third intervention, Time frame 4: One week (and one month) after the last intervention.
Secondary	The Oswestry Disability Index	Oswestry Disability Index (ODI) specifically designed to assess the impact of low back pain on a person's daily activities and functioning. The Oswestry Disability Index is a widely used self-report questionnaire that helps quantify the degree of disability experienced by individuals with low back pain.The ODI typically consists of ten sections, each addressing a different aspect of daily life and function. The sections cover topics such as pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment or other daily activities. For each section, individuals rate their level of disability, and the overall score is calculated as a percentage of the maximum possible disability.	Time frame 1: Up to 24 hour before the first intervention, Time frame 2: One week after the last intervention.
Secondary	Hip ROM Measurement	Range of motion (ROM) in the hip joint is a crucial aspect of musculoskeletal function, and measuring it can provide valuable information about joint health, flexibility, and potential issues related to the hip.; Hip ROM measurements typically involve assessing the movement capabilities of the hip joint in different directions, including flexion, extension, abduction, adduction, internal rotation, and external rotation	Time frame 1: Up to 24 hour before the first intervention, Time frame 2: One week after the last intervention.