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

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

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.

Study Overview

• Status: Completed
• Conditions: Greater Trochanteric Pain Syndrome
• Intervention / Treatment: Other: Dry needling group

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kutahya, Turkey, 43020
    • Kutahya Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry needling group (study group); For patients in this group, dry needling will be performed once a week for three weeks on trigger points described as pain points in the Copeman nodule, gluteus medius, gluteus maximus, and iliotibial band muscles, guided by ultrasound. Patients will be instructed to perform daily stretching exercises outlined in the home program and mark their daily use of paracetamol on the provided schedule if needed. They will refrain from using NSAIDs or steroids during this period.	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.; Other Names: Study group
Sham Comparator: Sham dry needling group (control group); For the patients in this group, dry needling will be performed once a week for three weeks on trigger points described as pain points in the Copeman nodule, gluteus medius, gluteus maximus, and iliotibial band muscles, guided by ultrasound. However, the needles will not penetrate beyond the subcutaneous fatty tissue. Patients will be instructed to perform daily stretching exercises outlined in the home program and mark their daily use of paracetamol on the provided schedule if needed. They will refrain from using NSAIDs or steroids during this period.	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.; Other Names: Study group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Principal Investigator: Hasan H Gökpınar, Ass. Prof., Kutahya Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Actual): December 10, 2024
• Study Completion (Actual): February 15, 2025

Study Registration Dates

• First Submitted: January 28, 2024
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 8, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mental Disorders; Pathologic Processes; Joint Diseases; Disease; Somatoform Disorders; Syndrome; Bursitis
• Other Study ID Numbers: KutahyaHSU-DRGOKPINAR-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No