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

NCT06241872 | Completed

• 1 other identifier: KutahyaHSU-DRGOKPINAR-43
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Greater Trochanteric Pain Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pressure Pain Threshold Measurement

  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

  Time frame 1: Up to 24 hour before the first intervention, Time frame 2: One week after the last intervention.

• Hip ROM Measurement

  Time frame 1: Up to 24 hour before the first intervention, Time frame 2: One week after the last intervention.

Study Arms (2)

Dry needling group (study group)

EXPERIMENTAL

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

Sham dry needling group (control group)

SHAM COMPARATOR

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

Interventions

Dry needling group OTHER

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

Also known as: Study group

Dry needling group (study group); Sham dry needling group (control group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Kütahya, 43020, Turkey (Türkiye)

Location

Study Officials

• Hasan H Gökpınar, Ass. Prof.

  Kutahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: March 20, 2024
• Primary Completion: December 10, 2024
• Study Completion: February 15, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)