Greater Trochanteric Pain SyndromeNCT06241872
Evaluation of the Effectiveness of Dry Needling Treatment in Patients Diagnosed with Greater Trochanteric Pain Syndrome
A study testing Dry needling group in people with Greater Trochanteric Pain Syndrome, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Greater Trochanteric Pain Syndrome
- What is being tested?
- Dry needling group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2024to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, Kütahya, 43020
About this study
Official title: 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.
- Conditions
- Greater Trochanteric Pain Syndrome
- Being tested
- Dry needling group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needling groupOther
Also called Study group
Dry needling will be performed using a 27-gauge, 5 cm long dental needle, guided by ultrasound, on predetermined trigger points in patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Dry needling group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
"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.
Measured: 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.
Measured: 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
Measured: Time frame 1: Up to 24 hour before the first intervention, Time frame 2: One week after the last intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start20 Mar 2024
- Primary completion10 Dec 2024
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Greater Trochanteric Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Hüseyin Gökpınar, Kutahya Health Sciences University
- Investigators
- Hasan H Gökpınar, Ass. Prof., Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241872
- Sponsor's protocol ID
- KutahyaHSU-DRGOKPINAR-43
- Status last verified
- Mar 2025
- First submitted
- 28 Jan 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Dry Needling Treatment in Patients Diagnosed with Greater Trochanteric Pain Syndrome Accompanied by Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT06241872
- Acronym / sponsor ID
- KutahyaHSU-DRGOKPINAR-43
- Conditions
- Greater Trochanteric Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling group (study group) | Experimental | Other: Dry needling groupFor 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. |
| Sham dry needling group (control group) | Sham comparator | Other: Dry needling groupFor 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry needling groupAlso: Study groupDry needling will be performed using a 27-gauge, 5 cm long dental needle, guided by ultrasound, on predetermined trigger points in patients. | Other | Dry needling group (study group), Sham dry needling group (control group) |
Primary outcome
Visual Analog Scale
Time frame: 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.
"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.
Patient-Specific Functional Scale
Time frame: 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" (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.
3 secondary outcomes
Pressure Pain Threshold Measurement
Time frame: 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: 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: Time frame 1: Up to 24 hour before the first intervention, Time frame 2: One week after the last intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hasan H Gökpınar, Ass. Prof. principal investigator
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling group in people with Greater Trochanteric Pain Syndrome, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.