Piriformis Muscle SyndromeNCT06095180
Comparison of Ultrasound-guided Steroid Injection and Dry Needling in Piriformis Muscle Syndrome
A study testing corticosteroid injection, dry needling and exercise in people with Piriformis Muscle Syndrome, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital.
Trial summary
The aim of this study is to to compare its effectiveness ultrasound-guided steroid injection, dry needling treatments and exercises in patients diagnosed with piriformis syndrome. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Piriformis Muscle Syndrome
- What is being tested?
- corticosteroid injection, dry needling and exercise
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2023to 26 Aug 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-60,
- Hip pain for ≥1 month
- Local piriformis pain with prolonged sitting (>20 minutes) and increased sensitivity
- Patients with suspected piriformis syndrome based on clinical maneuvers
- Signing and informed consent from showing consent to participate in the study
Who cannot join
- Hip surgery
- Lumbar disc disease
- History of inflammatory hip disease
- Medical treatment for pain is started
- Neurological deficit
- Breastfeeding or pregnant
Show all 13Show fewer
- Allergy to local anesthetic
- Use of anticoagulants
- Body mass index >35
- Active psychiatric illness
- Uncontrolled hypertension and diabetes mellitus disease
- Noncompensated chronic lung/heart/renal failure
- History of vascular/tumoral disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Efficacy of Ultrasound-Guided Steroid Injection and Dry Needling in Piriformis Muscle Syndrome
The aim of this study is to to compare its effectiveness ultrasound-guided steroid injection, dry needling treatments and exercises in patients diagnosed with piriformis syndrome.
Read the detailed description
Piriformis syndrome is a painful entrapment neuropathy caused by compression of the sciatic nerve under the piriformis muscle. The most common cause is myofascial pain syndrome. There is no gold standard treatment for piriformis syndrome. The main purpose of treatment methods is to reduce local pain, muscle tension and spasm. This work; it will contribute to the literature by comparing steroid, dry needling and exercise treatments in patients with piriformis syndrome.
- Conditions
- Piriformis Muscle Syndrome
- Being tested
- corticosteroid injection, dry needling, exercise
- Keywords
- piriformis syndrome, steroid injection, dry needling, exercise
- Medical subject headings
- Piriformis Muscle Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corticosteroid injectionOther
In the steroid group, 4 mL lidocaine 2% + 1 mL betamethasone injection will be administered under ultrasound guidance and conventional treatment will be given (conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition)
dry needlingOther
In the dry needling group, a total of 3 sessions of dry needling will be performed once a week using a 0.60×100 mm sterile needle under ultrasound guidance and conventional treatment will be given ((conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition)
exerciseOther
The conventional treatment group (control group) will be given piriformis stretching exercises including hip and knee flexion, hip abduction and external rotation in the supine position. It will be stated that patients should do 2 sets a day and each set should be 10 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| corticosteroid group | Active comparator | In the steroid group, 4 mL lidocaine 2% + 1 mL betamethasone injection will be administered under ultrasound guidance and conventional treatment will be given (conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition) Receives: Other: corticosteroid injection |
| dry needling group | Active comparator | In the dry needling group, a total of 3 sessions of dry needling will be performed once a week using a 0.60×100 mm sterile needle under ultrasound guidance and conventional treatment will be given ((conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition) Receives: Other: dry needling |
| control group | Other | The conventional treatment group (control group) will be given piriformis stretching exercises including hip and knee flexion, hip abduction and external rotation in the supine position. It will be stated that patients should do 2 sets a day and each set should be 10 repetitions. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) (Sitting)
Average hip pain intensity in a sitting position over the past 24 hours, a visual analog scale. (VAS; ranging from 0 to 10, 0 = no pain and 10 = worst possible pain)
Measured: at baseline and change from baseline VAS (sitting) at 4 weeks and 12 weeks
Visual Analog Scale (VAS) (Resting)
Average hip pain intensity at rest over the past week is a visual analog scale. (VAS; ranging from 0 to 10, 0 = no pain and 10 = worst possible pain)
Measured: at baseline and change from baseline VAS (resting) at 4 weeks and 12 weeks
Visual Analog Scale (VAS) (Movement)
Average hip pain intensity during movement over the past 1 week is a visual analog scale. (VAS; ranging from 0 to 10, 0 = no pain and 10 = worst possible pain)
Measured: at baseline and change from baseline VAS (movement) at 4 weeks and 12 weeks
Secondary outcomes (1)
Oswestry disability index (ODI)
ODI includes questions regarding pain severity, sexual function, sleep quality and personal care, ability to work, sit, walk, lift, stand and travel. Total score ranges from 0-50, with higher scores indicating more injury.
Measured: at baseline and change from baseline ODI at 4 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start28 Nov 2023 (estimated)
- Primary completion26 Aug 2024 (estimated)
- Study completion26 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Piriformis Muscle SyndromeStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Ayşenur Şimşek Yağlıoğlu, MD, Principal investigator, Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095180
- Sponsor's protocol ID
- 41
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Ultrasound-Guided Steroid Injection and Dry Needling in Piriformis Muscle Syndrome
- ClinicalTrials.gov ID
- NCT06095180
- Acronym / sponsor ID
- 41
- Conditions
- Piriformis Muscle Syndrome
- Keywords
- piriformis syndrome, steroid injection, dry needling, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 28 Nov 2023 (estimated)
- Primary completion
- 26 Aug 2024 (estimated)
- Study completion
- 26 Aug 2024 (estimated)
- First posted
- 23 Oct 2023 (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.
The aim of this study is to to compare its effectiveness ultrasound-guided steroid injection, dry needling treatments and exercises in patients diagnosed with piriformis syndrome.
Detailed description
Piriformis syndrome is a painful entrapment neuropathy caused by compression of the sciatic nerve under the piriformis muscle. The most common cause is myofascial pain syndrome. There is no gold standard treatment for piriformis syndrome. The main purpose of treatment methods is to reduce local pain, muscle tension and spasm. This work; it will contribute to the literature by comparing steroid, dry needling and exercise treatments in patients with piriformis syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| corticosteroid group | Active comparator | Other: corticosteroid injectionIn the steroid group, 4 mL lidocaine 2% + 1 mL betamethasone injection will be administered under ultrasound guidance and conventional treatment will be given (conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition) |
| dry needling group | Active comparator | Other: dry needlingIn the dry needling group, a total of 3 sessions of dry needling will be performed once a week using a 0.60×100 mm sterile needle under ultrasound guidance and conventional treatment will be given ((conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition) |
| control group | Other | Other: exerciseThe conventional treatment group (control group) will be given piriformis stretching exercises including hip and knee flexion, hip abduction and external rotation in the supine position. It will be stated that patients should do 2 sets a day and each set should be 10 repetitions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18-60,
- Hip pain for ≥1 month
- Local piriformis pain with prolonged sitting (>20 minutes) and increased sensitivity
- Patients with suspected piriformis syndrome based on clinical maneuvers
- Signing and informed consent from showing consent to participate in the study
Key exclusion criteria (13 listed)
- Hip surgery
- Lumbar disc disease
- History of inflammatory hip disease
- Medical treatment for pain is started
- Neurological deficit
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 |
|---|---|---|
| corticosteroid injectionIn the steroid group, 4 mL lidocaine 2% + 1 mL betamethasone injection will be administered under ultrasound guidance and conventional treatment will be given (conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition) | Other | corticosteroid group |
| dry needlingIn the dry needling group, a total of 3 sessions of dry needling will be performed once a week using a 0.60×100 mm sterile needle under ultrasound guidance and conventional treatment will be given ((conventional treatment includes piriformis stretching exercises. It will be stated that patients should do 2 sets a day and each set should be 10 repetition) | Other | dry needling group |
| exerciseThe conventional treatment group (control group) will be given piriformis stretching exercises including hip and knee flexion, hip abduction and external rotation in the supine position. It will be stated that patients should do 2 sets a day and each set should be 10 repetitions. | Other | control group |
Primary outcome
Visual Analogue Scale (VAS) (Sitting)
Time frame: at baseline and change from baseline VAS (sitting) at 4 weeks and 12 weeks
Average hip pain intensity in a sitting position over the past 24 hours, a visual analog scale. (VAS; ranging from 0 to 10, 0 = no pain and 10 = worst possible pain)
Visual Analog Scale (VAS) (Resting)
Time frame: at baseline and change from baseline VAS (resting) at 4 weeks and 12 weeks
Average hip pain intensity at rest over the past week is a visual analog scale. (VAS; ranging from 0 to 10, 0 = no pain and 10 = worst possible pain)
Visual Analog Scale (VAS) (Movement)
Time frame: at baseline and change from baseline VAS (movement) at 4 weeks and 12 weeks
Average hip pain intensity during movement over the past 1 week is a visual analog scale. (VAS; ranging from 0 to 10, 0 = no pain and 10 = worst possible pain)
1 secondary outcome
Oswestry disability index (ODI)
Time frame: at baseline and change from baseline ODI at 4 weeks and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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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.
Ayşenur Şimşek Yağlıoğlu, MD principal investigator
Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing corticosteroid injection, dry needling and exercise in people with Piriformis Muscle Syndrome, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital.
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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayşenur Şimşek Yağlıoğlu, MD (+903122912444, aysenursimsek33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (Sitting) (time frame: at baseline and change from baseline VAS (sitting) at 4 weeks and 12 weeks). The study lists 3 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 23 Oct 2023.