Piriformis Muscle SyndromeNCT05962515
Efficacy of Ultrasound-Guided Dry Needling Therapy and Exercise in Piriformis Muscle Syndrome
An observational study of Piriformis Muscle Syndrome and Dry Needling, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Piriformis muscle syndrome (PMS) is a neuromuscular disorder that can cause symptoms of hip joint motion limitation, buttock pain and tenderness, and numbness radiating to the back of the thigh due to compression or irritation of the sciatic nerve.In the etiology of PMS myofascial trigger points are the most common… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Piriformis Muscle Syndrome, Dry Needling, Ultrasonography
- What is being tested?
- ultrasound guided dry needling
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2022to 1 Jul 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients were divided into two groups as those who will accept DN treatment (Group 1 -n: 22) and those who will have physical exercise treatment (Group 2- n: 22). All patients in group 1 will have DN treatment to the piriformis muscle once a week for a total of 3 times under US guidance.
Who may be able to join
- Patients with isolated Piriformis Muscle Syndrome
- The diagnosis is based on patient's history and physical examination, bearing positive FAIR (flexion, adduction, internal rotation) test and/or tenderness or trigger point at the priformis muscle area and/or revealing the pain with maneuvers; such as Freiberg's maneuver (forceful internal rotation of the extended thigh in the supine position), Beatty's maneuver (actively abducting the affected thigh in the lateral decubitus position) and Pace's maneuver (resisted abduction of both thighs in the seated position).
Who cannot join
- Patients with comorbidities that prevented interventional treatment (e.g., inflammatory diseases, uncontrolled diabetes mellitus, uncontrolled hypertension, malignancy, pregnancy, and severe psychiatric disorders),
- Patients with other diagnoses that may cause hip and leg pain (e.g.,lumbar disc herniation, sciatic nerve injury history, sacroiliac and hip joint pathologies)
- Aged under 18 years old
- Patients who will not accept interventional or physical therapy modalities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tepecik Training and Research Hospital
Izmir, 35000
About this study
Official title: Evaluation of the Efficacy of Ultrasound-Guided Dry Needling Therapy and Exercise Programme in Piriformis Muscle Syndrome
Piriformis muscle syndrome (PMS) is a neuromuscular disorder that can cause symptoms of hip joint motion limitation, buttock pain and tenderness, and numbness radiating to the back of the thigh due to compression or irritation of the sciatic nerve.In the etiology of PMS myofascial trigger points are the most common cause and also hypertrophy in the piriformis muscle tissue, inflammation, trauma, anatomical variations of the piriformis muscle or sciatic nerve may also cause the development of PMS . Physical examination supports the diagnosis of PMS and may help to eliminating competing diagnoses. Multiple physical examination maneuvers have been identified to help diagnose but no physical examination maneuver is diagnostic for PMS. Compression and deep palpation may also exacerbate buttock or gluteal pain. Electrodiagnostic tests are usually normal in FMS and useful in excluding other conditions such as lumbosacral radiculopathy .There is no gold standard treatment option for PMS, conservative treatment and lifestyle changes remain the mainstays for the treatment. Piriformis muscle stretching is the form of an exercise technique in physiotherapy method that is generally used for those patients. The exercises focused on relaxing the priformis muscle to increase the resting length of the muscle and reduce the potential sciatic nerve compression because of this thigtness. Dry needling (DN) therapy is a treatment method where myofascial trigger points are stimulated using acupuncture needles or injection needles .DN can be applied according to the anatomical landmark method or under the guidance of ultrasound (US) and fluoroscopic imaging. US guidance is important in the management of PMS, which allows imaging of specific deep muscle groups and avoids complications such as procedural pain and damage of neurovascular structures . There are no randomized controlled studies other than case series on the use and frequency of application of the US-guided DN technique in PMS. The aim of this study is to compare the effectiveness of dry needling treatment applied to the piriformis muscle once a week for a total of 3 times under US guidance and 3-week exercise program treatment in PMS. The secondary outcomes of this study is to evaluate and compare the effect of these treatment modalities on Visuel Analg Scale (VAS) scores ,Oswestry Disability Index (ODI), lower extremity functional scale (LEFS) and (Douleur Neuropathique 4 Questionare ) DN4 scores in PMS patients at 3 months follow up.
Read the detailed description
In this observational study, between January 2022 and April 2023, after excluding other hip, lumbar, sacroiliac region and lower extremity pain etiology diagnoses, 44 patients aged 18-70 years who are clinically diagnosed with PMS are planned to be included in the study. The diagnosis is based on patient's history and physical examination, bearing positive FAIR test and/or tenderness or trigger point at the priformis muscle area and/or revealing the pain with maneuvers; such as Freiberg's maneuver , Beatty's maneuver and Pace's maneuver . The demographic data (age, sex, occupation, body mass index scores), the side of the pain will be noted. Each patient in the study will receive and sign an informed consent form.The patients will divide into two groups ; group 1 (n:22)will have DN treatment to the piriformis muscle once a week for a total of 3 times under US guidance, all patients in group 2 (n:22) will have exercise programme for 3 weeks. Overall pain severity will measure by using visual analogue scale (VAS). Pain disability will assess with the Oswestry Disability Index (ODI) questionnaire, Physical function will rate with Lower Extremity Functional Scale (LEFS). Presence and severity of neuropathic pain will evaluate according to Douleur Neuropathique 4 questionnare (DN4). To identify the outcomes of the treatment modalities, pre-treatment, post-treatment 1st month and 3th-month scores will be used. Patients with comorbidities that prevented interventional treatment (e.g., inflammatory diseases, uncontrolled diabetes mellitus, uncontrolled hypertension, malignancy, pregnancy, and severe psychiatric disorders), patients with other diagnoses that may cause hip and leg pain (e.g.,lumbar disc herniation, sciatic nerve injury history, sacroiliac and hip joint pathologies) those aged under 18 years old and patients who did not accept interventional or physical therapy modalities are going to exclude from the study.
- Conditions
- Piriformis Muscle Syndrome, Dry Needling, Ultrasonography, Ultrasound Guided Dry Needling, Exercise Treatment
- Being tested
- ultrasound guided dry needling
- Keywords
- piriformis muscle syndrome, pain, dry needling, exercise, ultrasound, neuralgia, interventional ultrasonography, physical therapy modalities
- Medical subject headings
- Piriformis Muscle Syndrome, Pain, Motor Activity, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided dry needlingProcedure or surgery
Also called exercise programme
Dry needling was applied in the intervention room with sterile conditions the patient in the prone position.The low frequency (2-5 MHz) transducer is placed in the gluteal region in a slightly oblique position and sonographic scanning is started. First, the large mountain shadow of the iliac crest and gluteus maximus muscle is sonographically visualized in the midline. Then the transducer is shifted inferiorly until the sciatic notch is visualized. When the sciatic notch, sciatic nerve and the pear-shaped piriformis muscle above it are visualized, the patient's knee is flexed and the leg is rotated internally and externally, and the typical sliding motion of the piriformis muscle is observed. After the target point is determined, a 22 G spinal needle is applied from lateral to medial or from medial to lateral with in plane technique. The needle is inserted and withdrawn several times until the switch response in the piriformis muscle is observed and extinguished
| Study group | Role | What they receive |
|---|---|---|
| 1 | All patients in group 1 (n:22) had DN treatment applied to the piriformis muscle once a week for a total of 3 times under US guidance. Receives: Procedure: ultrasound guided dry needling | |
| 2 | All patients in group 2(n:22) had exercise programme for 3 weeks. Receives: Procedure: ultrasound guided dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visuel Analogue Scale
Overall pain severity was measured by using a 0 to 100 mm scale visual analogue scale (VAS).
Measured: change from baseline VAS scores at 3 months
Secondary outcomes (3)
Oswestry Disability Index (ODI) questionnaire,
Oswestry Disability Index (ODI) questionnaire, which measures pain disability consists of ten questions, each with six options . The questions include the pain intensity, ability to work, perform self care, sit ,stand, travel, lift, sleep pattern, socializing and sexual life. Every question was scored between 0 and 5 points. The highest score is 50 if all questions were answered, and indicates severe disability for the participant.
Measured: change from baseline ODI scores at 3 months
lower extremity functional scale (LEFS)
The LEFS consists of 20 items to rate the ability of functional status in performing different physical activities due to musculoskeletal problems affecting the lower extremities. Each question has five point scale, from 0 to 4 (0: unable to do the activity, 1: quite, 2: moderate, 3: somewhat, 4: no difficulty). The total score ranges from 0 to 80, with higher scores indicate better functional status
Measured: change from baseline LEFS scores at 3 months
Douleur Neuropathique 4 questionnare (DN4)
The questionnaire derived from this list, called DN4, included a series of four questions consisting of both sensory descriptors and signs related to bedside sensory examination. This provisional questionnaire was not intended to be exhaustive and was deliberately restricted to a minimum of simple and presumably discriminant items requiring yes or no responses.
Measured: change from baseline DN4 scores at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start20 Jan 2022
- Primary completion1 Apr 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, derya guner, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962515
- Sponsor's protocol ID
- 2022/2/1
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tabatabaiee A, Takamjani IE, Sarrafzadeh J, Salehi R, Ahmadi M. Ultrasound-guided dry needling decreases pain in patients with piriformis syndrome. Muscle Nerve. 2019 Nov;60(5):558-565. doi: 10.1002/mus.26671. Epub 2019 Aug 27.
PubMed 31415092Fusco P, Di Carlo S, Scimia P, Degan G, Petrucci E, Marinangeli F. Ultrasound-guided Dry Needling Treatment of Myofascial Trigger Points for Piriformis Syndrome Management: A Case Series. J Chiropr Med. 2018 Sep;17(3):198-200. doi: 10.1016/j.jcm.2018.04.002. Epub 2018 Aug 26.
PubMed 30228811Misirlioglu TO, Akgun K, Palamar D, Erden MG, Erbilir T. Piriformis syndrome: comparison of the effectiveness of local anesthetic and corticosteroid injections: a double-blinded, randomized controlled study. Pain Physician. 2015 Mar-Apr;18(2):163-71.
PubMed 25794202
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Ultrasound-Guided Dry Needling Therapy and Exercise Programme in Piriformis Muscle Syndrome
- ClinicalTrials.gov ID
- NCT05962515
- Acronym / sponsor ID
- 2022/2/1
- Conditions
- Piriformis Muscle Syndrome, Dry Needling, Ultrasonography, Ultrasound Guided Dry Needling, Exercise Treatment
- Keywords
- piriformis muscle syndrome, pain, dry needling, exercise, ultrasound, neuralgia, interventional ultrasonography, physical therapy modalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 27 Jul 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.
Piriformis muscle syndrome (PMS) is a neuromuscular disorder that can cause symptoms of hip joint motion limitation, buttock pain and tenderness, and numbness radiating to the back of the thigh due to compression or irritation of the sciatic nerve.In the etiology of PMS myofascial trigger points are the most common cause and also hypertrophy in the piriformis muscle tissue, inflammation, trauma, anatomical variations of the piriformis muscle or sciatic nerve may also cause the development of PMS . Physical examination supports the diagnosis of PMS and may help to eliminating competing diagnoses. Multiple physical examination maneuvers have been identified to help diagnose but no physical examination maneuver is diagnostic for PMS. Compression and deep palpation may also exacerbate buttock or gluteal pain. Electrodiagnostic tests are usually normal in FMS and useful in excluding other conditions such as lumbosacral radiculopathy .There is no gold standard treatment option for PMS, conservative treatment and lifestyle changes remain the mainstays for the treatment. Piriformis muscle stretching is the form of an exercise technique in physiotherapy method that is generally used for those patients. The exercises focused on relaxing the priformis muscle to increase the resting length of the muscle and reduce the potential sciatic nerve compression because of this thigtness. Dry needling (DN) therapy is a treatment method where myofascial trigger points are stimulated using acupuncture needles or injection needles .DN can be applied according to the anatomical landmark method or under the guidance of ultrasound (US) and fluoroscopic imaging. US guidance is important in the management of PMS, which allows imaging of specific deep muscle groups and avoids complications such as procedural pain and damage of neurovascular structures . There are no randomized controlled studies other than case series on the use and frequency of application of the US-guided DN technique in PMS. The aim of this study is to compare the effectiveness of dry needling treatment applied to the piriformis muscle once a week for a total of 3 times under US guidance and 3-week exercise program treatment in PMS. The secondary outcomes of this study is to evaluate and compare the effect of these treatment modalities on Visuel Analg Scale (VAS) scores ,Oswestry Disability Index (ODI), lower extremity functional scale (LEFS) and (Douleur Neuropathique 4 Questionare ) DN4 scores in PMS patients at 3 months follow up.
Detailed description
In this observational study, between January 2022 and April 2023, after excluding other hip, lumbar, sacroiliac region and lower extremity pain etiology diagnoses, 44 patients aged 18-70 years who are clinically diagnosed with PMS are planned to be included in the study. The diagnosis is based on patient's history and physical examination, bearing positive FAIR test and/or tenderness or trigger point at the priformis muscle area and/or revealing the pain with maneuvers; such as Freiberg's maneuver , Beatty's maneuver and Pace's maneuver . The demographic data (age, sex, occupation, body mass index scores), the side of the pain will be noted. Each patient in the study will receive and sign an informed consent form.The patients will divide into two groups ; group 1 (n:22)will have DN treatment to the piriformis muscle once a week for a total of 3 times under US guidance, all patients in group 2 (n:22) will have exercise programme for 3 weeks. Overall pain severity will measure by using visual analogue scale (VAS). Pain disability will assess with the Oswestry Disability Index (ODI) questionnaire, Physical function will rate with Lower Extremity Functional Scale (LEFS). Presence and severity of neuropathic pain will evaluate according to Douleur Neuropathique 4 questionnare (DN4). To identify the outcomes of the treatment modalities, pre-treatment, post-treatment 1st month and 3th-month scores will be used. Patients with comorbidities that prevented interventional treatment (e.g., inflammatory diseases, uncontrolled diabetes mellitus, uncontrolled hypertension, malignancy, pregnancy, and severe psychiatric disorders), patients with other diagnoses that may cause hip and leg pain (e.g.,lumbar disc herniation, sciatic nerve injury history, sacroiliac and hip joint pathologies) those aged under 18 years old and patients who did not accept interventional or physical therapy modalities are going to exclude from the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: ultrasound guided dry needlingAll patients in group 1 (n:22) had DN treatment applied to the piriformis muscle once a week for a total of 3 times under US guidance. |
| 2 | – | Procedure: ultrasound guided dry needlingAll patients in group 2(n:22) had exercise programme for 3 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients were divided into two groups as those who will accept DN treatment (Group 1 -n: 22) and those who will have physical exercise treatment (Group 2- n: 22). All patients in group 1 will have DN treatment to the piriformis muscle once a week for a total of 3 times under US guidance.
Key inclusion criteria (2 listed)
- Patients with isolated Piriformis Muscle Syndrome
- The diagnosis is based on patient's history and physical examination, bearing positive FAIR (flexion, adduction, internal rotation) test and/or tenderness or trigger point at the priformis muscle area and/or revealing the pain with maneuvers; such as Freiberg's maneuver (forceful internal rotation of the extended thigh in the supine position), Beatty's maneuver (actively abducting the affected thigh in the lateral decubitus position) and Pace's maneuver (resisted abduction of both thighs in the seated position).
Key exclusion criteria (4 listed)
- Patients with comorbidities that prevented interventional treatment (e.g., inflammatory diseases, uncontrolled diabetes mellitus, uncontrolled hypertension, malignancy, pregnancy, and severe psychiatric disorders),
- Patients with other diagnoses that may cause hip and leg pain (e.g.,lumbar disc herniation, sciatic nerve injury history, sacroiliac and hip joint pathologies)
- Aged under 18 years old
- Patients who will not accept interventional or physical therapy modalities
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 |
|---|---|---|
| ultrasound guided dry needlingAlso: exercise programmeDry needling was applied in the intervention room with sterile conditions the patient in the prone position.The low frequency (2-5 MHz) transducer is placed in the gluteal region in a slightly oblique position and sonographic scanning is started. First, the large mountain shadow of the iliac crest and gluteus maximus muscle is sonographically visualized in the midline. Then the transducer is shifted inferiorly until the sciatic notch is visualized. When the sciatic notch, sciatic nerve and the pear-shaped piriformis muscle above it are visualized, the patient's knee is flexed and the leg is rotated internally and externally, and the typical sliding motion of the piriformis muscle is observed. After the target point is determined, a 22 G spinal needle is applied from lateral to medial or from medial to lateral with in plane technique. The needle is inserted and withdrawn several times until the switch response in the piriformis muscle is observed and extinguished | Procedure or surgery | 1, 2 |
Primary outcome
Visuel Analogue Scale
Time frame: change from baseline VAS scores at 3 months
Overall pain severity was measured by using a 0 to 100 mm scale visual analogue scale (VAS).
3 secondary outcomes
Oswestry Disability Index (ODI) questionnaire,
Time frame: change from baseline ODI scores at 3 months
lower extremity functional scale (LEFS)
Time frame: change from baseline LEFS scores at 3 months
Douleur Neuropathique 4 questionnare (DN4)
Time frame: change from baseline DN4 scores at 3 months
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 27 Jul 2023.
- Results publication: PubMed 31415092Tabatabaiee A, Takamjani IE, Sarrafzadeh J, Salehi R, Ahmadi M. Ultrasound-guided dry needling decreases pain in patients with piriformis syndrome. Muscle Nerve. 2019 Nov;60(5):558-565. doi: 10.1002/mus.26671. Epub 2019 Aug 27.
- Results publication: PubMed 30228811Fusco P, Di Carlo S, Scimia P, Degan G, Petrucci E, Marinangeli F. Ultrasound-guided Dry Needling Treatment of Myofascial Trigger Points for Piriformis Syndrome Management: A Case Series. J Chiropr Med. 2018 Sep;17(3):198-200. doi: 10.1016/j.jcm.2018.04.002. Epub 2018 Aug 26.
- Results publication: PubMed 25794202Misirlioglu TO, Akgun K, Palamar D, Erden MG, Erbilir T. Piriformis syndrome: comparison of the effectiveness of local anesthetic and corticosteroid injections: a double-blinded, randomized controlled study. Pain Physician. 2015 Mar-Apr;18(2):163-71.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Piriformis Muscle Syndrome and Dry Needling, run by Tepecik Training and Research Hospital 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 2 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 27 Jul 2023. 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. 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?
Visuel Analogue Scale (time frame: change from baseline VAS scores at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05962515, which also lists 3 linked publications.
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 27 Jul 2023.