Efficacy of Ultrasound-Guided Dry Needling Therapy and Exercise in Piriformis Muscle Syndrome
Evaluation of the Efficacy of Ultrasound-Guided Dry Needling Therapy and Exercise Programme in Piriformis Muscle Syndrome
1 other identifier
observational
44
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedFirst Submitted
Initial submission to the registry
July 17, 2023
CompletedFirst Posted
Study publicly available on registry
July 27, 2023
CompletedJuly 27, 2023
July 1, 2023
1.2 years
July 17, 2023
July 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visuel Analogue Scale
Overall pain severity was measured by using a 0 to 100 mm scale visual analogue scale (VAS).
change from baseline VAS scores at 3 months
Secondary Outcomes (3)
Oswestry Disability Index (ODI) questionnaire,
change from baseline ODI scores at 3 months
lower extremity functional scale (LEFS)
change from baseline LEFS scores at 3 months
Douleur Neuropathique 4 questionnare (DN4)
change from baseline DN4 scores at 3 months
Study Arms (2)
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.
2
All patients in group 2(n:22) had exercise programme for 3 weeks.
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tepecik Training and Research Hospital
Izmir, 35000, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 31415092RESULTFusco 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.
PMID: 30228811RESULTMisirlioglu 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.
PMID: 25794202RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pain Physician, MD
Study Record Dates
First Submitted
July 17, 2023
First Posted
July 27, 2023
Study Start
January 20, 2022
Primary Completion
April 1, 2023
Study Completion
July 1, 2023
Last Updated
July 27, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share