Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05962515
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2023-07-17
Brief Title:
Efficacy of Ultrasound-Guided Dry Needling Therapy and Exercise in Piriformis Muscle Syndrome
Sponsor:
Tepecik Training and Research Hospital
Organization:
Tepecik Training and Research Hospital
Study Overview
Official Title:
Evaluation of the Efficacy of Ultrasound-Guided Dry Needling Therapy and Exercise Programme in Piriformis Muscle Syndrome
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 nerveIn 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 patients history and physical examination bearing positive FAIR test andor tenderness or trigger point at the priformis muscle area andor revealing the pain with maneuvers such as Freibergs maneuver Beattys maneuver and Paces 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 formThe patients will divide into two groups group 1 n22will have DN treatment to the piriformis muscle once a week for a total of 3 times under US guidance all patients in group 2 n22 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 eg inflammatory diseases uncontrolled diabetes mellitus uncontrolled hypertension malignancy pregnancy and severe psychiatric disorders patients with other diagnoses that may cause hip and leg pain eglumbar 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None