Efficacy of Ultrasound-Guided Dry Needling Therapy and Exercise in Piriformis Muscle Syndrome

July 26, 2023 updated by: derya guner, Tepecik Training and Research Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey, 35000
        • Tepecik Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: ultrasound guided dry needling
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
Other Names:
  • exercise programme
2
All patients in group 2(n:22) had exercise programme for 3 weeks.
Procedure: ultrasound guided dry needling
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
Other Names:
  • exercise programme

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
change from baseline VAS scores at 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI) questionnaire,
Time Frame: change from baseline ODI scores at 3 months
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.
change from baseline ODI scores at 3 months
lower extremity functional scale (LEFS)
Time Frame: change from baseline LEFS scores at 3 months
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
change from baseline LEFS scores at 3 months
Douleur Neuropathique 4 questionnare (DN4)
Time Frame: change from baseline DN4 scores at 3 months
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.
change from baseline DN4 scores at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tepecik Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022/2/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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