The Relationship Between Ambulation Capacity and Piriformis Muscle in Patients With Chronic Spinal Cord Injury

The Relationship Between Ambulation Capacity and Piriformis Muscle in Patients With Chronic Spinal Cord Injury: A Controlled, Clinical and Sonographic Study

Spinal cord injury (SCI) is a neurological condition causing paralysis, sensory abolishmentS and deficits including circulatory, respiratory, otonomic nervous systems, bowel and bladder functions. For patients with SCI, reducing disability, limitations of the impairment and regaining the walking ability are the main rehabilitation goals. There many prognostic factors effecting the recovery and ambulation capacity of patients.

The piriformis muscle (PM) is placed posterior to the hip joint, originates on the anterior surface of the sacrum and the sacrotuberous ligament and passes out of the pelvis through the greater sciatic foramen and separates the foramen into two spaces. The PM is the solely muscle coursing transversely throughout the greater sciatic notch, and it is the main landmark to all the important neurovasculer structures that pass from the pelvis to the gluteal region. PM serves as a hip abductor when the hip is flexed and as a hip external rotator when the hip is extended. It is innervated by branches of the posterior division of the ventral rami of S1, S2 and is the largest muscle among the deep, short external rotators of the hip and provides postural stability while standing and walking. PM has also a functional importance as it connects the sacroiliac joint and hip joint. For these reasons morphology of PM may have a clinical importance for SCI patients whom can walk.

Ultrasonography is radiation-free, noninvasive, available technique that can be used to measure muscle thickness in the monitoring and management of muscle changes during rehabilitation.

The aim of our study is to evaluate the relationship between the PM and the ambulation pattern of motor incomplete patients with chronic SCI. To the best of our knowledge, this is the first study evaluating PM in patients with SCI.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Ultrasonographic evaluation

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Özlem Köroğlu; Phone Number: +905056005504; Email: drozlemkoroglu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

60 patients aged 18-65 years with diagnosis of paraplegia

Description

Inclusion Criteria:

• Being between the ages of 18-65
• Diagnosis of motor incomplete paraplegia at C or D level according to the spinal cord injury classification of the American Spinal Injury Association (ASIA) Impairment Scale with a neurological injury level between T2-S1

Exclusion Criteria:

• Being under the age of 18 and over the age of 65
• Having joint contracture in the legs
• Unstable medical conditions
• Severe osteoporosis and high fracture risk
• Sacral or coccygeal grade 2 and higher pressure ulcers
• Peripheral neuropathy,
• Psychiatric disorder or cognitive problems

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Motor incomplete paraplegia patients; Participants with the age of 18 - 65, were selected for the study based on the following inclusion criteria: diagnosis of motor incomplete paraplegia at C or D level according to the spinal cord injury classification of the American Spinal Injury Association (ASIA) Impairment Scale with a neurological injury level between T2-S1.	Other: Ultrasonographic evaluation; Ultrasonographic evaluation for the thickness of piriformis muscle
Non-ambulatory patients with complete spinal cord injury; Participants with the age of 18 - 65, were selected for the study based on the following inclusion criteria: non-ambulatory patients with diagnosis of motor complete paraplegia at A level according to the spinal cord injury classification of the American Spinal Injury Association (ASIA) Impairment Scale with a neurological injury level between T2-S1.	Other: Ultrasonographic evaluation; Ultrasonographic evaluation for the thickness of piriformis muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
piriformis muscle thickness with ultrasonographic evaluation	The thickness of piriformis muscle was measured by using a curvilinear transducer first placing in the lateral margin of the sacrum. The transducer was moved inferolaterally toward the greater trochanter until the medial end of the transducer remained at the lateral end of the sacrum. Piriformis muscle thickness was measured in the medial part of the tip of the ischium, that was parallel to the longitudinal plane at the sciatic notch with the patient's leg was abducted 45 degrees when the piriformis muscle was seen as a deep hypoechoic appearance beneath the gluteus maximus muscle.	Through study completion, an average of one and a half months

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Investigators: Principal Investigator: Özlem Köroğlu, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 13, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: spinal cord injury; piriformis muscle; ultrasonographic evaluation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No