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Graston Technique in Deep Gluteal Syndrome

Primary Purpose

Deep Gluteal Syndrome, Piriformis Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Graston
Sham
Sponsored by
Koç University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Gluteal Syndrome focused on measuring deep gluteal syndrome, graston, elastography, piriformis syndrome, miyofascial release

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between the ages of 18 and 70
  • Having unilateral hip and/or leg pain with positive FAIR (flexion, adduction, internal rotation) test
  • Tenderness and/or trigger point at the Piriformis with deep palpation

Exclusion Criteria:

  • Neurological deficit
  • Limited lumbar and/or hip range of motion
  • Previous surgery of the lumbar and/ or hip region
  • Being in gestational or lactational period
  • Body mass index greater than 35
  • Inflammatory or infectious disease
  • Active psychiatric disease
  • Uncontrolled hypertension
  • Uncontrolled diabetes mellitus
  • Noncompensated chronic heart/liver/renal deficiency or vascular/tumoral disease.

Sites / Locations

  • Koc University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Graston Group

Sham Group

Arm Description

Graston technique will be applied on the lateral and posterior myofascial chain area tensor fascia lata, gluteus medius, gluteus minimus, gluteus maximus, hamstring, gastrocnemius and soleus muscles) in 15 minutes.

Sham graston technique will be applied on lateral and posterior myofascial chain area (tensor fascia lata, gluteus medius, gluteus minimus, gluteus maximus, hamstring, gastrocnemius and soleus muscles) in 15 minutes. (Sham graston technique will be applied to the patient by partially touching the muscle or fascia region via ultrasound gel with the flat part of the Graston tool so as not to provide the activity of the fascia)

Outcomes

Primary Outcome Measures

Oswestry Disability Index
Oswestry Disability Index (ODI), measures the level of disability. It consists of 10 items questioning the severity of pain, self-care, lifting and carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. Its Turkish version is validated in 2004. Items are scored between 0 and 5, and the total score is multiplied by two. The maximum score is "100". As the total score increases, the level of disability increases.

Secondary Outcome Measures

Visual Analog Scale
It is a scale consisting of a 10-centimeter line that evaluates the intensity of pain. Starting point of scale, 0 = no pain, end point 10 = expressed as the most severe pain encountered in life. Patients are asked to mark the severity of pain on the line. When calculating, the distance between the marked point and the starting point is measured in centimeters. Increasing the score means that the pain intensity increases.
Nottingham Health Profile
Nottingham health profile is a general quality-of-life questionnaire that measures health problems that a person perceives and how these problems affect normal and daily activities. The questionnaire consists of 38 items and evaluates 6 dimensions related to health: energy, pain, emotional reactions, sleep, social isolation and physical activity. Questions are answered as yes or no. Scoring is done in every section between 0-100. 0 indicates the best health status, 100 worst health status. The total Nottingham Health Profile score is obtained from the sum of the sub-scores. Turkish validity and reliability were shown in 2000.
Shearwave Elastography
Thickness and shear wave elastography (SWE) of tensor fascia lata (TFL), proximal and distal part of iliotibial band (ITB) on the affected side of the body in side lying position were evaluated at rest using GE LOGIQ E9 XDclear ultrasound device equipped with lineer array transducer (9L-D, B-mode, frequency 9-5 MHz). We measured shear wave velocity (SWV) (expressed in m/s) and young modulus (in kPa). Three 5 mm diameter region of interest (ROI) was located most homogeneous part of the color map. For sufficient image quality and shear wave signals a large amount of gel was used and minimum pressure was applied on the probe. The positions of transducers were selected after browsing previous studies and testing on different subjects. The same specialist performed all the evaluation on the same subjects before and after treatment.
Gait Analyze
The Noraxon myoMOTION™ software module features a medically accurate avatar paired with a toolset for analyzing pre-processed motion records. Real-time data is automatically synchronized in an all-in-one analysis. In our study, each subject is stick with 13 retroreflective markers on the bony landmarks for tracking the motions of the body segments, including the head, each superor iliac spine, each middle of humerus, each wrist, each metacarp, head of fibula, each navicular tuberosity. By using the 1-cameras motion analysis system (The Noraxon myoMOTION™) and measuring the ground reaction forces with a forceplate (The Noraxon myoPressure™)

Full Information

First Posted
May 10, 2020
Last Updated
June 29, 2022
Sponsor
Koç University
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1. Study Identification

Unique Protocol Identification Number
NCT04387877
Brief Title
Graston Technique in Deep Gluteal Syndrome
Official Title
The Effect of Graston Technique in Deep Gluteal Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koç University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Deep gluteal syndrome describes the presence of pain in the buttock caused from non-discogenic and extrapelvic entrapment of the sciatic nerve. The Graston Technique (GT) is a kind of manual therapy technique known as soft-tissue instrument-assisted mobilization. Instruments help to perform massage/scraping of the skin and miyofascia gently. The aim of this study is to investigate additive effect of GT applied to the lateral and posterior fascia to the exercise program in patients with deep gluteal syndrome on pain and disability.
Detailed Description
Deep gluteal syndrome describes the presence of pain in the buttock caused from non-discogenic and extrapelvic entrapment of the sciatic nerve. Several structures can be involved in sciatic nerve entrapment within the gluteal space [1]. There are many anatomical variations between the sciatic nerve and piriformis muscle (PM) [2]. Some authors have associated deep gluteal pain syndrome with piriformis syndrome (PS) [3]. Chronic buttock pain caused by the musculoskeletal pathologies of the PM such as myofascial pain or pinching of the sciatic nerve by the PM during certain leg and hip maneuvers [4]. In most cases, PS is widely believed to be myofascial in origin [5]. Treatment of PS starts with conservative pharmacotherapy with nonsteroidal anti-inflammatory drugs, muscle relaxants, and neuropathic pain agents and continues with physical therapy, which includes stretching of the PM to correct the underlying pathology [6]. If the conservative regimen fails, then more aggressive therapy, such as local injection of PM, which may reconfirm the diagnosis through therapeutic success, should be performed [7]. Myofascial release is a specific manual therapy method claimed to be useful for treating skeletal muscle immobility and pain by relaxing contracted muscles, improving blood, oxygen, and lymphatic circulation, and stimulating the stretch reflex in muscles [8]. The Graston Technique (GT) is a form of manual therapy known as soft-tissue instrument-assisted mobilization. It is one of a number of manual therapy approaches that uses instruments with a specialized form of massage/scraping the skin and miyofascia gently [9]. This technique seems to have the therapeutic effects of inhibiting the adhesion of tissue, increasing the number of fibroblasts, and promoting collagen synthesis [10]. Gait analysis has been widely used in the diagnosis of locomotors pathology and the assessment of treatment. But study of gait on deep gluteal syndrome remain unclear. 3-D motion analysis can be used to measure the kinematic and kinetic together with temporal-spatial parameters data of patients with deep gluteal syndrome during walking. Patients with deep gluteal syndrome show significant increase gait speed and cadence, and peak extensor moments with increased flexion, abduction and internal rotation at the hip during the whole gait cycle [11]. Shear Wave elastography is an imaging technique which quantifies tissue stiffness by measuring the speed of shear waves in tissue. It is a new advanced dynamic ultrasound technique that provides information about the stiffness / consistency of the tissue by measuring the degree of strain in the tissue without external force [12]. The aim of this study is to investigate the additive effect of GT to the exercise program in patients with deep gluteal syndrome on pain and disability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Gluteal Syndrome, Piriformis Syndrome
Keywords
deep gluteal syndrome, graston, elastography, piriformis syndrome, miyofascial release

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Graston Group
Arm Type
Experimental
Arm Description
Graston technique will be applied on the lateral and posterior myofascial chain area tensor fascia lata, gluteus medius, gluteus minimus, gluteus maximus, hamstring, gastrocnemius and soleus muscles) in 15 minutes.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
Sham graston technique will be applied on lateral and posterior myofascial chain area (tensor fascia lata, gluteus medius, gluteus minimus, gluteus maximus, hamstring, gastrocnemius and soleus muscles) in 15 minutes. (Sham graston technique will be applied to the patient by partially touching the muscle or fascia region via ultrasound gel with the flat part of the Graston tool so as not to provide the activity of the fascia)
Intervention Type
Device
Intervention Name(s)
Graston
Intervention Description
Graston technique will be applied on the lateral and posterior fascia (tensor fascia lata, gluteus medius, gluteus minimus, gluteus maximus, hamstring, gastrocnemius and soleus muscles) in 15 minutes. For the first 2 weeks; dorsolumbar stabilization, straight and side leg lifting, gluteal setting, side walking exercises For the second 2 weeks; dorsolumbar stabilization counting on spot, straight and side leg lifting, gluteal setting, side walking exercises with 0.5 kg weight on the ankle, piriformis, tensor fascia lata and hamstring stretching exercises
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Sham graston technique will be applied on lateral and posterior fascia (tensor fascia lata, gluteus medius, gluteus minimus, gluteus maximus, hamstring, gastrocnemius and soleus muscles) in 15 minutes. (Sham graston technique will be applied by partially touching the skin overlying the muscle or fascia region via ultrasound gel with the flat part of the Graston instrument so as not to provide any activity of the fascia) For the first 2 weeks; dorsolumbar stabilization, counting on spot, straight and side leg lifting, gluteal setting, side walking exercises For the second 2 weeks; dorsolumbar stabilization counting on spot, straight and side leg lifting, gluteal setting, side walking exercises with 0.5 kg weight on the ankle, piriformis, tensor fascia lata and hamstring stretching exercises
Primary Outcome Measure Information:
Title
Oswestry Disability Index
Description
Oswestry Disability Index (ODI), measures the level of disability. It consists of 10 items questioning the severity of pain, self-care, lifting and carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. Its Turkish version is validated in 2004. Items are scored between 0 and 5, and the total score is multiplied by two. The maximum score is "100". As the total score increases, the level of disability increases.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Visual Analog Scale
Description
It is a scale consisting of a 10-centimeter line that evaluates the intensity of pain. Starting point of scale, 0 = no pain, end point 10 = expressed as the most severe pain encountered in life. Patients are asked to mark the severity of pain on the line. When calculating, the distance between the marked point and the starting point is measured in centimeters. Increasing the score means that the pain intensity increases.
Time Frame
4 weeks
Title
Nottingham Health Profile
Description
Nottingham health profile is a general quality-of-life questionnaire that measures health problems that a person perceives and how these problems affect normal and daily activities. The questionnaire consists of 38 items and evaluates 6 dimensions related to health: energy, pain, emotional reactions, sleep, social isolation and physical activity. Questions are answered as yes or no. Scoring is done in every section between 0-100. 0 indicates the best health status, 100 worst health status. The total Nottingham Health Profile score is obtained from the sum of the sub-scores. Turkish validity and reliability were shown in 2000.
Time Frame
4 weeks
Title
Shearwave Elastography
Description
Thickness and shear wave elastography (SWE) of tensor fascia lata (TFL), proximal and distal part of iliotibial band (ITB) on the affected side of the body in side lying position were evaluated at rest using GE LOGIQ E9 XDclear ultrasound device equipped with lineer array transducer (9L-D, B-mode, frequency 9-5 MHz). We measured shear wave velocity (SWV) (expressed in m/s) and young modulus (in kPa). Three 5 mm diameter region of interest (ROI) was located most homogeneous part of the color map. For sufficient image quality and shear wave signals a large amount of gel was used and minimum pressure was applied on the probe. The positions of transducers were selected after browsing previous studies and testing on different subjects. The same specialist performed all the evaluation on the same subjects before and after treatment.
Time Frame
4 weeks
Title
Gait Analyze
Description
The Noraxon myoMOTION™ software module features a medically accurate avatar paired with a toolset for analyzing pre-processed motion records. Real-time data is automatically synchronized in an all-in-one analysis. In our study, each subject is stick with 13 retroreflective markers on the bony landmarks for tracking the motions of the body segments, including the head, each superor iliac spine, each middle of humerus, each wrist, each metacarp, head of fibula, each navicular tuberosity. By using the 1-cameras motion analysis system (The Noraxon myoMOTION™) and measuring the ground reaction forces with a forceplate (The Noraxon myoPressure™)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between the ages of 18 and 70 Having unilateral hip and/or leg pain with positive FAIR (flexion, adduction, internal rotation) test Tenderness and/or trigger point at the Piriformis with deep palpation Exclusion Criteria: Neurological deficit Limited lumbar and/or hip range of motion Previous surgery of the lumbar and/ or hip region Being in gestational or lactational period Body mass index greater than 35 Inflammatory or infectious disease Active psychiatric disease Uncontrolled hypertension Uncontrolled diabetes mellitus Noncompensated chronic heart/liver/renal deficiency or vascular/tumoral disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozden Ozyemisci Taskiran, Prof
Organizational Affiliation
Koc University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Koc University School of Medicine
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
27011826
Citation
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Graston Technique in Deep Gluteal Syndrome

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