Deep Gluteal SyndromeNCT04387877
Graston Technique in Deep Gluteal Syndrome
A study testing Graston in people with Deep Gluteal Syndrome and Piriformis Syndrome, run by Koç University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Deep Gluteal Syndrome, Piriformis Syndrome
- What is being tested?
- Graston
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2019to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Active psychiatric disease
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- Noncompensated chronic heart/liver/renal deficiency or vascular/tumoral disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koc University School of Medicine
Istanbul, 34010
About this study
Official title: The Effect of Graston Technique in Deep Gluteal Syndrome
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.
Read the 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.
- Conditions
- Deep Gluteal Syndrome, Piriformis Syndrome
- Being tested
- Graston, Sham
- Keywords
- deep gluteal syndrome, graston, elastography, piriformis syndrome, miyofascial release
- Medical subject headings
- Hip socket neuropathy, Piriformis Muscle Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrastonDevice
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
ShamOther
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
| Study group | Role | What they receive |
|---|---|---|
| Graston Group | Experimental | 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. Receives: Device: Graston |
| Sham Group | Sham comparator | 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) Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (4)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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™)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start30 Sep 2019
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Deep Gluteal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ozden Ozyemisci Taskiran, Prof, Principal investigator, Koc University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387877
- Sponsor's protocol ID
- 2019.308.IRB1.052
- Status last verified
- Feb 2022
- First submitted
- 10 May 2020
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martin HD, Reddy M, Gomez-Hoyos J. Deep gluteal syndrome. J Hip Preserv Surg. 2015 Jul;2(2):99-107. doi: 10.1093/jhps/hnv029. Epub 2015 Jun 6.
PubMed 27011826Natsis K, Totlis T, Konstantinidis GA, Paraskevas G, Piagkou M, Koebke J. Anatomical variations between the sciatic nerve and the piriformis muscle: a contribution to surgical anatomy in piriformis syndrome. Surg Radiol Anat. 2014 Apr;36(3):273-80. doi: 10.1007/s00276-013-1180-7. Epub 2013 Jul 31.
PubMed 23900507Carro LP, Hernando MF, Cerezal L, Navarro IS, Fernandez AA, Castillo AO. Deep gluteal space problems: piriformis syndrome, ischiofemoral impingement and sciatic nerve release. Muscles Ligaments Tendons J. 2016 Dec 21;6(3):384-396. doi: 10.11138/mltj/2016.6.3.384. eCollection 2016 Jul-Sep.
PubMed 28066745Santamato A, Micello MF, Valeno G, Beatrice R, Cinone N, Baricich A, Picelli A, Panza F, Logroscino G, Fiore P, Ranieri M. Ultrasound-Guided Injection of Botulinum Toxin Type A for Piriformis Muscle Syndrome: A Case Report and Review of the Literature. Toxins (Basel). 2015 Aug 10;7(8):3045-56. doi: 10.3390/toxins7083045.
PubMed 26266421Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.
PubMed 25724849Han SK, Kim YS, Kim TH, Kang SH. Surgical Treatment of Piriformis Syndrome. Clin Orthop Surg. 2017 Jun;9(2):136-144. doi: 10.4055/cios.2017.9.2.136. Epub 2017 May 8.
PubMed 28567214Misirlioglu 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.
PubMed 25794202McKenney K, Elder AS, Elder C, Hutchins A. Myofascial release as a treatment for orthopaedic conditions: a systematic review. J Athl Train. 2013 Jul-Aug;48(4):522-7. doi: 10.4085/1062-6050-48.3.17. Epub 2013 Apr 3.
PubMed 23725488Looney B, Srokose T, Fernandez-de-las-Penas C, Cleland JA. Graston instrument soft tissue mobilization and home stretching for the management of plantar heel pain: a case series. J Manipulative Physiol Ther. 2011 Feb;34(2):138-42. doi: 10.1016/j.jmpt.2010.12.003.
PubMed 21334547Moon JH, Jung JH, Won YS, Cho HY. Immediate effects of Graston Technique on hamstring muscle extensibility and pain intensity in patients with nonspecific low back pain. J Phys Ther Sci. 2017 Feb;29(2):224-227. doi: 10.1589/jpts.29.224. Epub 2017 Feb 24.
PubMed 28265144Huang, H.P., et al., Gait Analysis of Patients with Unilateral Piriformis Syndrome. IFMBE Proceedings, 2015. 47: p. 104-106.
Sarvazyan A, Hall TJ, Urban MW, Fatemi M, Aglyamov SR, Garra BS. AN OVERVIEW OF ELASTOGRAPHY - AN EMERGING BRANCH OF MEDICAL IMAGING. Curr Med Imaging Rev. 2011 Nov;7(4):255-282. doi: 10.2174/157340511798038684.
PubMed 22308105Creze M, Nordez A, Soubeyrand M, Rocher L, Maitre X, Bellin MF. Shear wave sonoelastography of skeletal muscle: basic principles, biomechanical concepts, clinical applications, and future perspectives. Skeletal Radiol. 2018 Apr;47(4):457-471. doi: 10.1007/s00256-017-2843-y. Epub 2017 Dec 9.
PubMed 29224123Deshmukh S, Abboud SF, Grant T, Omar IM. High-resolution ultrasound of the fascia lata iliac crest attachment: anatomy, pathology, and image-guided treatment. Skeletal Radiol. 2019 Sep;48(9):1315-1321. doi: 10.1007/s00256-018-3141-z. Epub 2019 Jan 7.
PubMed 30617717Whittaker JL, Emery CA. Sonographic measures of the gluteus medius, gluteus minimus, and vastus medialis muscles. J Orthop Sports Phys Ther. 2014 Aug;44(8):627-32. doi: 10.2519/jospt.2014.5315. Epub 2014 Jul 16.
PubMed 25029916
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Graston Technique in Deep Gluteal Syndrome
- ClinicalTrials.gov ID
- NCT04387877
- Acronym / sponsor ID
- 2019.308.IRB1.052
- Conditions
- Deep Gluteal Syndrome, Piriformis Syndrome
- Keywords
- deep gluteal syndrome, graston, elastography, piriformis syndrome, miyofascial release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graston Group | Experimental | Device: GrastonGraston 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 Group | Sham comparator | Other: ShamSham 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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GrastonGraston 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 | Device | Graston Group |
| ShamSham 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 | Other | Sham Group |
Primary outcome
Oswestry Disability Index
Time frame: 4 weeks
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.
4 secondary outcomes
Visual Analog Scale
Time frame: 4 weeks
Nottingham Health Profile
Time frame: 4 weeks
Shearwave Elastography
Time frame: 4 weeks
Gait Analyze
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Results publication: PubMed 27011826Martin HD, Reddy M, Gomez-Hoyos J. Deep gluteal syndrome. J Hip Preserv Surg. 2015 Jul;2(2):99-107. doi: 10.1093/jhps/hnv029. Epub 2015 Jun 6.
- Results publication: PubMed 23900507Natsis K, Totlis T, Konstantinidis GA, Paraskevas G, Piagkou M, Koebke J. Anatomical variations between the sciatic nerve and the piriformis muscle: a contribution to surgical anatomy in piriformis syndrome. Surg Radiol Anat. 2014 Apr;36(3):273-80. doi: 10.1007/s00276-013-1180-7. Epub 2013 Jul 31.
- Results publication: PubMed 28066745Carro LP, Hernando MF, Cerezal L, Navarro IS, Fernandez AA, Castillo AO. Deep gluteal space problems: piriformis syndrome, ischiofemoral impingement and sciatic nerve release. Muscles Ligaments Tendons J. 2016 Dec 21;6(3):384-396. doi: 10.11138/mltj/2016.6.3.384. eCollection 2016 Jul-Sep.
- Results publication: PubMed 26266421Santamato A, Micello MF, Valeno G, Beatrice R, Cinone N, Baricich A, Picelli A, Panza F, Logroscino G, Fiore P, Ranieri M. Ultrasound-Guided Injection of Botulinum Toxin Type A for Piriformis Muscle Syndrome: A Case Report and Review of the Literature. Toxins (Basel). 2015 Aug 10;7(8):3045-56. doi: 10.3390/toxins7083045.
- Results publication: PubMed 25724849Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.
- Results publication: PubMed 28567214Han SK, Kim YS, Kim TH, Kang SH. Surgical Treatment of Piriformis Syndrome. Clin Orthop Surg. 2017 Jun;9(2):136-144. doi: 10.4055/cios.2017.9.2.136. Epub 2017 May 8.
- Results publication: PubMed 25794202Misirlioglu 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.
- Results publication: PubMed 23725488McKenney K, Elder AS, Elder C, Hutchins A. Myofascial release as a treatment for orthopaedic conditions: a systematic review. J Athl Train. 2013 Jul-Aug;48(4):522-7. doi: 10.4085/1062-6050-48.3.17. Epub 2013 Apr 3.
- Results publication: PubMed 21334547Looney B, Srokose T, Fernandez-de-las-Penas C, Cleland JA. Graston instrument soft tissue mobilization and home stretching for the management of plantar heel pain: a case series. J Manipulative Physiol Ther. 2011 Feb;34(2):138-42. doi: 10.1016/j.jmpt.2010.12.003.
- Results publication: PubMed 28265144Moon JH, Jung JH, Won YS, Cho HY. Immediate effects of Graston Technique on hamstring muscle extensibility and pain intensity in patients with nonspecific low back pain. J Phys Ther Sci. 2017 Feb;29(2):224-227. doi: 10.1589/jpts.29.224. Epub 2017 Feb 24.
- Results publicationHuang, H.P., et al., Gait Analysis of Patients with Unilateral Piriformis Syndrome. IFMBE Proceedings, 2015. 47: p. 104-106.
- Results publication: PubMed 22308105Sarvazyan A, Hall TJ, Urban MW, Fatemi M, Aglyamov SR, Garra BS. AN OVERVIEW OF ELASTOGRAPHY - AN EMERGING BRANCH OF MEDICAL IMAGING. Curr Med Imaging Rev. 2011 Nov;7(4):255-282. doi: 10.2174/157340511798038684.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozden Ozyemisci Taskiran, Prof principal investigator
Koc University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graston in people with Deep Gluteal Syndrome and Piriformis Syndrome, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04387877, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022; AzTrials last refreshed its copy on 31 Oct 2026.