Clinical trial NCT04387877: Graston Technique in Deep Gluteal Syndrome
Official title: The Effect of Graston Technique in Deep Gluteal Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Gluteal Syndrome
Piriformis Syndrome
Keywords: deep gluteal syndrome
graston
elastography
piriformis syndrome
miyofascial release
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: 4 weeks
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 4 weeks
measure: Nottingham Health Profile
timeFrame: 4 weeks
measure: Shearwave Elastography
timeFrame: 4 weeks
measure: Gait Analyze
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University School of Medicine
Study officials:
affiliation: Koc University School of Medicine
name: Ozden Ozyemisci Taskiran, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Natsis 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.
citation: Carro 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.
citation: Santamato 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.
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citation: Misirlioglu 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.
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citation: Looney 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.
citation: Moon 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.
citation: Huang, H.P., et al., Gait Analysis of Patients with Unilateral Piriformis Syndrome. IFMBE Proceedings, 2015. 47: p. 104-106.
citation: 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.
citation: Creze 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.
citation: Deshmukh 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.
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