Graston Technique in Deep Gluteal Syndrome

NCT04387877 | Completed

• 1 other identifier: 2019.308.IRB1.052
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Deep Gluteal Syndrome; Piriformis Syndrome

Keywords

deep gluteal syndrome; graston; elastography; piriformis syndrome; miyofascial release

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (4)

• Visual Analog Scale

  4 weeks

• Nottingham Health Profile

  4 weeks

• Shearwave Elastography

  4 weeks

• Gait Analyze

  4 weeks

Study Arms (2)

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.

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)

Other: Sham

Interventions

Graston DEVICE

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

Graston Group

Sham OTHER

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

Sham Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University School of Medicine

Istanbul, 34010, Turkey (Türkiye)

Location

Related Publications (15)

• 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.

  PMID: 27011826 RESULT

• 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.

  PMID: 23900507 RESULT

• 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.

  PMID: 28066745 RESULT

• 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.

  PMID: 26266421 RESULT

• Shah 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.

  PMID: 25724849 RESULT

• Han 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.

  PMID: 28567214 RESULT

• 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.

  PMID: 25794202 RESULT

• McKenney 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.

  PMID: 23725488 RESULT

• 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.

  PMID: 21334547 RESULT

• 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.

  PMID: 28265144 RESULT

• Huang, H.P., et al., Gait Analysis of Patients with Unilateral Piriformis Syndrome. IFMBE Proceedings, 2015. 47: p. 104-106.

  RESULT

• 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.

  PMID: 22308105 RESULT

• 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.

  PMID: 29224123 RESULT

• 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.

  PMID: 30617717 RESULT

• Whittaker 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.

  PMID: 25029916 RESULT

MeSH Terms

Conditions

Hip socket neuropathy; Piriformis Muscle Syndrome

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Study Officials

• Ozden Ozyemisci Taskiran, Prof

  Koc University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 14, 2020
• Study Start: September 30, 2019
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-02

Locations

TU (1)