Clinical trial NCT06664931: Muscle Energy Versus Mulligan Techniques in Treating Patients With Cervical Spondylosis
Official title: Muscle Energy Versus Mulligan Techniques in Treating Patients With Cervical Spondylosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Spondylosis
Mulligan Mobilization
SNAGs
Muscle Energy Technique
Post Isometric Relaxation
Keywords: Mulligan Mobilization
Mobilization with Movement
SNAGs
Muscle Energy Technique
Post isometric relaxation
Cervical Spondylosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Model Description
Primary purpose: TREATMENT

Brief summary: This study will be aimed to answer the following questions:

Which technique, MET or MMT, is more effective in reducing pain, increasing range of motion (ROM), improving proprioception, and enhancing functional ability in individuals with CS?

It will be assumed that:

1. All participants will adhere to study instructions and procedures.
2. All participants will be evaluated under standardized conditions.

Detailed description: Cervical spondylosis (CS) is a highly prevalent age-related condition (95%), that affects the joints and discs of the cervical spine. By age 65, nearly all individuals experience some degree of degeneration, characterized by disc breakdown and enlarged facet joints. While aging is the primary cause, injuries can accelerate this process in younger populations.

Significance of the Study Age-related degenerative spinal changes are almost widespread. Population-based studies have shown that approximately 80 to 90% of people have disk degeneration on magnetic resonance imaging (MRI) by the age of 50 years.

A global burden review estimates that over 300 million people worldwide had mechanical neck pain lasting at least 3 months in 2015.

Clinical features of spondylosis are more common in men than in women, with a peak incidence between the ages of 40 and 60 years for both men and women.

Cervical spondylosis commonly affects the middle and lower cervical vertebrae (C5-C6 and C6-C7), although higher levels may also be involved. Neck pain is the most prominent symptom. CS can affect all cervical components (i.e., the spinal cord, spinal vasculature, and nerve roots). Cervical spondylosis Symptoms include cervical instability (abnormal movement or laxity between vertebrae). This instability can lead to various symptoms such as neck pain, muscle imbalance between cervical and shoulder girdle muscles (weakness in cervical flexors, lower trapezius, and anterior serratus; tightness in the upper trapezius, scapular lift, and pectoralis major), disc herniation and osteophyte formation. These can compromise proprioception (accurate sensory feedback) and limit neck mobility, significantly impacting function and daily activities.

Muscle energy techniques is a form of manual therapy frequently used by physical therapists to improve musculoskeletal function and alleviate pain. MET aims to adjust abnormal muscle tone by training specific muscles, enhancing strength and stability, improving the musculoskeletal function, and ultimately improving quality of life.

Another treatment technique is MMT that is now an integral component of many manual physiotherapists' clinical practice. MMT involves sustained passive accessory force/glide to a joint while the participant actively performs a problematic movement.

This study aims to address this gap in knowledge by investigating whether MET or MMT is more effective in improving pain, ROM, proprioception, and functional ability in individuals with cervical spondylosis. The findings from this study can provide valuable insights for physical therapists in selecting the most appropriate treatment approach for their patients with cervical spondylosis. By determining the more effective technique, physical therapists can optimize treatment plans and potentially improve patient outcomes.

This Triple-blinded (the examiner, statistician, and the participants will be blinded, while the therapist will be aware of treatment procedures) randomized controlled trial (RCT) will investigate the effectiveness of Muscle Energy Techniques (MET) compared to Mulligan Mobilization Techniques (MMT) on cervical spine pain, ROM, and function in participants with Cervical Spondylosis (CS). The study will be conducted at the outpatient physical therapy clinic of Horus University in New Damietta, Egypt.

Eligibility criteria: Inclusion Criteria:

1. Participants of both genders aged 40 - 60 years old, diagnosed with clinically and medically stable CS.
2. All participants will be assessed and referred by orthopedic surgeons before starting the study.
3. Mechanical neck pain localized to the cervical.
4. Neck pain lasting more than 3 months, local tenderness of the upper fibers of the trapezius, limitation in cervical ROM and muscle spasm.
5. Moderate pain intensity (45-74 mm on VAS).
6. Participants with Moderate pain intensity NDI (30 - 48%).
7. All participants are free from any pathological conditions that might influence the results.

Exclusion Criteria:

1. Participants with systemic diseases like rheumatoid arthritis, metabolic diseases, or osteoporosis.
2. History of trauma or accidental injuries to the cervical spine.
3. Cervical myelopathy, inflammatory arthritis, tumors, infections involving the cervical spine, or vertebrobasilar artery insufficiency.
4. Cervical spine injury, dizziness, vertigo, or any other musculoskeletal complaints.

Primary outcomes:
measure: Cervical Range of Motion (CROM)
timeFrame: Pre- intervention and after 4 weeks of treatment
measure: The Arabic Version Of Neck Disability Index (NDI).
timeFrame: Pre- intervention and after 4 weeks of treatment
measure: Visual Analogue Scale (VAS).
timeFrame: Pre- intervention and after 4 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New Damittta
country: Egypt
facility: Faculty of Physical Therapy, Horus University - Egypt
Study officials:
References:
citation: Binch AL, Cole AA, Breakwell LM, Michael AL, Chiverton N, Creemers LB, Cross AK, Le Maitre CL. Nerves are more abundant than blood vessels in the degenerate human intervertebral disc. Arthritis Res Ther. 2015 Dec 21;17:370. doi: 10.1186/s13075-015-0889-6.
citation: Manzoor A, Anwar N, Khalid K, Haider R, Saghir M, Javed MA. Comparison of effectiveness of muscle energy technique with Mulligan mobilization in patients with non-specific neck pain. J Pak Med Assoc. 2021 Jun;71(6):1532-1524. doi: 10.47391/JPMA.981.
citation: Atisook R, Euasobhon P, Saengsanon A, Jensen MP. Validity and Utility of Four Pain Intensity Measures for Use in International Research. J Pain Res. 2021 Apr 21;14:1129-1139. doi: 10.2147/JPR.S303305. eCollection 2021.
citation: Audette I, Dumas JP, Cote JN, De Serres SJ. Validity and between-day reliability of the cervical range of motion (CROM) device. J Orthop Sports Phys Ther. 2010 May;40(5):318-23. doi: 10.2519/jospt.2010.3180.
citation: Bagcaci S, Unuvar BS, Gercek H, Ugurlu I, Sert OA, Yilmaz K. A randomized controlled trial on pain, grip strength, and functionality in lateral elbow pain: Mulligan vs muscle energy techniques. J Back Musculoskelet Rehabil. 2023;36(2):419-427. doi: 10.3233/BMR-220061.
citation: Bakhsheshian J, Mehta VA, Liu JC. Current Diagnosis and Management of Cervical Spondylotic Myelopathy. Global Spine J. 2017 Sep;7(6):572-586. doi: 10.1177/2192568217699208. Epub 2017 May 31.
citation: Baron EM, Young WF. Cervical spondylotic myelopathy: a brief review of its pathophysiology, clinical course, and diagnosis. Neurosurgery. 2007 Jan;60(1 Supp1 1):S35-41. doi: 10.1227/01.NEU.0000215383.64386.82.
citation: Binder AI. Cervical spondylosis and neck pain. BMJ. 2007 Mar 10;334(7592):527-31. doi: 10.1136/bmj.39127.608299.80. No abstract available.
citation: Bono CM, Ghiselli G, Gilbert TJ, Kreiner DS, Reitman C, Summers JT, Baisden JL, Easa J, Fernand R, Lamer T, Matz PG, Mazanec DJ, Resnick DK, Shaffer WO, Sharma AK, Timmons RB, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders. Spine J. 2011 Jan;11(1):64-72. doi: 10.1016/j.spinee.2010.10.023.
citation: Brinjikji W, Luetmer PH, Comstock B, Bresnahan BW, Chen LE, Deyo RA, Halabi S, Turner JA, Avins AL, James K, Wald JT, Kallmes DF, Jarvik JG. Systematic literature review of imaging features of spinal degeneration in asymptomatic populations. AJNR Am J Neuroradiol. 2015 Apr;36(4):811-6. doi: 10.3174/ajnr.A4173. Epub 2014 Nov 27.
citation: Buyukturan O, Buyukturan B, Sas S, Kararti C, Ceylan I. The Effect of Mulligan Mobilization Technique in Older Adults with Neck Pain: A Randomized Controlled, Double-Blind Study. Pain Res Manag. 2018 May 15;2018:2856375. doi: 10.1155/2018/2856375. eCollection 2018.
citation: Cheung J, Kajaks T, Macdermid JC. The relationship between neck pain and physical activity. Open Orthop J. 2013 Sep 20;7:521-9. doi: 10.2174/1874325001307010521. eCollection 2013.
citation: Copurgensli C, Gur G, Tunay VB. A comparison of the effects of Mulligan's mobilization and Kinesio taping on pain, range of motion, muscle strength, and neck disability in patients with Cervical Spondylosis: A randomized controlled study. J Back Musculoskelet Rehabil. 2017;30(1):51-62. doi: 10.3233/BMR-160713.
citation: Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
citation: Dong WK, Lin XH. [Clinical observation on cervical spondylosis of neck type treated with acupuncture at original and terminal points of trapezius]. Zhongguo Zhen Jiu. 2012 Mar;32(3):211-4. Chinese.
citation: van Eerd M, Patijn J, Loeffen D, van Kleef M, Wildberger J. The Diagnostic Value of an X-ray-based Scoring System for Degeneration of the Cervical Spine: A Reproducibility and Validation Study. Pain Pract. 2021 Sep;21(7):766-777. doi: 10.1111/papr.13013. Epub 2021 May 18.
citation: Emery SE. Cervical spondylotic myelopathy: diagnosis and treatment. J Am Acad Orthop Surg. 2001 Nov-Dec;9(6):376-88. doi: 10.5435/00124635-200111000-00003.
citation: Exelby L. The Mulligan concept: its application in the management of spinal conditions. Man Ther. 2002 May;7(2):64-70. doi: 10.1054/math.2001.0435.
citation: Ferrara LA. The biomechanics of cervical spondylosis. Adv Orthop. 2012;2012:493605. doi: 10.1155/2012/493605. Epub 2012 Feb 1.
citation: Franke H, Fryer G, Ostelo RW, Kamper SJ. Muscle energy technique for non-specific low-back pain. Cochrane Database Syst Rev. 2015 Feb 27;2015(2):CD009852. doi: 10.1002/14651858.CD009852.pub2.
citation: Ghasemi M, Golabchi K, Mousavi SA, Asadi B, Rezvani M, Shaygannejad V, Salari M. The value of provocative tests in diagnosis of cervical radiculopathy. J Res Med Sci. 2013 Mar;18(Suppl 1):S35-8.
citation: Gillani SN, Ain Q-, Rehman SU, Masood T. Effects of eccentric muscle energy technique versus static stretching exercises in the management of cervical dysfunction in upper cross syndrome: a randomized control trial. J Pak Med Assoc. 2020 Mar;70(3):394-398. doi: 10.5455/JPMA.300417.
citation: Gugliotti M, Tau J, Gallo K, Sagliocca N, Horan M, Sussman N, Wisnewski R. Between-week reliability of the cervical range of motion (CROM) device for upper cervical rotation. J Man Manip Ther. 2021 Jun;29(3):176-180. doi: 10.1080/10669817.2020.1805691. Epub 2020 Aug 18.
citation: Haladaj R, Pingot M, Topol M. The Effectiveness of Cervical Spondylosis Therapy with Saunders Traction Device and High-Intensity Laser Therapy: A Randomized Controlled Trial. Med Sci Monit. 2017 Jan 20;23:335-342. doi: 10.12659/msm.899454.
citation: Hanks J, Myers B. Validity, Reliability, and Efficiency of a Standard Goniometer, Medical Inclinometer, and Builder's Inclinometer. Int J Sports Phys Ther. 2023 Aug 1;18(4):989-996. doi: 10.26603/001c.83944. eCollection 2023.
citation: Hartley KG, Damon BM, Patterson GT, Long JH, Holt GE. MRI techniques: a review and update for the orthopaedic surgeon. J Am Acad Orthop Surg. 2012 Dec;20(12):775-87. doi: 10.5435/JAAOS-20-12-775.
citation: Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
citation: Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.
citation: Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26.
citation: Hussien HM, Abdel-Raoof NA, Kattabei OM, Ahmed HH. Effect of Mulligan Concept Lumbar SNAG on Chronic Nonspecific Low Back Pain. J Chiropr Med. 2017 Jun;16(2):94-102. doi: 10.1016/j.jcm.2017.01.003. Epub 2017 Mar 30.
citation: Jaiswal PR, Qureshi I, Phansopkar PA. Effectiveness of Mulligan's Two-Leg Rotation Versus Muscle Energy Technique in Subjects With Hamstring Tightness. Cureus. 2022 Sep 7;14(9):e28890. doi: 10.7759/cureus.28890. eCollection 2022 Sep.
citation: Kashyap R, Iqbal A, Alghadir AH. Controlled intervention to compare the efficacies of manual pressure release and the muscle energy technique for treating mechanical neck pain due to upper trapezius trigger points. J Pain Res. 2018 Dec 12;11:3151-3160. doi: 10.2147/JPR.S172711. eCollection 2018.
citation: Khan ZK, Ahmed SI, Baig AAM, Farooqui WA. Effect of post-isometric relaxation versus myofascial release therapy on pain, functional disability, rom and qol in the management of non-specific neck pain: a randomized controlled trial. BMC Musculoskelet Disord. 2022 Jun 13;23(1):567. doi: 10.1186/s12891-022-05516-1.
citation: Ptaszkowski K, Slupska L, Paprocka-Borowicz M, Kolcz-Trzesicka A, Zwierzchowski K, Halska U, Przestrzelska M, Mucha D, Rosinczuk J. Comparison of the Short-Term Outcomes after Postisometric Muscle Relaxation or Kinesio Taping Application for Normalization of the Upper Trapezius Muscle Tone and the Pain Relief: A Preliminary Study. Evid Based Complement Alternat Med. 2015;2015:721938. doi: 10.1155/2015/721938. Epub 2015 Aug 12.
citation: Pumberger M, Froemel D, Aichmair A, Hughes AP, Sama AA, Cammisa FP, Girardi FP. Clinical predictors of surgical outcome in cervical spondylotic myelopathy: an analysis of 248 patients. Bone Joint J. 2013 Jul;95-B(7):966-71. doi: 10.1302/0301-620X.95B7.31363.
citation: Razzaq A, Nadeem RD, Akhtar M, Ghazanfar M, Aslam N, Nawaz S. Comparing the effects of muscle energy technique and mulligan mobilization with movements on pain, range of motion, and disability in adhesive capsulitis. J Pak Med Assoc. 2022 Jan;72(1):13-16. doi: 10.47391/JPMA.1360.
citation: Reddy RS, Tedla JS, Dixit S, Abohashrh M. Cervical proprioception and its relationship with neck pain intensity in subjects with cervical spondylosis. BMC Musculoskelet Disord. 2019 Oct 15;20(1):447. doi: 10.1186/s12891-019-2846-z.
citation: Reyhan AC, Sindel D, Dereli EE. The effects of Mulligan's mobilization with movement technique in patients with lateral epicondylitis. J Back Musculoskelet Rehabil. 2020;33(1):99-107. doi: 10.3233/BMR-181135.
citation: Rostron S. The Effects of Massage Therapy on a Patient with Migraines and Cervical Spondylosis: a Case Report. Int J Ther Massage Bodywork. 2021 Sep 2;14(3):15-21. doi: 10.3822/ijtmb.v14i3.629. eCollection 2021 Sep.
citation: Ahmed A, Ibrar M, Arsh A, Wali S, Hayat S, Abass S. Comparing the effectiveness of Mulligan mobilization versus Cyriax approach in the management of patients with subacute lateral epicondylitis. J Pak Med Assoc. 2021 Jan;71(1(A)):12-15. doi: 10.47391/JPMA.186.
citation: Rubinstein SM, Pool JJ, van Tulder MW, Riphagen II, de Vet HC. A systematic review of the diagnostic accuracy of provocative tests of the neck for diagnosing cervical radiculopathy. Eur Spine J. 2007 Mar;16(3):307-19. doi: 10.1007/s00586-006-0225-6. Epub 2006 Sep 30.
citation: Sadeghi A, Rostami M, Ameri S, Karimi Moghaddam A, Karimi Moghaddam Z, Zeraatchi A. Effectiveness of isometric exercises on disability and pain of cervical spondylosis: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2022 Jun 16;14(1):108. doi: 10.1186/s13102-022-00500-7.
citation: Sbardella S, La Russa C, Bernetti A, Mangone M, Guarnera A, Pezzi L, Paoloni M, Agostini F, Santilli V, Saggini R, Paolucci T. Muscle Energy Technique in the Rehabilitative Treatment for Acute and Chronic Non-Specific Neck Pain: A Systematic Review. Healthcare (Basel). 2021 Jun 17;9(6):746. doi: 10.3390/healthcare9060746.
citation: Shaheen AA, Omar MT, Vernon H. Cross-cultural adaptation, reliability, and validity of the Arabic version of neck disability index in patients with neck pain. Spine (Phila Pa 1976). 2013 May 1;38(10):E609-15. doi: 10.1097/BRS.0b013e31828b2d09.
citation: Shedid D, Benzel EC. Cervical spondylosis anatomy: pathophysiology and biomechanics. Neurosurgery. 2007 Jan;60(1 Supp1 1):S7-13. doi: 10.1227/01.NEU.0000215430.86569.C4.
citation: Smith M, Fryer G. A comparison of two muscle energy techniques for increasing flexibility of the hamstring muscle group. J Bodyw Mov Ther. 2008 Oct;12(4):312-7. doi: 10.1016/j.jbmt.2008.06.011. Epub 2008 Aug 6.
citation: Steilen D, Hauser R, Woldin B, Sawyer S. Chronic neck pain: making the connection between capsular ligament laxity and cervical instability. Open Orthop J. 2014 Oct 1;8:326-45. doi: 10.2174/1874325001408010326. eCollection 2014.
citation: Takagi I, Eliyas JK, Stadlan N. Cervical spondylosis: an update on pathophysiology, clinical manifestation, and management strategies. Dis Mon. 2011 Oct;57(10):583-91. doi: 10.1016/j.disamonth.2011.08.024. No abstract available.
citation: Theodore N. Degenerative Cervical Spondylosis. N Engl J Med. 2020 Jul 9;383(2):159-168. doi: 10.1056/NEJMra2003558. No abstract available.
citation: Tu J, Vargas Castillo J, Das A, Diwan AD. Degenerative Cervical Myelopathy: Insights into Its Pathobiology and Molecular Mechanisms. J Clin Med. 2021 Mar 15;10(6):1214. doi: 10.3390/jcm10061214.
citation: Thomas E, Cavallaro AR, Mani D, Bianco A, Palma A. The efficacy of muscle energy techniques in symptomatic and asymptomatic subjects: a systematic review. Chiropr Man Therap. 2019 Aug 27;27:35. doi: 10.1186/s12998-019-0258-7. eCollection 2019.
citation: Uysal SC, Tuzun EH, Eker L, Angin E. Effectiveness of the muscle energy technique on respiratory muscle strength and endurance in patients with fibromyalgia. J Back Musculoskelet Rehabil. 2019;32(3):411-419. doi: 10.3233/BMR-181287.
citation: Venosa M, Romanini E, Padua R, Cerciello S. Comparison of high-intensity laser therapy and combination of ultrasound treatment and transcutaneous nerve stimulation in patients with cervical spondylosis: a randomized controlled trial. Lasers Med Sci. 2019 Jul;34(5):947-953. doi: 10.1007/s10103-018-2682-7. Epub 2018 Nov 15.
citation: Xiong J, Zhang Z, Zhang Z, Ma Y, Li Z, Chen Y, Liu Q, Liao W. Short-term effects of Kinesio taping combined with cervical muscles multi-angle isometric training in patients with cervical spondylosis. BMC Musculoskelet Disord. 2023 Jan 18;24(1):38. doi: 10.1186/s12891-023-06154-x.
citation: Yang J, Lee B, Kim C. Changes in proprioception and pain in patients with neck pain after upper thoracic manipulation. J Phys Ther Sci. 2015 Mar;27(3):795-8. doi: 10.1589/jpts.27.795. Epub 2015 Mar 31.
citation: Young IA, Michener LA, Cleland JA, Aguilera AJ, Snyder AR. Manual therapy, exercise, and traction for patients with cervical radiculopathy: a randomized clinical trial. Phys Ther. 2009 Jul;89(7):632-42. doi: 10.2522/ptj.20080283. Epub 2009 May 21.
citation: Zaidi F, Ahmed I. Effectiveness of muscle energy technique as compared to Maitland mobilisation for the treatment of chronic sacroiliac joint dysfunction. J Pak Med Assoc. 2020 Oct;70(10):1693-1697. doi: 10.5455/JPMA.43722.