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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05044078
Other study ID # MSiddiqi
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 28, 2021
Est. completion date December 31, 2021

Study information

Verified date February 2022
Source Dow University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this randomized control trial is to determine the effectiveness of Autogenic and Reciprocal Inhibition techniques with conventional therapy in mechanical neck pain to improve Pain, Range of Motion, and Functional Disability in long term. This study is being conducted at the Physiotherapy department of Sindh Institute of Physical Medicine and Rehabilitation, Karachi (former institute of Dow University of Health Sciences) among 80 patients with mechanical neck pain on the basis of non-probability purposive sample technique with screening for study criteria through a consultant physician (blinded) . After taking informed consent all participants will be randomly allocated in two groups through second researcher who is not involved in screening, baseline assessment and providing intervention. Group 1 will receive Autogenic Inhibition muscle energy technique (MET) with conventional therapy and Group 2 will receive Reciprocal inhibition MET with conventional therapy. A total of 12 sessions will be provided. Outcomes will be assessed at baseline, after 1st session, and at last session.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Moderate intensity (3.5-7.4cm) Pain on VAS - Limited or Painful Cervical ROM - Pain more than 4 weeks (sub-acute and chronic) - 20-50 years Age Exclusion Criteria: - Any Symptom and sign of Radiculopathy and Myelopathy - Any neurological disease like Multiple Sclerosis, Parkinson or Stroke - Taking any Pain medication - Trigger Point of Upper Trapezius - Any fracture, surgical procedure, or trauma of the cervical spine - Any red flag or signs of serious pathology like rheumatic or inflammatory diseases, malignancy, infection, or vascular disease such as Vertebro-Basilar Insufficiency.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Autogenic Inhibition MET
If a sub-maximal contraction of the muscle is followed by stretching of the same muscle it is known as Autogenic Inhibition MET.
Reciprocal Inhibition MET
If a submaximal contraction of a muscle is followed by stretching of the opposite muscle then this is known as Reciprocal Inhibition MET.

Locations

Country Name City State
Pakistan Sindh Institue of Physical Medicine and Rehabilitation Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

References & Publications (31)

Ackelman BH, Lindgren U. Validity and reliability of a modified version of the neck disability index. J Rehabil Med. 2002 Nov;34(6):284-7. — View Citation

Binder AI. Cervical spondylosis and neck pain. BMJ. 2007 Mar 10;334(7592):527-31. Review. — View Citation

Binder AI. Neck pain. BMJ Clin Evid. 2008 Aug 4;2008. pii: 1103. Review. — View Citation

Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302. — View Citation

Boonstra AM, Schiphorst Preuper HR, Balk GA, Stewart RE. Cut-off points for mild, moderate, and severe pain on the visual analogue scale for pain in patients with chronic musculoskeletal pain. Pain. 2014 Dec;155(12):2545-2550. doi: 10.1016/j.pain.2014.09.014. Epub 2014 Sep 17. — View Citation

Branco. Cervical Range of Motion and Isometrics [Internet]. Prpaspinesurgery.com. [cited 2021 Apr 4]. Available from: https://www.prpaspinesurgery.com/wpcontent/uploads/Isometrics-cervical.pdf.

Cervical Spine Goniometry [Internet]. Uwa.edu. [cited 2021 Apr 2]. Available from: http://at.uwa.edu/gon/cspine.htm

Elsevier. Muscle Energy Techniques E-Book [Internet]. Elsevier.com. [cited 2021 Apr 2]. Available from: https://www.elsevier.com/books/muscle-energy-techniques-with-dvdrom/chaitow/978-0-7020-3243-1.

Evans G. Identifying and treating the causes of neck pain. Med Clin North Am. 2014 May;98(3):645-61. doi: 10.1016/j.mcna.2014.01.015. Epub 2014 Mar 22. Review. — View Citation

Farooq MN, Mohseni-Bandpei MA, Gilani SA, Hafeez A. Urdu version of the neck disability index: a reliability and validity study. BMC Musculoskelet Disord. 2017 Apr 8;18(1):149. doi: 10.1186/s12891-017-1469-5. — View Citation

Gandbhir VN, Cunha B. Goniometer. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2020

Gross A, Kay TM, Paquin JP, Blanchette S, Lalonde P, Christie T, Dupont G, Graham N, Burnie SJ, Gelley G, Goldsmith CH, Forget M, Hoving JL, Brønfort G, Santaguida PL; Cervical Overview Group. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2015 Jan 28;1:CD004250. doi: 10.1002/14651858.CD004250.pub5. Review. — View Citation

Gross AR, Kay T, Hondras M, Goldsmith C, Haines T, Peloso P, Kennedy C, Hoving J. Manual therapy for mechanical neck disorders: a systematic review. Man Ther. 2002 Aug;7(3):131-49. Review. — View Citation

Heintz MM, Hegedus EJ. Multimodal management of mechanical neck pain using a treatment based classification system. J Man Manip Ther. 2008;16(4):217-24. — View Citation

Howell ER. The association between neck pain, the Neck Disability Index and cervical ranges of motion: a narrative review. J Can Chiropr Assoc. 2011 Sep;55(3):211-21. — View Citation

Hoy D, March L, Woolf A, Blyth F, Brooks P, Smith E, Vos T, Barendregt J, Blore J, Murray C, Burstein R, Buchbinder R. The global burden of neck pain: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1309-15. doi: 10.1136/annrheumdis-2013-204431. Epub 2014 Jan 30. — View Citation

Jalal Y, Ahmad A, Rahman AU; Irfanullah, Daud M; Aneela. Effectiveness of muscle energy technique on cervical range of motion and pain. J Pak Med Assoc. 2018 May;68(5):811-813. — View Citation

Kahl C, Cleland JA. Visual analogue scale, numeric pain rating scale and the McGill pain Questionnaire: an overview of psychometric properties. Phys Ther Rev. 2005;10(2):123-8

Karnath BM. Identifying the musculoskeletal causes of neck pain [Internet]. Rheumatologynethreefiverk.com. [cited 2021 Apr 2]. Available from: https://www.rheumatologynetwork.com/view/identifying-musculoskeletal-causes-neck-pain

MacDermid JC, Walton DM, Avery S, Blanchard A, Etruw E, McAlpine C, Goldsmith CH. Measurement properties of the neck disability index: a systematic review. J Orthop Sports Phys Ther. 2009 May;39(5):400-17. doi: 10.2519/jospt.2009.2930. Review. — View Citation

Miller J, Gross A, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Brønfort G, Hoving JL. Manual therapy and exercise for neck pain: a systematic review. Man Ther. 2010 Aug;15(4):334-54. Review. — View Citation

Osama M, Shakil Ur Rehman S. Effects of static stretching as compared to autogenic inhibition and reciprocal inhibition muscle energy techniques in the management of mechanical neck pain: a randomized controlled trial. J Pak Med Assoc. 2020 May;70(5):786-790. doi: 10.5455/JPMA.9596. — View Citation

Osama M, Tassadaq N, Malik RJ. Effect of muscle energy techniques and facet joint mobilization on spinal curvature in patients with mechanical neck pain: A pilot study. J Pak Med Assoc. 2020 Feb;70(2):344-347. doi: 10.5455/JPMA.14189. — View Citation

Phadke A, Bedekar N, Shyam A, Sancheti P. Effect of muscle energy technique and static stretching on pain and functional disability in patients with mechanical neck pain: A randomized controlled trial. Hong Kong Physiother J. 2016 Apr 14;35:5-11. doi: 10.1016/j.hkpj.2015.12.002. eCollection 2016 Dec. — View Citation

Safiri S, Kolahi AA, Hoy D, Buchbinder R, Mansournia MA, Bettampadi D, Ashrafi-Asgarabad A, Almasi-Hashiani A, Smith E, Sepidarkish M, Cross M, Qorbani M, Moradi-Lakeh M, Woolf AD, March L, Collins G, Ferreira ML. Global, regional, and national burden of neck pain in the general population, 1990-2017: systematic analysis of the Global Burden of Disease Study 2017. BMJ. 2020 Mar 26;368:m791. doi: 10.1136/bmj.m791. — View Citation

Satria Nugraha MH, Antari NKAJ, Saraswati NLPGK. The efficacy of muscle energy technique in individuals with mechanical neck pain: A systematic review. Sport Fit J. 2020;8(2):91.

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. — View Citation

Waxenbaum JA, Lu M. Physiology, Muscle Energy. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2020.

What can you do about non-specific neck pain? Institute for Quality and Efficiency in Health Care (IQWiG); 2019.

Yadav H. Efficacy of Muscle Energy Technique and Deep Neck Flexors Training in Mechanical Neck Pain: A Randomized Clinical trial. Int J Ther Rehabil. 2014;4(1).

Young BA, Walker MJ, Strunce JB, Boyles RE, Whitman JM, Childs JD. Responsiveness of the Neck Disability Index in patients with mechanical neck disorders. Spine J. 2009 Oct;9(10):802-8. doi: 10.1016/j.spinee.2009.06.002. Epub 2009 Jul 25. — View Citation

* Note: There are 31 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in pain on the 10 centimetre Visual analogue scale (VAS-10cm) at first day. The patient will asked to mark the pain Intensity on the line of 0-10cm that measures the level of pain. The 0 refers no pain and 10-cm refers excruciating pain as perceived as maximum. Baseline and 1 day
Primary Change from baseline in pain on the 10 centimetre Visual analogue scale (VAS-10cm) at 12 session. The patient will asked to mark the pain Intensity on the line of 0-10cm that measures the level of pain. The 0 refers no pain and 10-cm refers excruciating pain as perceived as maximum Baseline and 3 weeks
Primary Change from baseline in disability on the Neck Disability Index (NDI) at first session. This questionnaire has been designed to give information as to neck pain of patient has affected the ability to manage in everyday life. Patient will be asked to answer every section and mark in each section only the one box that most closely describes his or her problem. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points summed to a total score.The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. The 0 points or 0% means : no activity limitations, 50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability. It is available in both English and Urdu. Minimum Detectable Change (90% confidence): 5 points or 10% points. Baseline and 1 day
Primary Change from baseline in disability on the Neck Disability Index (NDI) at 12 sessions. This questionnaire has been designed to give information as to neck pain of patient has affected the ability to manage in everyday life. Patient will be asked to answer every section and mark in each section only the one box that most closely describes his or her problem. The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. Points summed to a total score.The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage. The 0 points or 0% means : no activity limitations, 50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability. It is available in both English and Urdu. Minimum Detectable Change (90% confidence): 5 points or 10% points. Baseline and 3 weeks
Primary Change from baseline in Neck range of motion measured through Goniometer at first session. It is an instrument that is used to measures the available Range of Motion around a joint in degrees. The investigator will appropriately place goniometer to measure the range of motions of neck (Flexion, extension, right and left lateral flexion and rotation). Lower the reading of goniometer suggests decreased in range of motion and vice versa. Baseline and 1 day
Primary Change from baseline in Neck range of motion measured through Goniometer at 12 session. It is an instrument that is used to measures the available Range of Motion around a joint in degrees. The investigator will appropriately place goniometer to measure the range of motions of neck (Flexion, extension, right and left lateral flexion and rotation). Lower the reading of goniometer suggests decreased in range of motion and vice versa. Baseline and 3 weeks
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