Clinical trial NCT05044078: Effects of Autogenic and Reciprocal Inhibition Techniques With Conventional Therapy in Mechanical Neck Pain
Official title: Effects of Autogenic and Reciprocal Inhibition Techniques With Conventional Therapy in Mechanical Neck Pain- A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Neck Pain
Keywords: Neck Pain
Manual Therapies
Therapy-Soft Tissue
Muscle Stretching exercises
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a randomized control trial. Total 80 patients will be recruited, 40 in each group that includes 10 patients as a dropout in both groups. There will be one interventional group and one active comparator group. Treatment will be allocated using a random number sheet generated by statistician. Participants are assigned to one of two groups in parallel for the duration of the study.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in pain on the 10 centimetre Visual analogue scale (VAS-10cm) at first day.
timeFrame: Baseline and 1 day
measure: Change from baseline in pain on the 10 centimetre Visual analogue scale (VAS-10cm) at 12 session.
timeFrame: Baseline and 3 weeks
measure: Change from baseline in disability on the Neck Disability Index (NDI) at first session.
timeFrame: Baseline and 1 day
measure: Change from baseline in disability on the Neck Disability Index (NDI) at 12 sessions.
timeFrame: Baseline and 3 weeks
measure: Change from baseline in Neck range of motion measured through Goniometer at first session.
timeFrame: Baseline and 1 day
measure: Change from baseline in Neck range of motion measured through Goniometer at 12 session.
timeFrame: Baseline and 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Sindh Institue of Physical Medicine and Rehabilitation
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Mahrukh Siddiqi, MSAPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Sindh Institute of Physical Medicine and Rehabilitation, Karachi, Pakistan
name: Saeed Akhter, MSPT
role: STUDY_DIRECTOR
affiliation: Sindh Institute of Physical Medicine and Rehabilitation, Karachi, Pakistan.
name: Aftab Ahmed Mirza Baig, MSAPT
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Binder AI. Neck pain. BMJ Clin Evid. 2008 Aug 4;2008:1103.
citation: 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.
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. doi: 10.1179/106698108790818260.
citation: 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
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: Miller J, Gross A, D'Sylva J, Burnie SJ, Goldsmith CH, Graham N, Haines T, Bronfort G, Hoving JL. Manual therapy and exercise for neck pain: a systematic review. Man Ther. 2010 Aug;15(4):334-54.
citation: 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, Bronfort G, Santaguida PL; Cervical Overview Group. Exercises for mechanical neck disorders. Cochrane Database Syst Rev. 2015 Jan 28;1(1):CD004250. doi: 10.1002/14651858.CD004250.pub5.
citation: What can you do about non-specific neck pain? Institute for Quality and Efficiency in Health Care (IQWiG); 2019.
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.
citation: Waxenbaum JA, Woo MJ, Lu M. Physiology, Muscle Energy. 2024 Jan 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559029/
citation: 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.
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.
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.
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.
citation: Gandbhir VN, Cunha B. Goniometer. 2020 Jun 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK558985/
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
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: 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. doi: 10.1054/math.2002.0465.
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.
citation: 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).
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.
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.
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.
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.
citation: Cervical Spine Goniometry [Internet]. Uwa.edu. [cited 2021 Apr 2]. Available from: http://at.uwa.edu/gon/cspine.htm
citation: 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.
citation: 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. doi: 10.1080/165019702760390383.
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.
citation: 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.
citation: Siddiqui M, Akhter S, Baig AAM. Effects of autogenic and reciprocal inhibition techniques with conventional therapy in mechanical neck pain - a randomized control trial. BMC Musculoskelet Disord. 2022 Jul 25;23(1):704. doi: 10.1186/s12891-022-05668-0.