Clinical trial NCT04317937: The Effects Of Jaw Sensorimotor System In The Treatment Of Neck Pain And Dysfunction
Official title: The Effects Of Jaw Sensorimotor System In The Treatment Of Neck Pain And Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
PHYSIOTHERAPY
JAW
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be focused on non- specific chronic neck pain patients. The primary objective is to study the effects of jaw sensorimotor system in the treatment of patients with neck pain and dysfunction. It will be randomized controlled trail with the estimated sample size of 80 with both genders. The experimental group will be performed Jaw opening-closing movements with active neck flexion and extension movements and control group will be performed active neck flexion and extension movements. Both groups will be received isometric strengthening exercises, Postural Advice and Home Exercise Program with Dairy. Numeric Pain Rating scale (NPRS), Neck disability Index (NDI), Neck Proprioception tests and Neck muscles endurance test will be used as outcome measures at day 0 and week 6 for treatment effect in both groups. Tables and graphs will used for demographic descriptions and appropriate statistical tests will be applied to establish treatment effect within and between groups.

Detailed description: Study Design : Randomized Controlled Trial

Settings: IPM\&R (Institute of Physical Medicine and Rehabilitation). This institute is a part of Dow University of Health Sciences (Karachi-Pakistan).

Duration of study: 18 months after IRB approval

Sample population: Non-specific chronic neck pain

Sample size calculation Using carried out using PASS Version 11 two sample t test with 95% confidence of interval and 80% power of test, mean of NDI (experimental 16.83± 2.3 and 19.13 ± 2.2) calculated sample size is 16 per group which we have increased up to 40 in each group (Experimental \& Control) including 8 patients as a dropout rate per group (makes at least 32 patients per group).

Sampling technique: Non probability, purposive sampling technique

Inclusion criteria:

* Both genders
* 18 years to 50 years
* Participants with history neck of more than 3 months with no related conditions
* Non radiating pain to arms
* Diagnosed as Nonspecific Chronic Neck pain by consultants
* NPRS-Numeric Pain Rating Scale score 3 to 8
* NDI- Neck Disability Index : score 5 to 34
* No TMJ pain or dysfunction

Exclusion

* NPRS-Numeric Pain Rating Scale Score 1 \& 2 and score 9 \& 10 (Score 1 \& 2 mild pain and Score 9 \& 10 worst pain)
* NDI- Neck Disability Index : Score 0 to 4 (no disability) and score 35 to 50(Complete disability)
* Specific or nonspecific Acute Neck pain (Less than 7 days)
* Neck pain- Specific or nonspecific Sub acute (pain history more than seven days however less than three months)
* Neck pain- Specific Chronic (pain history more than 3 months)
* TMJ Dysfunction
* WAD (Whiplash Associated Disorders)
* Cervical spondylosis
* Rheumatoid arthritis
* Instability of spine
* Facial injury or dental infection
* Any type of infection of body
* Neck or spinal segment fracture
* Spinal tumor or any type of tumor/cancer
* Unexplained headache
* Post cervical spine surgical cases
* Signs and symptoms of Cervical spine stenosis
* Signs and symptoms of disc bulge or herniation of cervical spine
* Radiating neck pain or Radiculopathy of cervical spine
* Cognitive impairment
* Neurological conditions (MS/PD/CVA/MND)
* Application of injection therapy in cervical spine
* Red flags ( Episode of Double vision, Dysarthria, Dysphasia, Drop Attack Dizziness, Double vision, Gait disturbance)

Assessments: After consent filling form, a physiotherapy assessment form will be completed.

Outcome measures (Variables):

i. NPRS ii. NDI iii. Neck Proprioception test iv. Neck Muscles Endurance Test

Treatment assignment (allocation):

In this study, the treatment assignment will be completed using randomization technique.

* In this study, based on inclusion and exclusion criteria, required numbers of sample size participants will recruit first as mentioned earlier using non probability sampling technique.
* Estimated total 80 patients (40 patients per group including dropout rate) (makes at least 32 patients per group) will be selected.
* Total 80 study population will be divided further out in two groups based on gender for giving equal opportunity to participate in this study. 40 male patients (20 for experimental and 20 for control group) and 40 female patients (20 for experimental and 20 for control group) via simple randomization technique using computer generated Microsoft Excel sheet.
* The above mentioned process will be run for male and female parallel or separately depending on the frequency of the patients.

Patients will not be selected in this study based on inclusion criteria, refer to the physiotherapy OPD for assessment and treatment.

Blinding:

* Physiotherapist with minimum two years job experience will be selected and physiotherapist will receive training on how to perform the assessment.
* Treatment blinding will be achieved by asking physiotherapist to complete initial assessment forms with all outcome measures (pre- intervention) to all subjects (referred patients) with non specific chronic neck pain and dysfunction. The physiotherapists will remain unaware about who will be selected as research sample participants including unaware about experimental and control groups.
* At the time of getting consent, patients will be made aware of the relevant details about the research study, however they will remain unaware of their own group allocation.
* The principal investigator alone will administer the treatment.
* The outcome measurements will be taken at day 0 (pre-intervention) and then week 6 outcome measurements (post intervention) will be recorded by physiotherapist.

INTERVENTION: TREATMENT REGIMES FOR EXPERIMENTAL AND CONTROL Experimental group A: Jaw opening-closing movements Active jaw movements Active neck exercises B: Isometric strengthening exercises (Same as control group) C: Postural Advice and Home Exercise Program with Dairy (Same as control group)

Control group:

A: Active neck exercises. B: Isometric strengthening exercises C: Postural Advice and Home Exercise Program with Dairy Postural advice and home exercise program

1. Postural Advise.

   * Maintain upright posture while sitting.
   * Avoid prolonged neck bending.
   * Avoid twisting movement of the neck.
   * Use a suitable pillow to maintain cervical spine.
   * Adjust computer screen at eye level.
   * Avoid constant use of mobile or similar device to prevent excessive strain over neck joints and muscles.
   * Carry light and even weight in both hands while shopping and other chores.
   * Stay hydrated.
2. Home Exercise Program (unsupervised) The following home exercise program will be instructed to all subjects with request to repeat the program 3 times a day.

   * Forward flexion (Self Resisted), 6 sec hold, number of repetitions 15
   * Right side flexion (Self Resisted ), 6 sec hold, number of repetitions 15
   * Left side flexion (Self Resisted) x 6 sec hold,number of repetitions 15
   * Backward flexion (Self Resisted) x 6 sec hold, number of repetitions 15
3. Home Dairy A home dairy will be provided to maintain home exercise program record.

Frequency and Duration of Treatment:

Non-specific Chronic Neck Pain (more than 3 months history of pain) Initial Assessment (week 1) 60 minutes, First treatment session (week1) 40 minutes, 3 treatment sessions per week (week- 2-6 ) 40 minutes, Final Assessment (week 6) 60 minutes.

ETHICAL CONSIDERATIONS

* It will be gained from the Ethical Committee of the University before study
* Written informed consent will be taken from all the patients
* All information and collected data will be kept confidential.
* Participants will remain anonymous throughout the study.
* The Participants will be informed that there are no disadvantages or risks on the procedure of the study.
* Participants will also be informed that they will be free to withdraw at any time during the process of the study.

DATA COLLECTION Data Collection Procedure

* After IRB approval, Data will be collected November 2018 (Subject to approval).
* Collection of data will be initiated once approval of synopsis will be taken.
* Patients will be recruited from IPM\&R and consultants will assess and screen patients as indicated and will pass on to physiotherapy department with diagnosed of non specific chronic pain.
* Initial screening proforma will be completed by a physiotherapist based on inclusion and exclusion criteria.
* Non probability sampling technique will be used for recruitment of patients
* A written consent form will be taken from all participants
* Participants will be divided into two groups (Experimental and control groups) as mentioned above.
* Assessment form including outcome measures will be completed on first visit by a trained physiotherapist with experience in the area field of physiotherapy practice at least 2 years.
* The selected outcome measures will be taken on day 0 (pre intervention), and week 6 (post intervention) will be completed by physiotherapist.
* Treatment will be performed for 6 weeks with postural advice and home exercise program with dairy record by principal investigator.

Eligibility criteria: Inclusion Criteria:

* • Both genders

  * 18 years to 50 years
  * Participants with history neck of more than 3 months with no related conditions
  * Non radiating pain to arms
  * Diagnosed as Nonspecific Chronic Neck pain by consultants
  * NPRS-Numeric Pain Rating Scale: score 3 to 8 (Score 3 Ending of mild pain, Score 8 Beginning of worst pain)
  * NDI- Neck Disability Index: score 5 to 34 (5 to 14 Mild disability,15- 24 Moderate disability \& 25 to 34 Severity disability)
  * No TMJ pain or dysfunction

Exclusion Criteria:

* • NPRS-Numeric Pain Rating Scale: Score 1 \& 2 and score 9 \& 10 (Score 1 \& 2 mild pain and Score 9 \& 10 worst pain)

  * NDI- Neck Disability Index : Score 0 to 4 (no disability) and score 35 to 50(Complete disability)
  * Specific or nonspecific Acute Neck pain (Less than 7 days)
  * Neck pain- Specific or nonspecific Subacute( pain history more than seven days however less than three months)
  * Neck pain- Specific Chronic (pain history more than 3 months)
  * TMJ Dysfunction
  * WAD (Whiplash Associated Disorders)
  * Cervical spondylosis
  * Rheumatoid arthritis
  * Instability of spine
  * Facial injury or dental infection
  * Any type of infection of body
  * Neck or spinal segment fracture
  * Spinal tumor or any type of tumor/cancer
  * Unexplained headache
  * Post cervical spine surgical cases
  * Signs and symptoms of Cervical spine stenosis
  * Signs and symptoms of disc bulge or herniation of cervical spine
  * Radiating neck pain or Radiculopathy of cervical spine
  * Cognitive impairment
  * Neurological conditions (MS/PD/CVA/MND)
  * Application of injection therapy in cervical spine
  * Red flags ( Episode of Double vision, Dysarthria, Dysphasia, Drop Attack, Dizziness, Double vision, Gait disturbance)

Primary outcomes:
measure: Numeric Pain Rating scale (NPRS)
timeFrame: Week 6
measure: Neck disability Index (NDI)
timeFrame: Week 6
measure: Neck Proprioception test
timeFrame: Week 6
measure: Neck muscles endurance test
timeFrame: Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Insititute of Physical Medicine & Rehabilitation
state: Sindh
Study officials:
affiliation: University of Lahore
name: Saeed Akhter, MS
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: Eriksson PO, Haggman-Henrikson B, Nordh E, Zafar H. Co-ordinated mandibular and head-neck movements during rhythmic jaw activities in man. J Dent Res. 2000 Jun;79(6):1378-84. doi: 10.1177/00220345000790060501.
citation: Loeser JD, Treede RD. The Kyoto protocol of IASP Basic Pain Terminology. Pain. 2008 Jul 31;137(3):473-477. doi: 10.1016/j.pain.2008.04.025. Epub 2008 Jun 25. No abstract available.
citation: Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of Pain, Subcommittee on Taxonomy. Pain Suppl. 1986;3:S1-226. No abstract available.
citation: Sihawong R, Janwantanakul P, Sitthipornvorakul E, Pensri P. Exercise therapy for office workers with nonspecific neck pain: a systematic review. J Manipulative Physiol Ther. 2011 Jan;34(1):62-71. doi: 10.1016/j.jmpt.2010.11.005.
citation: Genebra CVDS, Maciel NM, Bento TPF, Simeao SFAP, Vitta A. Prevalence and factors associated with neck pain: a population-based study. Braz J Phys Ther. 2017 Jul-Aug;21(4):274-280. doi: 10.1016/j.bjpt.2017.05.005. Epub 2017 May 20.
citation: Malchaire JB, Roquelaure Y, Cock N, Piette A, Vergracht S, Chiron H. Musculoskeletal complaints, functional capacity, personality and psychosocial factors. Int Arch Occup Environ Health. 2001 Oct;74(8):549-57. doi: 10.1007/s004200100264.
citation: Cimmino MA, Ferrone C, Cutolo M. Epidemiology of chronic musculoskeletal pain. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):173-83. doi: 10.1016/j.berh.2010.01.012.
citation: Vasseljen O, Woodhouse A, Bjorngaard JH, Leivseth L. Natural course of acute neck and low back pain in the general population: the HUNT study. Pain. 2013 Aug;154(8):1237-44. doi: 10.1016/j.pain.2013.03.032. Epub 2013 Apr 2.
citation: Vos CJ, Verhagen AP, Passchier J, Koes BW. Clinical course and prognostic factors in acute neck pain: an inception cohort study in general practice. Pain Med. 2008 Jul-Aug;9(5):572-80. doi: 10.1111/j.1526-4637.2008.00456.x. Epub 2008 Jun 28.
citation: Pernold G, Mortimer M, Wiktorin C, Tornqvist EW, Vingard E; Musculoskeletal Intervention Center-Norrtalje Study Group. Neck/shoulder disorders in a general population. Natural course and influence of physical exercise: a 5-year follow-up. Spine (Phila Pa 1976). 2005 Jul 1;30(13):E363-8. doi: 10.1097/01.brs.0000167819.82642.f7.
citation: Christensen JO, Knardahl S. Time-course of occupational psychological and social factors as predictors of new-onset and persistent neck pain: a three-wave prospective study over 4 years. Pain. 2014 Jul;155(7):1262-1271. doi: 10.1016/j.pain.2014.03.021. Epub 2014 Apr 2.
citation: Carstensen TB. The influence of psychosocial factors on recovery following acute whiplash trauma. Dan Med J. 2012 Dec;59(12):B4560.
citation: Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.
citation: Sharmila B. Isometric muscle energy technique and non-specific neck pain in secondary school teachers-Results of an experimental study.Indian J Physiother Occup Ther. 2014;8(2):58.
citation: Dubner R, Ren K, Sessle BJ. Sensory mechanisms of orofacial pain: Intreatment of TMDs: Bridging the Gap. Pain. 2013;154:511-14.
citation: Avivi-Arber L, Martin R, Lee JC, Sessle BJ. Face sensorimotor cortex and its neuroplasticity related to orofacial sensorimotor functions. Arch Oral Biol. 2011 Dec;56(12):1440-65. doi: 10.1016/j.archoralbio.2011.04.005. Epub 2011 May 8.
citation: McLoon LK, Andrade F. Craniofacial muscles: A new framework for understanding the effector side of craniofacial muscle control. Springer Science & Business Media. 2013:111-30.
citation: Leston JM. [Functional anatomy of the trigeminal nerve]. Neurochirurgie. 2009 Apr;55(2):99-112. doi: 10.1016/j.neuchi.2009.01.001. Epub 2009 Mar 19. French.
citation: De Laat A, Meuleman H, Stevens A, Verbeke G. Correlation between cervical spine and temporomandibular disorders. Clin Oral Investig. 1998 Jun;2(2):54-7. doi: 10.1007/s007840050045.
citation: de Wijer A, Steenks MH, de Leeuw JR, Bosman F, Helders PJ. Symptoms of the cervical spine in temporomandibular and cervical spine disorders. J Oral Rehabil. 1996 Nov;23(11):742-50. doi: 10.1046/j.1365-2842.1996.d01-187.x.
citation: Piovesan EJ, Kowacs PA, Oshinsky ML. Convergence of cervical and trigeminal sensory afferents. Curr Pain Headache Rep. 2003 Oct;7(5):377-83. doi: 10.1007/s11916-003-0037-x.
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: Bruflat AK, Balter JE, McGuire D, Fethke NB, Maluf KS. Stress management as an adjunct to physical therapy for chronic neck pain. Phys Ther. 2012 Oct;92(10):1348-59. doi: 10.2522/ptj.20110489. Epub 2012 Jun 14.
citation: Cote P, van der Velde G, Cassidy JD, Carroll LJ, Hogg-Johnson S, Holm LW, Carragee EJ, Haldeman S, Nordin M, Hurwitz EL, Guzman J, Peloso PM. The burden and determinants of neck pain in workers: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S70-86. doi: 10.1016/j.jmpt.2008.11.012.
citation: Chiu TW, Leung SL, Lam KW. Neck pain in Hong Kong: a telephone survey on consequences and health service utilisation. Hong Kong Med J. 2012 Aug;18 Suppl 3:13-5. No abstract available.
citation: Skillgate E, Magnusson C, Lundberg M, Hallqvist J. The age- and sex-specific occurrence of bothersome neck pain in the general population--results from the Stockholm public health cohort. BMC Musculoskelet Disord. 2012 Sep 24;13:185. doi: 10.1186/1471-2474-13-185.
citation: Falco FJ, Manchikanti L, Datta S, Wargo BW, Geffert S, Bryce DA, Atluri S, Singh V, Benyamin RM, Sehgal N, Ward SP, Helm S 2nd, Gupta S, Boswell MV. Systematic review of the therapeutic effectiveness of cervical facet joint interventions: an update. Pain Physician. 2012 Nov-Dec;15(6):E839-68.
citation: Lauche R, Cramer H, Langhorst J, Dobos G, Gerdle B. Neck pain intensity does not predict pressure pain hyperalgesia: re-analysis of seven randomized controlled trials. J Rehabil Med. 2014 Jun;46(6):553-60. doi: 10.2340/16501977-1815.
citation: Martel J, Dugas C, Dubois JD, Descarreaux M. A randomised controlled trial of preventive spinal manipulation with and without a home exercise program for patients with chronic neck pain. BMC Musculoskelet Disord. 2011 Feb 8;12:41. doi: 10.1186/1471-2474-12-41.
citation: Hoy DG, Protani M, De R, Buchbinder R. The epidemiology of neck pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):783-92. doi: 10.1016/j.berh.2011.01.019.
citation: Sowmya MV. Isometric neck exercises versus dynamic neck exercises in chronic neck pain. 2014;3(2):32-43
citation: Pillastrini P, de Lima E Sa Resende F, Banchelli F, Burioli A, Di Ciaccio E, Guccione AA, Villafane JH, Vanti C. Effectiveness of Global Postural Re-education in Patients With Chronic Nonspecific Neck Pain: Randomized Controlled Trial. Phys Ther. 2016 Sep;96(9):1408-16. doi: 10.2522/ptj.20150501. Epub 2016 Mar 24.
citation: Beltran-Alacreu H, Lopez-de-Uralde-Villanueva I, Fernandez-Carnero J, La Touche R. Manual Therapy, Therapeutic Patient Education, and Therapeutic Exercise, an Effective Multimodal Treatment of Nonspecific Chronic Neck Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2015 Oct;94(10 Suppl 1):887-97. doi: 10.1097/PHM.0000000000000293.
citation: Pöntinen PJ. Reliability, validity, reproducibility of algometry in diagnosis of active and latent tender spots and trigger points. J Musculoskelet Pain. 1998;6(1):61-71.
citation: Fischer AA. Pressure algometry over normal muscles. Standard values, validity and reproducibility of pressure threshold. Pain. 1987 Jul;30(1):115-126. doi: 10.1016/0304-3959(87)90089-3.
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: Salo P, Ylinen J, Kautiainen H, Arkela-Kautiainen M, Hakkinen A. Reliability and validity of the finnish version of the neck disability index and the modified neck pain and disability scale. Spine (Phila Pa 1976). 2010 Mar 1;35(5):552-6. doi: 10.1097/BRS.0b013e3181b327ff.
citation: Hallgren RC, Andary MT. Undershooting of a neutral reference position by asymptomatic subjects after cervical motion in the sagittal plane. J Manipulative Physiol Ther. 2008 Sep;31(7):547-52. doi: 10.1016/j.jmpt.2008.08.011.
citation: Rheault W, Albright B, Beyers C, Franta M, Johnson A, Skowronek M, Dougherty J. Intertester reliability of the cervical range of motion device. J Orthop Sports Phys Ther. 1992;15(3):147-50. doi: 10.2519/jospt.1992.15.3.147.
citation: Youdas JW, Carey JR, Garrett TR. Reliability of measurements of cervical spine range of motion--comparison of three methods. Phys Ther. 1991 Feb;71(2):98-104; discussion 105-6. doi: 10.1093/ptj/71.2.98.
citation: Harris KD, Heer DM, Roy TC, Santos DM, Whitman JM, Wainner RS. Reliability of a measurement of neck flexor muscle endurance. Phys Ther. 2005 Dec;85(12):1349-55.
citation: Sebastian D, Chovvath R, Malladi R. Cervical extensor endurance test: a reliability study. J Bodyw Mov Ther. 2015 Apr;19(2):213-6. doi: 10.1016/j.jbmt.2014.04.014. Epub 2014 Apr 18.
citation: Akhter S, Khan M, Ali SS, Soomro RR. Role of manual therapy with exercise regime versus exercise regime alone in the management of non-specific chronic neck pain. Pak J Pharm Sci. 2014 Nov;27(6 Suppl):2125-8.
citation: Zar JH. Biostatistical Analysis. 4th ed. New Jersey: Pearson; 2010.
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: Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.