Manual Therapy Versus Therapeutic Exercise in non-specific chronic neck pain: study protocol for a randomized controlled trial.

doi:10.21203/rs.2.467/v1

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Manual Therapy Versus Therapeutic Exercise in non-specific chronic neck pain: study protocol for a randomized controlled trial.

https://doi.org/10.21203/rs.2.467/v1

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• Background: The underlying mechanisms that are causes of non-specific chronic neck pain relapses are not clear, but it could be associated with a deficit and alteration of the proprioception of the neck muscles that play a decisive role in the cervical joint position, motor control of the head and about postural stability. Numerous treatments for non-specific chronic neck pain have been described in the scientific literature. However, few studies analyze its influence on postural stability, since these alterations are not fully described, and various theories emerge about the reasons that cause it. Our mainly aim is analyze the differences in postural stability, pain, cervical disability and the relation between them produced by a treatment based on manual therapy and another based on therapeutic exercise. • Methods: The short-term and mid-term changes produced by different therapies on subjects with non-specific chronic neck pain will be studied. The sample will be randomly divided into three groups, manual therapy, therapeutic exercise and placebo. The general stability index, measured through a dynamic stabilometric platform, pain based on the visual analog scale and the pressure pain threshold, and the cervical disability through the cervical disability index were taken as dependent variables of the study. The findings will be analyzed statistically considering a 5% significance level (p ≤ 0.05) • Discussion: Our study aims to provide knowledge about postural stability and its relationship with pain in subjects with non-specific chronic neck pain. Analyzing the results produced by different types of therapy will allow us to draw conclusions about the mechanisms that provoke these alterations, structural or central mechanisms. • Trial registration: Brazilian Clinical Trial Registry, RBR-2vj7sw. Registered on 28 November 2018.

General Medicine

Neck Pain

Chronic Pain

Exercise Therapy

Musculoskeletal Manipulations

Postural Stability

Physical Therapy Specialty

Nonspecific neck pain is pain that does not show pathognomonic signs and symptoms, [1] when the duration of symptoms is greater than 12 weeks of evolution, it acquires the value of chronicity, being denominated non-specific chronic neck pain (NCNP). [2] It is a common disorder, which generates a great impact and socio-economic cost. [3]

The underlying mechanisms that are causes of NCNP relapses are not clear, but it could be associated with a deficit and alteration of the proprioception of the neck muscles that play a decisive role in the cervical joint position, motor control of the head and muscles. eyes, and about postural stability (PS). [4]

Patients with NCNP usually have alterations in cervical proprioception and PS. May develop symptoms such as dizziness or vertigo. [5]

Numerous studies downplay the efficacy of manual therapy and therapeutic exercise for pain reduction, cervical disability and associated symptoms, such as dizziness. [6-8] However, there is less evidence of how these treatments, common in the clinical practice, influence to PS. [9]

PE is highly influenced by the upper cervical spine and the suboccipital muscles, which is composed of up to 200 neuromuscular spindles per gram of muscle. [10, 11] This upper cervical segment is connected to the central nervous system (CNS), the visual apparatus and vestibular and the sympathetic nervous system. [12-15] In addition to cervical afferents through the cervico-ocular reflex (COR), the cervico-colic reflex (CCR) and the tonic neck reflex (TNR), which are also involved; the CCR activates the cervical musculature in response to stretching, maintaining good head position. [16] COR through the vestibular reflex and the optokinetic reflex. [17] The TNR added to the vestibulospinal reflex achieves the maintenance of the PS. [18]

The alteration of this proprioceptive complex is not completely defined. Various theories arise that it can influence the system. Some studies indicate that there is a proprioceptive alteration due to sustained exposure to pain that affects PS through the CNS, these changes may be due to changes in the cortical representation and modulation of the cervical afferent contribution. [19, 20]

However, others relate the loss of PS to the dysfunction of the upper cervical spine and its musculature, changes in the cervical mechanoreceptors and the state of weakness of the musculature. [21-23] If many not have to be, necessarily associated with traumatic events, since this type of alterations have been identified among subjects with NCNP without exposure to trauma. [23]

Primary Objetive

The aim of our study is to compare two scientifically approved therapies for the NCNP, one of them with a greater influence on the structural component, and the other one, with a greater component on the central process, to observe differences in the PS of the subjects with NCNP.

Secundary Objetive

Analyze the evolution of cervical pain and disability according to the treatment applied.

Trial Design:

Randomized, controlled, parallel, double-blind, three-arm clinical trial of treatment.

Sample Selection

Individuals with NCNP will be recruited through a text message broadcast on social networks in the city of Seville (Spain) and will be selected based on the eligibility criteria listed below. The study will take place in the facilities of the physiotherapy department of the University of Seville

Inclusion criteria

· Age 18–65 years

· Current neck pain

· Neck pain continued for at least the last twelve weeks. [2]

Exclusion criteria

· Irradiated neck pain

· Neck pain associated with dizziness

· Osteoporosis

· Psychological disorders

· Vertebral fractures

· Tumors Metabolic diseases

· Previous neck surgery

· Red Flags (Night pain, severe muscle spasm, loss of involuntary weight, symptom mismatch)

· Physiotherapeutic treatment continued in the last three months

Interventions

The participants can only receive the assigned treatment, when they do not combine the treatment with drugs or other physiotherapeutic treatment. Any interference in the treatment will be grounds for exclusion.

Group 1: Manual Therapy

"Manual Therapy" protocol will be composed of three techniques based on scientific evidence.

This protocol will be applied in the three treatment sessions, one per week.

1. High Thoracic Manipulation on T4. [24]

2. Cervical Articular Mobilization (2 Hz, 2 minutes x 3 series). [25]

3. Suboccipital Inhibition (3 minutes). [26]

Group 2: Therapeutic Exercise

"Therapeutic Exercise" protocol: this protocol will be taught to patients in the first session and should be done once a day during the three weeks of treatment. It will be reinforced by the physiotherapist in each of the three individual sessions.

WEEK 1: Exercises 1 and 2.

1. Cranio-cervical flexion (CCF) in supine position with towel in the posterior area of the neck. (3 sets, 10 repetitions, 10 seconds of contraction each repetition with 10 seconds of rest).

2. CCF sitting. (3 sets, 10 repetitions, 10 seconds of contraction each repetition with 10 seconds of rest)

WEEK 2: Exercises 1, 2, 3 and 4.

3. Co-contraction of deep and superficial neck flexors in supine decubitus. (10 repetitions, 10 seconds of contraction with 10 seconds of rest).

4. Co-contraction flexors, rotators and inclines. Patients will perfomed cranial nerve flexion, while physiotherapist ask him to tilt, rotate and look towards the same side while he opposes a resistance with his hand. (10 repetitions, 10 seconds of contraction with 10 seconds of rest).

WEEK 3: Exercises 1, 2, 3, 4, 5 and 6.

5. Eccentric for extenders. With the patient seated, neutral position. Perform cervical extension, for the cranial-cervical flexion and then for cervical flexion. (10 repetitions).

6. Eccentric for flexors. The patient will be in quadrupedal and neutral neck position. Going to the neck flexion, then the cranio-cervical flexion, and maintaining that posture extend the neck and then finally lose the cranial-cervical flexion. (10 repetitions).

Group 3: Sham Treatment

"Control" protocol: Patients will be placed in the supine position, while the physiotherapist will lay his hands without therapeutic intention on the patient's neck for three minutes, later by a means of a laser pointer off, they will be contacted without exerting pressure for 10 seconds.

Outcomes Measures

· Neck Disability Index (NDI). The NDI is a self-assessment instrument of the specific functional status of subjects with neck pain with 10 elements that include pain, personal care, weight gain, reading, headache, concentration, work, driving, sleeping, and leisure. Each section is rated on a scale of 0 to 5, where 0 means "painless" and 5 means "the worst pain imaginable." The points obtained are added to a total score. The questionnaire was interpreted as a percentage. The disability categories for NDI are 0% -8%, without disability; 10% -28%, mild; 30% -48%, moderate; 50% -64%, serious; and 70% -100%, complete. [27, 28]

· Visual Analog Scale (VAS) for pain. The subjects participating in the study indicated the intensity of their pain by means of the EVA of 100mm, they had to signal in a horizontal line of 100mm where they would place their pain, being 0mm "no pain" and the 100mm would be "the worst pain imaginable". [29]

· Pressure Pain Threshold (PPT). The PPT was recorded in Newton / cm2 using digital algometer (Force Ten ™ -Model FDX, Wagner, Greenwich-USA) with a surface area of round tip of 1cm2. The measurement was taken on the spinous process of vertebra C2, the evaluator gradually and gradually increasing the pressure until the patient indicated through a "Yes" when the pain or discomfort appeared. Three measurements were made, obtaining an average value of these three measurements for the statistical analysis. [30, 31]

· Overall Balance Index (OBI). We obtained this measurement through a dynamic stabilometric platform (Balance System ™ SD, Biodex, New York-USA). The General Stability Test was applied in level of difficulty 4, with 1 being the highest and 8 the least difficulty. The platform is free in the anterior-posterior and medial-lateral axes, it allows obtaining the OBI through the deviations with respect to a zero point established before the test, with the platform stable. Two 20-second tests were performed, with one minute between each test, with the score of the second test that was chosen for the statistical analysis. [32, 33]

These variables will be measured in the pre-evaluation, first evaluation (week 2), second evaluation (week 4, short-term) and third evaluation (week 12, medium term). These evaluations will be carried out by an evaluator trained in them, the data will be stored in an excel document.

Participants’ timeline

A brief Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) flow diagram is provided in Fig. 1, and a populated SPIRIT checklist is provided in Additional file 1.

	STUDY PERIOD
	Enrolment	Allocation	Post-allocation (treatment)	Follow-Up (evaluations)
TIMEPOINT	*0 Week*	1 week	*1 Week*	*2 Week*	*3 Week*	*2 Week*	4 *Week*	12 *Week*
ENROLMENT:
Eligibility screen	X
Informed consent	X
*Clinical Evaluation and Inclusion -Exclusion Criteria*	X
Allocation		X
INTERVENTIONS:
*Manual Therapy Protocol*			X	X	X
*Therapeutic Exercise Protocol*			X	X	X
*Sham Protocol*			X	X	X
ASSESSMENTS:
*Demographic Data*	X
*Neck Disability Index*						X	X	X
*Visual Analog Scale*						X	X	X
*Pressure Pain Threshold*						X	X	X
*Overall Balance Index*						X	X	X

Sample Size Calculation

The sample size was calculated using the Granmo calculator v.7.12, based on the analysis of the variance of means, and estimating an alpha risk of 5% (0.05), a beta risk of 10% (0.10), in a unilateral contrast, a typical deviation of 12% (0.12), a minimum difference to detect of 13.5% (0.135) which is based as the minimum clinically important differences in VAS [34], and a rate of follow-up losses of 8%, for which 20 subjects are required in each group, assuming that there are three groups. Finally, we will include 66 patients who will be divided into three groups, each group of at least 20 subjects, being able to overcome this value to assume the possible loss of follow-up.

Randomization

Subjects will be divided into three groups by means of balanced randomization, carried out with free software (http://www.randomized.com/). The randomization sequence will only be done by the principal investigator and auditor.

Blinding

Evaluator and participants in the study will be blinded during the entire process.

Stadistical Analysis

The statistical analysis will be carried out through the IBM-SPSS Statistics 24 software. The normality test applied to all the variables will be the Kolmogorov-Smirnov test. For the contrast of intragroup hypotheses, Student's T test for paired variables will be applied in the case of parametric distributions and Kruskal-Wallis H for non-parametric distributions. For the intergroup hypothesis contrast, one factor ANOVA will be used in the case of parametric distributions and Kruskal-Wallis H for nonparametric distributions. Post-Hoc analysis will be obtained through Bonferroni's contrast for parametric distributions and Mann-Whitney's U for nonparametric ones. The confidence level used will be 95% (0'05) and the power of the study will be 90% (0'1).

This article presents a detailed description of a randomized controlled trial designed to analyze the results in terms of pain, disability and postural stability of two types of treatments for non-specific chronic neck pain.

We intend to investigate a little-studied field such as postural stability in these subjects, and try to understand the mechanisms that produce these alterations. We propose two types of treatments, one using manual therapy based on the structural influences of the neck and another based on the therapeutic exercise that exerts its effect through more neurophysiological mechanisms. Observing the effects of these two therapies we will try to analyze to gain a better understanding the mechanisms that cause postural instability in this type of subjects. Our results intend to present whether the provocative mechanisms have a more structural component, or instead, are caused by alterations produced at the level of the central nervous system by the sustained exposure of this to pain.

We have designed a randomized, controlled, double-blinded clinical trial, with the aim that our study could contribute to increase scientific knowledge on this matter, and could initiate new lines of future research.

This is the first and definitive protocol versión. Participants will be recruited between January-March 2019. Study completion is expected to be July 2019.

NCNP: Non-Specifik Chronic Neck Pain

PS: Postural Stability

CCF: Cranio-Cervical Flexion

NDI: Neck Disability Index

VAS: Visual Analog Scale

PPT: Pressure Pain Threshold

OBI: Overall Balance Index

Ethics approval and consent to participate

This study complies with the Helsinki guidelines for human research and it has been approved by the ethics committee of the University Hospital Virgen Macarena – Virgen del Rocío. The identification of each individual will remain concealed based on the ethical principles of confidentiality and privacy. All participants will receive an informed consent that they will approve for participation in the study.

Consent for publication

Not applicable.

Availability of data and material

Not applicable.

Competing interests

The autors declare that they have not competing interests.

Funding

This trial was conducted with no external funding and its costs have been assumed by researchers.

Authors' contributions

CRB is the director of the proyect, contributed to the protocol development, provided clinical expertise and he is responsible for designing statistical procedures. JJGG is the co-director of the proyect and contributed to the protocol development and provided clinical expertise. MSH contributed to the protocol in the methodological design and provided clinical expertise. MALO contributed to the protocol with the statistical design and provided clinical expertise. CBU is the principal investigator and has contributed to the concept and study design, provided clinical expertise and manuscript development. All authors read and approved the final manuscript.

Acknowledgements

Not applicable.

1. Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, Whitman JM, et al. Neck pain: clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther 2008;38(9):1e34.

2. Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. England; 2015 Feb;90(2):284–99.

3. Daffner SD, Hilibrand AS, Hanscom BS, Brislin BT, Vaccaro AR, Albert TJ. Impact of neck and arm pain on overall health status. Spine (Phila Pa 1976). 2003 Sep 1;28(17):2030-5.

4. Treleaven J. Sensorimotor disturbances in neck disorders affecting postural stability, head and eye movement control. Man Ther. 2008;13(1):2–11.

5. Treleaven J, Jull G, Sterling M. Dizziness and unsteadiness following whiplash injury: characteristic features and relationship with cervical joint position error. J Rehabil Med. 2003;35(1):36–43.

6. Vincent K, Maigne J, Fischhoff C, Lanlo O, Dagenais S. Systematic review of manual therapies for nonspecific neck pain. Jt Bone Spine. 2013;80(5):508–15.

7. Gross AR, Paquin JP, Dupont G, Blanchette S, Lalonde P, Cristie T, et al. Exercises for mechanical neck disorders: A Cochrane review update. Man Ther. 2016;24:25–45.

8. Miller J, Gross A, D’Sylva J, Burnie SJ, Goldsmith CH, Graham N, et al. Manual therapy and exercise for neck pain: A systematic review. Man Ther. 2010;15(4):334–54.

9. Holt KR, Haavik H, Elley CR. The effects of manual therapy on balance and falls: A systematic review. J Manipulative Physiol Ther. 2012;35(3):227–34.

10. Boyd L, Briggs C, et al. Muscle spindle distribution, morphology, and density in the longis colli and multifidus muscles of the cervical spine. Spine, 2002; 27(7): 694-701.

11. Bolton PS, Kerman IA, et al. Influences of neck afferents on sympathetic and respiratory nerve activity. Brain Res Bull. 1998;47(5):413–9

12. Selbie WS, Thomson DB, et al. Suboccipital muscles in the cat neck: morphometry and histochemistry of the rectus capitis muscle complex. J Morphol. 1993;216(1):47–63.

13. Hellstrom F, Roatta S, et al. Responses of muscle spindles in feline dorsal neck muscles to electrical stimulation of the cervical sympathetic nerve. Exp Brain Res 2005;165(3): 328–42.

14. Corneil BD, Olivier E, et al. Neck muscle responses to stimulation of monkey superior colliculus. I. Topography and manipulation of stimulation parameters. J Neurophysiol 2002;88(4): 1980–99.

15. Peterson BW. Current approaches and future directions to understanding control of head movement. Prog Brain Res. 2004;143:369–81.

16. Mergner T, Schweigart G, et al. Eye movements evoked by proprioceptive stimulation along the body axis in humans. Exp Brain Res. 1998;120(4):450–60.

17. Yamagata Y, Yates BJ, et al. Participation of Ia reciprocal inhibitory neurons in the spinal circuitry of the tonic neck reflex. Exp Brain Res. 1991;84(2):461–4.

18. Pera D, Graven-Nielsen T, et al. Inhibition of motor system excitability at cortical and spinal level by tonic muscle pain. Clin Neurophysiol. 2001;112(9):1633–41.

19. Flor H. Cortical reorganisation and chronic pain: implications for rehabilitation. J Rehab Med. 2003;35:66–72.

20. Falla D. Unravelling the complexity of muscle impairment in chronic neck pain. Man Ther. 2004;9(3):125–33.

21. Uhlig Y, Weber BR, et al. Fiber composition and fiber transformation in neck muscles of patients with dysfunction of the cervical spine. J Orthop Res. 1995;13:240–9

22. McPartland JM, Brodeur RR, et al. Chronic neck pain, standing balance, and suboccipital muscle atrophy—a pilot study. J Manipulative Physiol Ther. 1997;20(1):24–9.

23. Field S, Treleaven J, et al. Standing balance: a comparison between idiopathic and whiplash induced neck pain. Man Ther. 2007;13(3):183–191.

24. Saavedra-Hernandez M, Arroyo-Morales M, Cantarero-Villanueva I, Fernandez-Lao C, Castro-Sanchez AM, Puentedura EJ, et al. Short-term effects of spinal thrust joint manipulation in patients with chronic neck pain: a randomized clinical trial. Clin Rehabil. England; 2013 Jun;27(6):504–12

25. Lopez-Lopez A, Alonso Perez JL, Gonzalez Gutierez JL, La Touche R, Lerma Lara S, Izquierdo H, et al. Mobilization versus manipulations versus sustain apophyseal natural glide techniques and interaction with psychological factors for patients with chronic neck pain: randomized controlled trial. Eur J Phys Rehabil Med. 2015 Apr; 51(2):121–32.

26. Heredia-Rizo AM, Pascual-Vaca AO, Cabello MA, et al. Immediate effects of the suboccipital muscle inhibition technique in craniocervical posture and greater occipital nerve mechanosensitivity in subjects with a history of orthodontia use: A randomized trial. J Manipulative Physiol Ther. 2012;35:446–453.

27. Cleland JA, Fritz JM, Whitman JM, Palmer JA. The reliability and constructo validity of the neck disability index and patient specific functional scale in patients with cervical radiculopathy. Spine 2006;31: 598–602.

28. Kovacs FM, Bagó J, Royuela A, Seco J, Giménez S, Muriel A, et al. Psychometric characteristics of the Spanish version of instruments to measure neck pain disability. 2008 Apr;13:1–13.

29. Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. PAIN 1983;17:45–56.

30. Fischer AA. Algometry in diagnosis of musculoskeletal pain and evaluation of treatment outcome: an update. J Muscoskel Pain 1998;6: 5–32.

31. Chesterton LS, Sim J, Wright CC, Foster NE. Interrater reliability of algometry in measuring pressure pain thresholds in healthy humans, using multiple raters. Clin J Pain 2007;23(9):760e6.

32. Parraca JA, Olivares PR, Carbonell-Baeza A, Aparicio VA, Adsuar JC, Gusi N. Test-retest reliability of biodex balance SD on physically active old people. J Hum Sport Exerc. 2011;6(2):444–51.

33. Arnold BL, Schmitz RJ. Examination of balance measures produced by the biodex stability system. J Athl Train. 1998;33(4):323–7.

34. Kovacs FM, Abraira V, Royuela A, Corcoll J, Alegre L, Tomas M, Cano A, Muriel A, Zamora J, DelReal MT, Gestoso M, Mufraggi N. Minimum detectable and minimal clinically important changes for pain in patients with nonspecific neck pain. BMC Musculoskelet Disord. 2008;9:43.

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Editorial decision: Major revision
06 Jun, 2019
Review #2 received at journal
04 Jun, 2019
Reviewer #2 agreed at journal
15 May, 2019
Review #1 received at journal
14 May, 2019
Reviewers invited by journal
25 Apr, 2019
Reviewer #1 agreed at journal
25 Apr, 2019
Editor assigned by journal
17 Apr, 2019
Submission checks completed at journal
15 Mar, 2019
First submitted to journal
12 Mar, 2019

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Manual Therapy Versus Therapeutic Exercise in non-specific chronic neck pain: study protocol for a randomized controlled trial.

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Abstract

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Background

Methods/Design

Participants’ timeline

Discussion

Trial status

List of abbreviations

Declarations

References

Supplementary Files

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Journal Publication

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