Effectiveness of the Osteopathic Treatment in Patients With Nonspecific Cervical Pain

Neck Pain Clinical Trial

Official title:

Effectiveness of the Osteopathic Treatment in Patients With Nonspecific Cervical Pain: Randomized Controlled Pragmatic Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04156308
• Other study ID #: PR407/18
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2019
• Est. completion date: June 2020

Study information

• Verified date: September 2019
• Source: Escola D'osteopatia De Barcelona
• Contact: Oscar Hernandez Amigo
• Phone: +(34) 649.360.771
• Email: oscarha[@]eobosteopatia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In Spain cervical pain affects practically 20% of the population annually, while globally it is estimated that between 22% and 77% of the population will suffer cervical pain at some point in their life. Prevalence increases with age, and is more common in women than in men (1.6: 1). Although the natural evolution of cervical pain tends to improve, the rates of recurrence and chronicity are high. And therefore it becomes an anatomical region of interest in relation to the assessment of the effectiveness and / or effectiveness of the osteopathic therapeutic approach. Different studies prove the efficacy of various manual therapy techniques applied on the cervical and / or upper dorsal region, suggesting significant positive changes in cervical pain and mobility levels in patients with nonspecific cervical pain. It is necessary to bear in mind that the reality of the osteopathic approach to the patient is not limited to the use of a single technique, but that the treatment is formed from a set of them. The ultimate goal is to restore mobility and functionality to a specific region, especially taking into account the concepts of individuality and holism.

A pragmatic experimental comparative trial with three branches of study (osteopathic treatment with 2 different dosages versus active muscle exercise) is proposed.

Description:

At the beginning of the 1st session, a battery of questions will be made as an anamnesis with the objective of evidencing possible risk factors at the therapeutic level. The presence of one or more risk factors will suppose the exclusion of the patient from the study.

Next, a brief osteopathic musculoskeletal evaluation will be made to the patient. This exploration will follow a standardized protocol for all patients in the experimental groups (1 and 2).

The tests to be carried out will be:

• Observation (standing patient):

• Assessment of the anterior projection of the head

• Assessment of the variation in the physiological curves of the spine

• Active test of the cervical spine with the patient in a sitting position.

o Flexo-Extension / Rotations / Lateral inclinations

• Segmental test of joint mobility of the cervical and dorsal spine (patient in sitting and supine position)

• Passive mobility test of the cervical spine (patient in the supine position):

• Flexo-Extension / Rotations / Lateral inclinations

The combination of exercises scheduled at home for all groups is based on the conclusions of different studies, and will consist of:

• Self-resisted active exercise in flexion, rotations and inclinations of the cervical spine.

• Active mobility in its maximum travel (without forcing pain) in flexion, rotations and inclinations of the cervical spine.

• Stretching upper trapezius muscles and scalenes.

• Active mobility in circumferential joints of the glenohumeral joint, and in flexo-extension of the thoracic spine.

The work schedule will be carried out for 7 weeks, at a rate of 5 sessions per week.

It will be the patient himself who will keep a diary record of the activity carried out during the weeks that the trial lasts. The diary will be facilitated by the therapists, and in it the exercises to be performed will be indicated.

For groups 1 and 2, a total of 3 techniques selected from a list of 7 available techniques common to all centers will be applied in each session. The choice of techniques will be based on the results of the examination performed, the particularities of the patient and the clinical experience of the osteopath. In each session the techniques can change under the criteria of the osteopath. However, they will always be 3 and always within the list of available techniques.

For groups 1 and 2, a total of 3 techniques selected from a list of 7 available techniques common to all centers will be applied in each session. The choice of techniques will be based on the results of the examination performed, the particularities of the patient and the clinical experience of the osteopath. In each session the techniques can change under the criteria of the osteopath. However, they will always be 3 and always within the list of available techniques.

For groups 1 and 2, a total of 3 techniques selected from a list of 7 available techniques common to all centers will be applied in each session. The choice of techniques will be based on the results of the examination performed, the particularities of the patient and the clinical experience of the osteopath. In each session the techniques can change under the criteria of the osteopath. However, they will always be 3 and always within the list of available techniques.

The OMT (Osteopathic Manipulative Treatment) techniques that may be applied will be the following:

1. Technique of Inhibition of the suboccipital muscles

2. Functional technique for the middle and deep cervical fascia

3. High-speed cervical spine technique (Cervical wheel C1-C6)

4. High-speed technique in the cervico-dorsal junction (prone position)

5. High speed technique in dorsal column (D1-D12) - (Dog Technique)

6. Muscle stretching technique of the diaphragm (supine decubitus)

7. Thorax joint mobility technique (long lever)

Main Variable:

o Neck Disability Index (NDI). The investigators establish the minimum change to be detected (minimum clinically relevant change) at 5 points. The Spanish version of the NDI will be used, validated by Andrade Ortega et al.24

Secondary Variable:

o Degree of general quality of life, through the "SF-36" Health Survey25.

The data will be reported in the form of a report by the patient himself, who will receive via e-mail (whenever possible) or in printed form the questionnaire to be completed and will deliver to the same center in which the intervention has been carried out.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: June 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The sample will be formed by patients between the ages of 18 and 75 years, who present cervical pain of any intensity and duration, and with a minimum score of 10 points on the Neck Disability Index (NDI)14,15.

Exclusion Criteria:

• Patients who present at the time of recruitment other pathologies or elements that may condition cervical pain, such as: acute shoulder tendinopathy, cervical radiculopathy, chronic diseases of general musculoskeletal involvement (Chronic Fatigue Syndrome and / or Fibromyalgia). Similarly, patients suffering from any type of vertiginous syndrome, who have suffered a whiplash in the last year or who are or have been under treatment for cervical pain in the last 3 months will also be excluded.

The taking of anti-inflammatories by the patient is not taken as a measure of exclusion. If the patient is under pharmacological treatment, it will be recorded and will be taken into account as a co-intervention. However, this treatment will not be modified under any circumstances nor will it be grounds for exclusion from the study.

Related Conditions & MeSH terms

• Manual Therapies
• Neck Pain

Intervention

Other:
• Osteopathic Manipulative Treatment (OMT) - Temp1
A total of 3 techniques selected from a list of 7 available techniques common to all centers will be applied in each session. The choice of techniques will be based on the results of the examination performed, the particularities of the patient and the clinical experience of the osteopath. In each session the techniques can change under the criteria of the osteopath. However, they will always be 3 and always within the list of available techniques.
• Combined Exercises
A home-based pattern of combined exercises based on stretching, active anti-resisted exercises and joint mobility exercises focused on the cervico-dorsal and scapulo-thoracic regions. Whose clinical effectiveness has shown significant positive changes in pain levels and cervical functionality

Locations

Country	Name	City	State
Spain	Clinica Osteopatia Horta	Barcelona
Spain	IntegroSalus	Cabrils	Barcelona
Spain	AXIS	Sant Sadurní d'Anoia	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Escola D'osteopatia De Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (22)

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Andrade Ortega JA, Delgado Martínez AD, Almécija Ruiz R. Validation of the Spanish version of the Neck Disability Index. Spine (Phila Pa 1976). 2010 Feb 15;35(4):E114-8. doi: 10.1097/BRS.0b013e3181afea5d. — 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

Casanova-Méndez A, Oliva-Pascual-Vaca A, Rodriguez-Blanco C, Heredia-Rizo AM, Gogorza-Arroitaonandia K, Almazán-Campos G. Comparative short-term effects of two thoracic spinal manipulation techniques in subjects with chronic mechanical neck pain: a random — View Citation

Côté P, Cassidy JD, Carroll LJ, Kristman V. The annual incidence and course of neck pain in the general population: a population-based cohort study. Pain. 2004 Dec;112(3):267-73. — View Citation

Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Peñas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a m — View Citation

Franke et al. Franke H, Franke J-D, Fryer G. "Osteopathic manipulative treatment for chronic nonspecific neck pain: A systematic review and meta-analysis". International Journal of Osteopathic Medicine. 2015 Dec;18(4):255-67. [doi:10.1186/1471-2474-15-286]

Fredin K, Lorås H. Manual therapy, exercise therapy or combined treatment in the management of adult neck pain - A systematic review and meta-analysis. Musculoskelet Sci Pract. 2017 Oct;31:62-71. doi: 10.1016/j.msksp.2017.07.005. Epub 2017 Jul 21. Review. — View Citation

González-Álvarez FJ, Valenza MC, Torres-Sánchez I, Cabrera-Martos I, Rodríguez-Torres J, Castellote-Caballero Y. Effects of diaphragm stretching on posterior chain muscle kinematics and rib cage and abdominal excursion: a randomized controlled trial. Braz J Phys Ther. 2016 Jun 16;20(5):405-411. doi: 10.1590/bjpt-rbf.2014.0169. — View Citation

Gross A, Langevin P, Burnie SJ, Bédard-Brochu MS, Empey B, Dugas E, Faber-Dobrescu M, Andres C, Graham N, Goldsmith CH, Brønfort G, Hoving JL, LeBlanc F. Manipulation and mobilisation for neck pain contrasted against an inactive control or another active treatment. Cochrane Database Syst Rev. 2015 Sep 23;(9):CD004249. doi: 10.1002/14651858.CD004249.pub4. Review. — View Citation

Gross AR, Paquin JP, Dupont G, Blanchette S, Lalonde P, Cristie T, Graham N, Kay TM, Burnie SJ, Gelley G, Goldsmith CH, Forget M, Santaguida PL, Yee AJ, Radisic GG, Hoving JL, Bronfort G; Cervical Overview Group. Exercises for mechanical neck disorders: A — View Citation

Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014 Mar 7;348:g1687. doi: 10.1136/bmj.g1687. — View 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. Review. — View Citation

Masaracchio M, Cleland JA, Hellman M, Hagins M. Short-term combined effects of thoracic spine thrust manipulation and cervical spine nonthrust manipulation in individuals with mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2 — View Citation

Palacios-Ceña D, Alonso-Blanco C, Hernández-Barrera V, Carrasco-Garrido P, Jiménez-García R, Fernández-de-las-Peñas C. Prevalence of neck and low back pain in community-dwelling adults in Spain: an updated population-based national study (2009/10-2011/12) — View Citation

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Puntumetakul R, Suvarnnato T, Werasirirat P, Uthaikhup S, Yamauchi J, Boucaut R. Acute effects of single and multiple level thoracic manipulations on chronic mechanical neck pain: a randomized controlled trial. Neuropsychiatr Dis Treat. 2015 Jan 12;11:137 — View Citation

Saavedra-Hernández M, Arroyo-Morales M, Cantarero-Villanueva I, Fernández-Lao C, Castro-Sánchez AM, Puentedura EJ, Fernández-de-las-Peñas C. Short-term effects of spinal thrust joint manipulation in patients with chronic neck pain: a randomized clinical t — View Citation

Salom-Moreno J, Ortega-Santiago R, Cleland JA, Palacios-Ceña M, Truyols-Domínguez S, Fernández-de-las-Peñas C. Immediate changes in neck pain intensity and widespread pressure pain sensitivity in patients with bilateral chronic mechanical neck pain: a ran — View Citation

Sprafka S, Ward RC, Neff D. What characterizes an osteopathic principle? Selected responses to an open question. J Am Osteopath Assoc. 1981 Sep;81(1):29-33. — View Citation

Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15. Erratum in: J Manipulative Physiol Ther 1992 Jan;15(1):followi. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of osteopathic treatment	The effectiveness of osteopathic treatment will be assessed using two health questionnaires ("SF-36" and "NDI") compared to an exercise plan in patients with nonspecific cervical pain.	12 weeks
Secondary	Temporal Frequency	The result of the treatment applied in different temporal frequencies will be compared.	12 weeks