Clinical trial NCT04156308: Effectiveness of the Osteopathic Treatment in Patients With Nonspecific Cervical Pain
Official title: Effectiveness of the Osteopathic Treatment in Patients With Nonspecific Cervical Pain: Randomized Controlled Pragmatic Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Manual Therapies
Neck Pain
Keywords: osteopathy, osteopathic treatment, non-specific
Lead sponsor: Escola D'osteopatia De Barcelona
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic experimental comparative trial with three branches of study (osteopathic treatment with 2 different dosages versus active muscle exercise) is proposed.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of osteopathic treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Temporal Frequency
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cabrils
country: Spain
facility: IntegroSalus
state: Barcelona
city: Sant Sadurní d'Anoia
country: Spain
facility: AXIS
state: Barcelona
city: Barcelona
country: Spain
facility: Clinica Osteopatia Horta
Study officials:
affiliation: Escola Osteopatia de Barcelona
name: Oscar Hernandez Amigo
role: PRINCIPAL_INVESTIGATOR
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