Manual Therapy in Patients With Neck Pain

Universidad Nacional de Córdoba

Status: Enrolling

Conditions: Neck Pain

Treatments: Procedure: Myofascial inductions; Horizontal induction of the TMJ.; Procedure: Deep myofascial induction of the external pterygoid; Procedure: Myofascial inductions; Posterior elongation of the cervical fascia in the supine position; Procedure: Maitland C2; Procedure: Specific joint mobilization post muscle inhibition on C2; Procedure: Myofascial induction of pectoralis major and minor; Procedure: Myofascial induction sternocleidomastoid muscles; Procedure: Intraoral mifascial induction of the internal pterygoid; Procedure: Myofascial inductions; Suboccipital induction; Procedure: Specific joint mobilization post muscle inhibition on C1; Procedure: Myofascial induction, of the fascia of the subscapularis muscle; Procedure: Intraoral myofascial induction of the masseter; Procedure: SNAG C1; Procedure: Myofascial induction; upper trapezius; Procedure: Myofascial induction; Angle of the scapula; Procedure: Myofascial inductions; Synchronization of the temporal bones PHASE 1; Procedure: Myofascial inductions; Synchronization of the temporal bones PHASE 2

Study type: Interventional

Funder types: Other

Identifiers

NCT05447338

4241

Details and patient eligibility

About

Neck pain is a common clinical condition of some diseases that affect the soft tissues, musculotendinous structures and joints of the cervical spine. It is characterized by pain in the posterior and lateral muscles of the neck, muscle contractures and partial functional impotence. An important finding is that approximately 60% of total cervical rotation takes place at C1-C2, regardless of age. The test used to diagnose dysfunction of the upper cervical spine is the Cervical Rotation Flexion Test (CRFT) and is measured in degrees through various instruments, the most current validated by scientific literature are mobile applications (Clinometer and Compass ). Having in clear the importance of the location (C1-C2) of the origin of many of the symptoms and signs that cervicalgia generates and mainly the restriction of the range of movement that they produce in the cervical spine. It is that the manual therapy technique: Joint mobilization post muscular inhibition (MAEPI) that is included in this study for its analysis, is directed to this segment of the cervical spine. This differs from other similar techniques, in terms of location and movement of the joint surfaces, which have been previously studied and have shown their effectiveness (techniques that will be used in the control group), in that the micro movements of the joint surfaces ( joint arthrokinematics) based on the principles of Kaltenborn-Evjenth will be combined with the principles of the hold relax technique belonging to the Proprioceptive Neuromuscular Facilitation method. The main therapeutic objective of the MAEPI technique is to improve mobility and reduce pain in the cervical spine.

Hypothesis: The MAEPI technique will improve mobility and reduce neck pain as well as other symptoms associated with neck pain, such as headache, dizziness and nausea, and will be more effective than those of the control group (Maitland central posterior-anterior passive joint mobilization in C2 and natural apophyseal slippage sustained (SNAG) in rotation about Mulligan's C1). The MAEPI technique will be more effective when applied later to myofascial induction techniques.

Full description

Main goal

-Determine the effectiveness of the MAEPI applied on C1-C2 on the improvement of the range of motion and pain in patients with mechanical neck pain. As well as its effectiveness after performing myofascial induction techniques.

Specific objectives

• Identify the disability index, the intensity of the pain and the degree of mobility of the patients before and after the application of the proposed treatment protocols.
• Identify other symptoms associated with neck pain, such as dizziness, headache and nausea before and after the application of treatment protocols.
• Establish whether there are significant differences in terms of ROM between the proposed protocols, taking into account age, sex, work activity of individuals with neck pain in relation to evolution.

Sample size: The sample size estimate was based on data from previous studies. The standard deviation of 11.1º of the range of motion of the average of the CRFT measurements in patients with upper cervical dysfunction was used. The calculation was performed using the GRANMO sample size calculator (version 7). For an analysis of variance, accepting an alpha risk of 0.05 and a beta risk of less than 0.2 in a unilateral contrast, 38 subjects are needed in each group to detect a minimum difference of 8º between two groups, assuming that there are 3 groups and a deviation 11.1º standard. A rate of loss to follow-up of 10% has been estimated. In the case of repeated paired means by group (experimental group A, MAEPI), accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 16 subjects are required to detect a difference equal to or greater than 8 degrees. A standard deviation of 11.1 is assumed. A rate of loss to follow-up of 0% has been estimated.

Data analysis: The InfoStat program will be used. The data will be analyzed according to the nature of each variable in the ANAVA study, non-linear regression, categorical, correlational data and multiple comparisons test (Fisher's test), establishing significant differences when p<0.05 for all cases. The variables dizziness, headache and nausea: they will be evaluated using a qualitative table and later they will be compared using the Chi square test. In the experimental group A: MAEPI, the t test will be performed for paired data (before and after, for the intervention group of the technique alone).

Expected results

Regarding therapeutic effects, it is expected that:

1. Experimental Group A is superior to the Control Group.
2. Experimental Group B is superior to Experimental Group A.

Enrollment: 114 estimated patients

Sex: All

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• You must have a medical indication for cervical physiotherapy.
• Must present decreased ROM of the upper cervical spine assessed with CRFT, either acute or subacute and of a mechanical type or PN and grade I and II of severity according to The Neck Pain Task Force.

Exclusion criteria

• Joint instability, dislocations, fractures or stenosis of the cervical spinal canal.
• Malformations and/or bony alterations of the cervical spine or the brain.
• Head injury or whiplash in the last 10 years. Infections, unhealed wounds, tumors, vascular pathology or cancer that compromises the cervical spine and/or the brain.
• Being under treatment with anti-inflammatories, muscle relaxants or some type of pain reliever.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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114 participants in 3 patient groups

Specific joint mobilization post muscle inhibition on C1 and C2

Experimental group

Description:

Experimental technique alone, with its two variants. That applies a sliding of the articular surfaces of the atlas and axis after a muscular reflex inhibition (proprioceptive neuromuscular facilitation). Between 1 and 5 mobilizations will be carried out per variant of the technique. There will be 4 treatment sessions distributed over 2 weeks.

Treatment:

Procedure: Specific joint mobilization post muscle inhibition on C1

Procedure: Specific joint mobilization post muscle inhibition on C2

Specific joint mobilization post muscle inhibition on C1 and C2 + myofascial inductions

Experimental group

Description:

Experimental technique alone, with its two variants. That applies a sliding of the articular surfaces of the atlas and axis after a muscular reflex inhibition (proprioceptive neuromuscular facilitation). Between 1 and 5 mobilizations will be carried out per variant of the technique. Myofascial inductions will also be applied to the cranial and cervical fascia, as well as to the suboccipital, pectoral, angular scapula, sternocleidomastoid, trapezius, internal and external pterygoid, masseter and temporal muscles. There will be 4 treatment sessions distributed over 2 weeks.

Treatment:

Procedure: Myofascial inductions; Synchronization of the temporal bones PHASE 2

Procedure: Myofascial induction; Angle of the scapula

Procedure: Myofascial inductions; Synchronization of the temporal bones PHASE 1

Procedure: Myofascial induction; upper trapezius

Procedure: Intraoral myofascial induction of the masseter

Procedure: Myofascial induction, of the fascia of the subscapularis muscle

Procedure: Specific joint mobilization post muscle inhibition on C1

Procedure: Intraoral mifascial induction of the internal pterygoid

Procedure: Myofascial induction sternocleidomastoid muscles

Procedure: Myofascial inductions; Suboccipital induction

Procedure: Myofascial induction of pectoralis major and minor

Procedure: Specific joint mobilization post muscle inhibition on C2

Procedure: Myofascial inductions; Posterior elongation of the cervical fascia in the supine position

Procedure: Deep myofascial induction of the external pterygoid

Procedure: Myofascial inductions; Horizontal induction of the TMJ.

Maitland C2 + SNAG C1

Active Comparator group

Description:

The Maitland technique will be applied, central postero-anterior passive joint mobilization in the C2 vertebra. As well as the sustained apophyseal slip technique (SNAG) in rotation on C1. The dosage is from 1 to 5 mobilizations per technique. There will be 4 treatment sessions distributed over 2 weeks.

Treatment:

Procedure: SNAG C1

Procedure: Maitland C2