Clinical trial NCT05447338: Manual Therapy in Patients With Neck Pain
Official title: Effectiveness of Post Muscle Inhibition Specific Joint Mobilization on Range of Motion and Pain in Patients With Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Keywords: Neck Pain
Rehabilitation
Therapy
Lead sponsor: Universidad Nacional de Córdoba
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 114
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The sample will be divided into three intervention groups. Two experimental groups and a control group. Experimental group A: Will receive as treatment the specific joint mobilization technique post muscle inhibition (MAEPI). Experimental group B: Will receive the MAEPI technique as treatment and myofascial induction techniques will be added. The control group: will receive two techniques whose effectiveness is scientifically proven. Which are: Maitland central posterior-anterior passive joint mobilization in C2 + Sustained natural apophyseal sliding (SNAG) in rotation on C1.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Degrees of movement
timeFrame: After the 6 treatment sessions that will be carried out in a period of two weeks for all groups (week 3)
Secondary outcomes:
measure: Neck Disability Index
timeFrame: After the 6 treatment sessions that will be carried out in a period of two weeks for all groups (week 3)
Other outcomes:
measure: Numeric pain scale
timeFrame: After the 6 treatment sessions that will be carried out in a period of two weeks for all groups (week 3)
Locations:
city: Córdoba
country: Argentina
facility: Conci Carpinella
Study officials:
affiliation: Universidad Nacional de Córdoba; Argentina
name: Franco Catelotti
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hall TM, Briffa K, Hopper D, Robinson K. Comparative analysis and diagnostic accuracy of the cervical flexion-rotation test. J Headache Pain. 2010 Oct;11(5):391-7. doi: 10.1007/s10194-010-0222-3. Epub 2010 May 28.