Manual Therapy in Patients With Neck Pain

Not Applicable

Recruiting

• Conditions: Neck Pain

• Registration Number: NCT05447338
• Lead Sponsor: Universidad Nacional de Córdoba

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.

Study Timeline

• Study Start: 2021-08-30
• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28
• Primary Completion: 2026-08
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Degrees of movement	After the 6 treatment sessions that will be carried out in a period of two weeks for all groups (week 3)	The cervical flexion-rotation test (CFRT) will be measured in degrees of motion. CFRT is effective in evaluating the presence/absence of upper cervical spine dysfunction. If there are symptoms and the range is decreased by more than 10º (normal is 44º on each side), the test is considered positive and, therefore, there is a limitation in the C1-C2 level. The instrument that will be used to measure the rotation of the upper cervical spine in degrees will be the Compass mobile application that has been validated to measure cervical ROM. The goal is to measure the change in range of motion before and after treatment.

Secondary Outcome Measures

Name	Time	Method
Neck Disability Index	After the 6 treatment sessions that will be carried out in a period of two weeks for all groups (week 3)	It is a 10-item questionnaire that measures disability related to a patient's neck pain. Each question is measured on a scale of 0 (no disability) to 5, and an overall score of 100 is calculated by adding the score for each item and multiplying it by two. A higher NDI score means greater patient perceived disability due to neck pain. The "minimum clinically important change" by patients has been found to be 5-10%. The objective is to measure the change in the disability index before and after treatment.

Trial Locations

Locations (1)

Conci Carpinella; 🇦🇷 Córdoba, Argentina