Effect of the Release of the Tongue Muscles in the Treatment of Chronic Non-specific Neck Pain

NCT ID: NCT04115943

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-08-31

Brief Summary

Background The mechanisms behind non-specific neck pain (NS-NP) have not yet been fully clarified. The anatomic relation between the tongue and structures that attach to the cervical spine suggests a possible clinical relation with a NS-NP.

This study protocol describes a randomized, double-blind, clinical trial, the aim of which is to determine the influence of the release of the tongue muscles on pain intensity, cervical range of motion and neck function in individuals with NS-NP.

Methods/Design Forty patients with NS-NP will be enrolled in a randomized, double-blind, clinical trial. The participants will be randomly allocated to two groups of 20 patients each. The experimental group (EG) will be submitted to a clinical method considered the gold standard for the treatment of neck pain together with a tongue muscle release protocol. The control group (CG) will only receive the gold standard method for the treatment of neck pain. All patients will receive six sessions of treatment at a frequency of twice per week and will be evaluated before and one week after the end of treatment. The primary outcome will be pain intensity measured using a numerical pain rating scale (range: 0 [no pain] to 10 [maximum pain]). The secondary outcomes will be the Pain Catastrophizing Scale, Patient-Specific Functional Scale, Neck Disability Index and cervical range of motion. Comparisons between groups before and after treatment will demonstrate whether the tongue muscle release technique exerts an effect on pain intensity, cervical range of motion and neck function in individuals with NS-NP.

Discussion The purpose of this randomized clinical trial is to evaluate the effect of a tongue muscle release technique on pain intensity, cervical range of motion and neck function in patients with NS-NP. The data will be published after the study is completed. The study will support the practice of evidence-based physical therapy for individuals with nonspecific neck pain.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental Group

The experimental group (EG) will be submitted to a clinical method considered the gold standard for the treatment of neck pain together with a tongue muscle release protocol.

Group Type: EXPERIMENTAL

Treatment protocol for neck pain

Intervention Type: OTHER

The protocol to be used in the study is in accordance with the latest guidelines for the treatment of neck pain associated with limited mobility for patients in the chronic phase. The followed techniques will be performed: i) manual therapy - manipulation or mobilization of the upper cervical spine, manipulation or mobilization of the cervical, cervicothoracic and thoracic regions, manual cervical traction, release of the cervical muscles and muscles of the scapulothoracic region; ii) exercises - strengthening and resistance exercises for the muscles of the scapular girdle, coordination, proprioception and postural training of the cervical and scapulothoracic regions.

Protocol for release of tongue muscles

Intervention Type: OTHER

. The aim is the relaxation of the suprahyoid muscles (mylohyoid, geniohyoid, digastric and stylohyoid) as well as the cervical fascia of the anterior region and soft tissues of the region of the pharynx and larynx.

Control Group

The control group (CG) will only receive the gold standard method for the treatment of neck pain.

Group Type: ACTIVE_COMPARATOR

Treatment protocol for neck pain

Intervention Type: OTHER

The protocol to be used in the study is in accordance with the latest guidelines for the treatment of neck pain associated with limited mobility for patients in the chronic phase. The followed techniques will be performed: i) manual therapy - manipulation or mobilization of the upper cervical spine, manipulation or mobilization of the cervical, cervicothoracic and thoracic regions, manual cervical traction, release of the cervical muscles and muscles of the scapulothoracic region; ii) exercises - strengthening and resistance exercises for the muscles of the scapular girdle, coordination, proprioception and postural training of the cervical and scapulothoracic regions.

Interventions

Treatment protocol for neck pain

The protocol to be used in the study is in accordance with the latest guidelines for the treatment of neck pain associated with limited mobility for patients in the chronic phase. The followed techniques will be performed: i) manual therapy - manipulation or mobilization of the upper cervical spine, manipulation or mobilization of the cervical, cervicothoracic and thoracic regions, manual cervical traction, release of the cervical muscles and muscles of the scapulothoracic region; ii) exercises - strengthening and resistance exercises for the muscles of the scapular girdle, coordination, proprioception and postural training of the cervical and scapulothoracic regions.

Intervention Type: OTHER

Protocol for release of tongue muscles

. The aim is the relaxation of the suprahyoid muscles (mylohyoid, geniohyoid, digastric and stylohyoid) as well as the cervical fascia of the anterior region and soft tissues of the region of the pharynx and larynx.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• History of neck pain for a period of more than three months; score of 10 to 24 on the Neck Disability Index (adapted and validated for the Brazilian population); score of 3 to 6 points on numerical rating scale (NRS) for perceived pain intensity.

Exclusion Criteria

• History of neurological disorders (irradiated pain) or neck surgery; chronic neck pain resulting from a traumatic incident (whiplash); chronic musculoskeletal condition (such as muscular disorder or polyarthritis); fibromyalgia; systemic disease; current pregnancy; having undergone physical therapy, massage or acupuncture in the previous two weeks; or use of analgesic, muscle relaxant, psychotropic agent or anti-inflammatory agent in the previous three days.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Fabiano Politti

Prof. Fabiano Politti, FT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreia C O Silva, MSc

Role: STUDY_CHAIR

Nove de Julho University

Fabiano Politti, PhD

Role: PRINCIPAL_INVESTIGATOR

Nove de Julho University

Locations

Nove de Julho University

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Fabiano Politti, PhD

Role: CONTACT

politti@uninove.br

551141950303

Facility Contacts

Fabiano Politti, PhD

Role: primary

fpolitti@ig.com.br

1141950303

Fabiano Politti

Role: backup

fpolitti@ig.com.br

1141950303

Other Identifiers

FP002

Identifier Type: -

Identifier Source: org_study_id