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

NCT04115943 | Unknown

• 1 other identifier: FP002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Numerical rating scale (NRS) for neck pain

  The numerical rating scale (NRS) for pain is an 11-point scale ranging from 0 (absence of pain) to 10 (worst possible pain).

  Before and one week after the end of treatment.

Secondary Outcomes (4)

• Change in Pain Catastrophizing Scale (PCS)

  Before and one week after the end of treatment.

• Change in Patient-Specific Functional Scale (PSFS)

  Before and one week after the end of treatment.

• Change in Neck Disability Index (NDI)

  Before and one week after the end of treatment.

• Change in Cervical range of motion (ROM)

  Before and one week after the end of treatment.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Other: Treatment protocol for neck pain; Other: Protocol for release of tongue muscles

Control Group

ACTIVE COMPARATOR

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

Other: Treatment protocol for neck pain

Interventions

Treatment protocol for neck pain 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.

Control Group; Experimental Group

Protocol for release of tongue muscles 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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University

São Paulo, 06454050, Brazil

RECRUITING

MeSH Terms

Conditions

Neck Pain

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Andreia C O Silva, MSc

  Nove de Julho University

  STUDY CHAIR

• Fabiano Politti, PhD

  Nove de Julho University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabiano Politti, PhD

CONTACT

551141950303; politti@uninove.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Fabiano Politti, FT

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 4, 2019
• Study Start: August 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: August 1, 2020
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)