Effect of the Release of the Tongue Muscles in the Treatment of Chronic Non-specific Neck Pain
Primary Purpose
Neck Pain
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Treatment protocol for neck pain
Protocol for release of tongue muscles
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
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.
Sites / Locations
- Nove de Julho UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control Group
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change in Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a self-administered scale that enables the identification of individuals with psychological traits for catastrophizing pain (coping behavior or set of negative thoughts related to a painful experience). The instrument consists of 13 items, divided into 3 subtypes: hopelessness, magnification and rumination, in which the patient will report the degree of thought or feeling described in relation to cervical pain from 0 (does not present the suggested feeling) to 5 (presents the all the time). The total score is given by the sum of all items, ranging from 0 to 52 points.
Change in Patient-Specific Functional Scale (PSFS)
The Patient-Specific Functional Scale (PSFS) is a self-assessment scale on which the patient selects five important activities that are either hindered or impeded due to neck pain. The participant will attribute a score representing the degree of difficulty in executing each activity ranging from 0 ("unable to perform activity") to 10 ("able to perform activity as easily as before the injury or problem").
Change in Neck Disability Index (NDI)
The Neck Disability Index (NDI) is a 10-item questionnaire designed to assess neck pain and disability. The items are organized by type of activity and followed by six different statements expressing progressive levels of functional capability. Each item is scored from 0 to 5 points. The maximum score is 50 points.
Change in Cervical range of motion (ROM)
Cervical range of motion (ROM) will be determined with the aid of a digital camera to capture the movements of flexion, extension, right rotation, left rotation, right lateral inclination and left lateral inclination. Each movement will be performed three times. The participant will be seated with the back supported on the backrest of the chair. The images will be processed using the free Kinovea software (version 0.8.26). Angle measurement will be calculated for each movement, with the highest values considered the ROM.
Full Information
NCT ID
NCT04115943
First Posted
September 30, 2019
Last Updated
October 3, 2019
Sponsor
University of Nove de Julho
1. Study Identification
Unique Protocol Identification Number
NCT04115943
Brief Title
Effect of the Release of the Tongue Muscles in the Treatment of Chronic Non-specific Neck Pain
Official Title
The Effect of the Release of the Tongue Muscles in the Treatment of Chronic Non-specific Neck Pain: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group (CG) will only receive the gold standard method for the treatment of neck pain.
Intervention Type
Other
Intervention Name(s)
Treatment protocol for neck pain
Intervention Description
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
Intervention Name(s)
Protocol for release of tongue muscles
Intervention Description
. 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.
Primary Outcome Measure Information:
Title
Change in Numerical rating scale (NRS) for neck pain
Description
The numerical rating scale (NRS) for pain is an 11-point scale ranging from 0 (absence of pain) to 10 (worst possible pain).
Time Frame
Before and one week after the end of treatment.
Secondary Outcome Measure Information:
Title
Change in Pain Catastrophizing Scale (PCS)
Description
The Pain Catastrophizing Scale (PCS) is a self-administered scale that enables the identification of individuals with psychological traits for catastrophizing pain (coping behavior or set of negative thoughts related to a painful experience). The instrument consists of 13 items, divided into 3 subtypes: hopelessness, magnification and rumination, in which the patient will report the degree of thought or feeling described in relation to cervical pain from 0 (does not present the suggested feeling) to 5 (presents the all the time). The total score is given by the sum of all items, ranging from 0 to 52 points.
Time Frame
Before and one week after the end of treatment.
Title
Change in Patient-Specific Functional Scale (PSFS)
Description
The Patient-Specific Functional Scale (PSFS) is a self-assessment scale on which the patient selects five important activities that are either hindered or impeded due to neck pain. The participant will attribute a score representing the degree of difficulty in executing each activity ranging from 0 ("unable to perform activity") to 10 ("able to perform activity as easily as before the injury or problem").
Time Frame
Before and one week after the end of treatment.
Title
Change in Neck Disability Index (NDI)
Description
The Neck Disability Index (NDI) is a 10-item questionnaire designed to assess neck pain and disability. The items are organized by type of activity and followed by six different statements expressing progressive levels of functional capability. Each item is scored from 0 to 5 points. The maximum score is 50 points.
Time Frame
Before and one week after the end of treatment.
Title
Change in Cervical range of motion (ROM)
Description
Cervical range of motion (ROM) will be determined with the aid of a digital camera to capture the movements of flexion, extension, right rotation, left rotation, right lateral inclination and left lateral inclination. Each movement will be performed three times. The participant will be seated with the back supported on the backrest of the chair. The images will be processed using the free Kinovea software (version 0.8.26). Angle measurement will be calculated for each movement, with the highest values considered the ROM.
Time Frame
Before and one week after the end of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabiano Politti, PhD
Phone
551141950303
Email
politti@uninove.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreia C O Silva, MSc
Organizational Affiliation
Nove de Julho University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fabiano Politti, PhD
Organizational Affiliation
Nove de Julho University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nove de Julho University
City
São Paulo
ZIP/Postal Code
06454050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabiano Politti, PhD
Phone
1141950303
Email
fpolitti@ig.com.br
First Name & Middle Initial & Last Name & Degree
Fabiano Politti
Phone
1141950303
Email
fpolitti@ig.com.br
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of the Release of the Tongue Muscles in the Treatment of Chronic Non-specific Neck Pain
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