Additive Effects of Dental Bite Pads During Gymnastic Exercises for the Relief of Chronic Non-specific Neck Pain in Working Women and Men at a VDU Workplace

Chronic Neck Pain Clinical Trial

Official title:

Additive Effects of Dental Bite Pads During Gymnastic Exercises for the Relief of Chronic Non-specific Neck Pain in Working Women and Men at a VDU Workplace

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05302466
• Other study ID #: TJ_2021
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: January 2023
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study which includes 52 participants suffering from chronic neck pain, determines additional effects of dental bite pads on neck pain and function when performing a 3-month gymnastics programme.

Description:

Chronic neck pain is a common health problem in our society. Targeted gymnastic exercises have a high priority in the context of therapy and have shown positive effects on the symptoms in studies. In the past, direct connections between the temporomandibular joint and complaints of the musculoskeletal system, especially of the shoulder-neck region, have been researched, which are based on neuroanatomical (nerves) and myofascial (muscle-fascia) connections. Against the background of current study results, consideration of these findings could be promising in the therapy of neck pain. A new approach tries to positively influence tension and discomfort in the neck area by changing the position of the temporomandibular joints using dental bite pads. In the planned study, the researchers are specifically investigating the question of the extent to which the placement of dental bite pads (made of silicone) in the molar region during the performance of gymnastic exercises can increase the effect of the exercises on neck pain and the associated restrictions on function and quality of life. The aim of the present project is specifically to record the effect of a 3-month gymnastics programme and a possible additional effect of dental bite pads. In the study, 52 working women and men with a sedentary job at a computer workstation aged 30-65 years are included and randomly divided into two groups. Both groups will perform a specific video-animated exercise programme for 3 minutes 3 times a day over a period of 3 months with the main focus on the shoulder-neck region. One group positions a silicone dental bite pad (TJ Motion; BELY Balance GmbH & Co. KG, Weisendorf, Germany) on the right and left side of the molar region during the exercise. Before the intervention, after 6 weeks and after a further 6 weeks of follow-up, pain and function in the neck area are assessed by questionnaire. At baseline and follow-up, functional tests of spinal and jaw mobility are also performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 15, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Men and women 30-65 LJ
• Chronic non-specific neck pain [4] (at least for 3 months, pain intensity =2 (NRS) on at least 50% of days).
• Sedentary work, VDU work

Exclusion Criteria:

• Specific neck pain (e.g. herniated disc, spinal stenosis, etc.)
• Cervical spine-related neuronal symptoms (paresthesia, brachialgia, paresis)
• Continuous pain medication
• Concurrent other therapy to influence neck pain
• Absence = 2 weeks during the intervention period
• Regular sports training (= 60min/week) in the last 6 months

Related Conditions & MeSH terms

• Chronic Neck Pain
• Neck Pain
• Temporomandibular Dysfunction
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• TMD

Intervention

Device:
• gymnastics plus silicon dental bite pad
Gymnastics (see below) plus dental bite pads. The dental bite pads TJ Motion (BELY Balance GmbH & Co. KG, Weisendorf, Germany) are made of medical silicone. Accordingly, they are BPA- and latex-free, odourless, tasteless and dimensionally stable. The splints are placed on the back molars of the lower jaw and remain in this position in the mouth for 3 minutes during the exercise. After use, the splints are rinsed with water and placed dry in the corresponding storage box.

Other:
• gymnastics only
Gymnastics, which are completed daily (7x/week), each consist of three to six exercises and have a total duration of three minutes. The gymnastic programme contain low-intensity exercises from functional gymnastic or physiotherapy.

Locations

Country	Name	City	State
Germany	Institute of medical physics	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck pain (NRS)	Neck pain. The numerical rating scale (NRS) is a one-dimensional pain scale with which patients can quantify their subjectively felt pain. To do this, the patient is asked to assign their pain to a scale of 0-10. "10" stands for "strongest pain imaginable", "0" for "no pain". The recording is done every evening via a pain diary, in each case for one week, before the start of the intervention and in the 6th and 12th week of the intervention. The pain intensity as the primary endpoint is defined as the mean value over one week.	Baseline, 6 Weeks, 12 Weeks
Secondary	Mobility of the cervical spine (range of motion (ROM))	Sensor-based digital recording of flexion, extension, rotation, lateral flexion during active performance in a seated position (Mobeefit SportMed A.G. SA, Echternach, Luxembourg)	Baseline, 12 Weeks
Secondary	kyphosis angle	Posture (sagittal curvature / kyphosis angle (kyphometer n. Debrunner) in standing position	Baseline, 12 Weeks
Secondary	Shoulder mobility	End grade active flexion in sitting position (measurement bilaterally synchronous with goniometer))	Baseline, 12 Weeks
Secondary	TMD symptoms (questionnaires)	TMD Pain Screener, German version DC/TMD Symptom Questionnaire, German version Functional diagnostics of the temporomandibular joint	Baseline, 12 Weeks