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

January 2, 2023 updated by: University of Erlangen-Nürnberg Medical School
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91052
        • Institute of medical physics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: gymnastic (control group)
"usual care" home gymnastics programme for 12 weeks, which consists of three different 3-minute sequences to be performed daily.
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.
Other Names:
  • exercise
Experimental: gymnastic plus dental bite pads (intervention group)
Identical home gymnastics programme for 12 weeks, which consists of three different 3-minute sequences to be performed daily plus dental bite pads during exercise. The dental bite pads are placed on the back molars of the lower jaw and remain in this position in the mouth for 3 minutes during the exercise.
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 Names:
  • TJ Motion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck pain (NRS)
Time Frame: Baseline, 6 Weeks, 12 Weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mobility of the cervical spine (range of motion (ROM))
Time Frame: Baseline, 12 Weeks
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
kyphosis angle
Time Frame: Baseline, 12 Weeks
Posture (sagittal curvature / kyphosis angle (kyphometer n. Debrunner) in standing position
Baseline, 12 Weeks
Shoulder mobility
Time Frame: Baseline, 12 Weeks
End grade active flexion in sitting position (measurement bilaterally synchronous with goniometer))
Baseline, 12 Weeks
TMD symptoms (questionnaires)
Time Frame: Baseline, 12 Weeks
TMD Pain Screener, German version DC/TMD Symptom Questionnaire, German version Functional diagnostics of the temporomandibular joint
Baseline, 12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Study Chair: Simon von Stengel, University Erlangen-Nuremberg
  • Principal Investigator: Sebastian Willert, University Erlangen-Nuremberg
  • Study Director: Wolfgang Kemmler, PhD, University Erlangen-Nuremberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ_2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Neck Pain

Clinical Trials on gymnastics only

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe