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

NCT ID: NCT05302466

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-12-15

Brief 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.

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.

Conditions

Chronic Neck Pain; TMD; Temporomandibular Dysfunction

Study Design

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

Study Groups

gymnastic (control group)

"usual care" home gymnastics programme for 12 weeks, which consists of three different 3-minute sequences to be performed daily.

Group Type: ACTIVE_COMPARATOR

gymnastics only

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

gymnastics plus silicon dental bite pad

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

TJ Motion; exercise

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon von Stengel

Role: STUDY_CHAIR

University Erlangen-Nuremberg

Sebastian Willert

Role: PRINCIPAL_INVESTIGATOR

University Erlangen-Nuremberg

Wolfgang Kemmler, PhD

Role: STUDY_DIRECTOR

University Erlangen-Nuremberg

Locations

Institute of medical physics

Erlangen, Bavaria, Germany

Countries

Germany

Other Identifiers

TJ_2021

Identifier Type: -

Identifier Source: org_study_id