Clinical trial NCT05302466: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
TMD
Temporomandibular Dysfunction
Keywords: gymnastic
dental bite pad
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a monocentric, partially blinded, randomised clinical intervention study (RCT) in a parallel group design with participants from the Erlangen-Nuremberg area.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Neck pain (NRS)
timeFrame: Baseline, 6 Weeks, 12 Weeks
Secondary outcomes:
measure: Mobility of the cervical spine (range of motion (ROM))
timeFrame: Baseline, 12 Weeks
measure: kyphosis angle
timeFrame: Baseline, 12 Weeks
measure: Shoulder mobility
timeFrame: Baseline, 12 Weeks
measure: TMD symptoms (questionnaires)
timeFrame: Baseline, 12 Weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Institute of medical physics
state: Bavaria
Study officials:
affiliation: University Erlangen-Nuremberg
name: Simon von Stengel
role: STUDY_CHAIR
affiliation: University Erlangen-Nuremberg
name: Sebastian Willert
role: PRINCIPAL_INVESTIGATOR
affiliation: University Erlangen-Nuremberg
name: Wolfgang Kemmler, PhD
role: STUDY_DIRECTOR
References: