Chronic Neck Pain, Temporomandibular Dysfunction, TMD
Conditions
Keywords
gymnastic, dental bite pad
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.
Interventions
DEVICEgymnastics 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.
OTHERgymnastics 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.
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Computer-assisted block randomisation (stratification according to pain intensity) is carried out by an independent statistician. The blinding of the study refers to the measurement assistants who do not know/are not allowed to ask about the respective status of the participant.
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck pain (NRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mobility of the cervical spine (range of motion (ROM)) | 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) |
| kyphosis angle | Baseline, 12 Weeks | Posture (sagittal curvature / kyphosis angle (kyphometer n. Debrunner) in standing position |
| Shoulder mobility | Baseline, 12 Weeks | End grade active flexion in sitting position (measurement bilaterally synchronous with goniometer)) |
| TMD symptoms (questionnaires) | Baseline, 12 Weeks | TMD Pain Screener, German version DC/TMD Symptom Questionnaire, German version Functional diagnostics of the temporomandibular joint |
Countries
Germany
Outcome results
None listed