Chronic Neck PainNCT05302466
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
A study testing gymnastics plus silicon dental bite pad and gymnastics only in people with Chronic Neck Pain and TMD, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Chronic Neck Pain, TMD, Temporomandibular Dysfunction
- What is being tested?
- gymnastics plus silicon dental bite pad and gymnastics only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- gymnastics plus silicon dental bite pad, gymnastics only
- Keywords
- gymnastic, dental bite pad
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gymnastics plus silicon dental bite padDevice
Also called TJ Motion
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.
gymnastics onlyOther
Also called exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| gymnastic (control group) | Active comparator | "usual care" home gymnastics programme for 12 weeks, which consists of three different 3-minute sequences to be performed daily. Receives: Other: gymnastics only |
| gymnastic plus dental bite pads (intervention group) | Experimental | 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. Receives: Device: gymnastics plus silicon dental bite pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 Weeks, 12 Weeks
Secondary outcomes (4)
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)
Measured: Baseline, 12 Weeks
kyphosis angle
Posture (sagittal curvature / kyphosis angle (kyphometer n. Debrunner) in standing position
Measured: Baseline, 12 Weeks
Shoulder mobility
End grade active flexion in sitting position (measurement bilaterally synchronous with goniometer))
Measured: Baseline, 12 Weeks
TMD symptoms (questionnaires)
TMD Pain Screener, German version DC/TMD Symptom Questionnaire, German version Functional diagnostics of the temporomandibular joint
Measured: Baseline, 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Dec 2021
- Primary completion31 Mar 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon von Stengel, Study chair, University Erlangen-NurembergSebastian Willert, Principal investigator, University Erlangen-NurembergWolfgang Kemmler, PhD, Study director, University Erlangen-Nuremberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302466
- Sponsor's protocol ID
- TJ_2021
- Status last verified
- Jan 2023
- First submitted
- 1 Dec 2021
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05302466
- Acronym / sponsor ID
- TJ_2021
- Conditions
- Chronic Neck Pain, TMD, Temporomandibular Dysfunction
- Keywords
- gymnastic, dental bite pad
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| gymnastic (control group) | Active comparator | Other: gymnastics only"usual care" home gymnastics programme for 12 weeks, which consists of three different 3-minute sequences to be performed daily. |
| gymnastic plus dental bite pads (intervention group) | Experimental | Device: gymnastics plus silicon dental bite padIdentical 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gymnastics plus silicon dental bite padAlso: TJ MotionGymnastics (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. | Device | gymnastic plus dental bite pads (intervention group) |
| gymnastics onlyAlso: exerciseGymnastics, 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 | gymnastic (control group) |
Primary outcome
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.
4 secondary outcomes
Mobility of the cervical spine (range of motion (ROM))
Time frame: Baseline, 12 Weeks
kyphosis angle
Time frame: Baseline, 12 Weeks
Shoulder mobility
Time frame: Baseline, 12 Weeks
TMD symptoms (questionnaires)
Time frame: Baseline, 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon von Stengel study chair
University Erlangen-Nuremberg
Sebastian Willert principal investigator
University Erlangen-Nuremberg
Wolfgang Kemmler, PhD study director
University Erlangen-Nuremberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gymnastics plus silicon dental bite pad and gymnastics only in people with Chronic Neck Pain and TMD, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck pain (NRS) (time frame: Baseline, 6 Weeks, 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.