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
Primary Purpose
Chronic Neck Pain, TMD, Temporomandibular Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
gymnastics plus silicon dental bite pad
gymnastics only
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Neck Pain focused on measuring gymnastic, dental bite pad
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
Sites / Locations
- Institute of medical physics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
gymnastic (control group)
gymnastic plus dental bite pads (intervention group)
Arm Description
"usual care" home gymnastics programme for 12 weeks, which consists of three different 3-minute sequences to be performed daily.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
kyphosis angle
Posture (sagittal curvature / kyphosis angle (kyphometer n. Debrunner) in standing position
Shoulder mobility
End grade active flexion in sitting position (measurement bilaterally synchronous with goniometer))
TMD symptoms (questionnaires)
TMD Pain Screener, German version DC/TMD Symptom Questionnaire, German version Functional diagnostics of the temporomandibular joint
Full Information
NCT ID
NCT05302466
First Posted
December 1, 2021
Last Updated
January 2, 2023
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT05302466
Brief 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
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain, TMD, Temporomandibular Dysfunction
Keywords
gymnastic, dental bite pad
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gymnastic (control group)
Arm Type
Active Comparator
Arm Description
"usual care" home gymnastics programme for 12 weeks, which consists of three different 3-minute sequences to be performed daily.
Arm Title
gymnastic plus dental bite pads (intervention group)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
gymnastics plus silicon dental bite pad
Other Intervention Name(s)
TJ Motion
Intervention Description
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
Other
Intervention Name(s)
gymnastics only
Other Intervention Name(s)
exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neck pain (NRS)
Description
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.
Time Frame
Baseline, 6 Weeks, 12 Weeks
Secondary Outcome Measure Information:
Title
Mobility of the cervical spine (range of motion (ROM))
Description
Sensor-based digital recording of flexion, extension, rotation, lateral flexion during active performance in a seated position (Mobeefit SportMed A.G. SA, Echternach, Luxembourg)
Time Frame
Baseline, 12 Weeks
Title
kyphosis angle
Description
Posture (sagittal curvature / kyphosis angle (kyphometer n. Debrunner) in standing position
Time Frame
Baseline, 12 Weeks
Title
Shoulder mobility
Description
End grade active flexion in sitting position (measurement bilaterally synchronous with goniometer))
Time Frame
Baseline, 12 Weeks
Title
TMD symptoms (questionnaires)
Description
TMD Pain Screener, German version DC/TMD Symptom Questionnaire, German version Functional diagnostics of the temporomandibular joint
Time Frame
Baseline, 12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon von Stengel
Organizational Affiliation
University Erlangen-Nuremberg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sebastian Willert
Organizational Affiliation
University Erlangen-Nuremberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wolfgang Kemmler, PhD
Organizational Affiliation
University Erlangen-Nuremberg
Official's Role
Study Director
Facility Information:
Facility Name
Institute of medical physics
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91052
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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