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

NCT05302466 | Completed

• 1 other identifier: TJ_2021
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Neck Pain; TMD; Temporomandibular Dysfunction

Keywords

gymnastic; dental bite pad

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 Weeks, 12 Weeks

Secondary Outcomes (4)

• Mobility of the cervical spine (range of motion (ROM))

  Baseline, 12 Weeks

• kyphosis angle

  Baseline, 12 Weeks

• Shoulder mobility

  Baseline, 12 Weeks

• TMD symptoms (questionnaires)

  Baseline, 12 Weeks

Study Arms (2)

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.

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.

Device: gymnastics plus silicon dental bite pad

Interventions

gymnastics plus silicon dental bite pad 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.

Also known as: TJ Motion

gymnastic plus dental bite pads (intervention group)

gymnastics only 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.

Also known as: exercise

gymnastic (control group)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Institute of medical physics

Erlangen, Bavaria, 91052, Germany

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Simon von Stengel

  University Erlangen-Nuremberg

  STUDY CHAIR

• Sebastian Willert

  University Erlangen-Nuremberg

  PRINCIPAL INVESTIGATOR

• Wolfgang Kemmler, PhD

  University Erlangen-Nuremberg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a monocentric, partially blinded, randomised clinical intervention study (RCT) in a parallel group design with participants from the Erlangen-Nuremberg area.

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: March 31, 2022
• Study Start: December 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: December 15, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)