Impact of neck rehabilitation on temporomandibular joints and muscle functioning in patients with chronic neck pain
| ISRCTN | ISRCTN14511735 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14511735 |
- Submission date
- 27/08/2020
- Registration date
- 23/09/2020
- Last edited
- 19/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Cervical spine dysfunction is a cause of neck pain. Cervical spine dysfunction occurs in about 70% of the population. Both diagnosis and treatment of these problems are difficult, and in many cases, the effects of therapy are not satisfactory. Existence of jaw (temporomandibular joint) discomfort along with cervical spine disorders is quite common and is associated with many limitations and adverse symptoms for the patient. The exact relationship between neck ailments and temporomandibular dysfunction (TMD) is still unclear. This study aims to verify the functional relationship between the cervical spine and TMJ as well as check whether the therapy focusing only on the cervical region has a real impact on the structures located in the facial area. These tests have practical applications because they can indicate new directions in the diagnosis and therapy of neck and TMD
Who can participate?
Adults aged over 18 years, with chronic neck pain, and also healthy subjects.
What does the study involve?
Participants undergo a three-week rehabilitation program involving manual therapy, massages, exercise and education.
What are the possible benefits and risks of participating?
The benefits to those taking part are the chance to receive 3 weeks of rehabilitation, which may improve health and reduce chronic neck pain. The intervention is provided by qualified physiotherapists, so there is no risk for participants.
Where is the study run from?
1. Rzeszow University in Poland
2. University of Physical Education in Kraków (Poland)
When is the study starting and how long is it expected to run for?
April 2011 to December 2014
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Anna Mika, anna.mika@awf.krakow.pl
Contact information
Scientific
University of Physical Education in Krakow
al. Jana Pawla II 78
Kraków
31-571
Poland
 ORCID ID |
0000-0002-4366-5091 |
|---|---|
| Phone | +48 126831134 |
| anna.mika@awf.krakow.pl |
Study information
| Study design | Interventional non-randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Impact of cervical spine rehabilitation on temporomandibular joints functioning, and bioelectrical activity of cervical and masticatory system muscles in patients with idiopathic neck pain |
| Study acronym | CRTMD |
| Study hypothesis | The aim of this study is to assess the impact of a 3-week neck-only rehabilitation programme without direct intervention in the craniofacial area on the bioelectric activity of both the cervical spine and muscles in the craniofacial area among patients with idiopathic neck pain. Experimental group undergo three-weeks rehabilitation program, which is individual for each patient and comprise the following standard treatments for chronic pain of the musculoskeletal system. |
| Ethics approval(s) | Approved 05/03/2012, Ethical Committee of Rzeszow University in Poland (al. Tadeusza Rejtana 16C, 35-310 Rzeszów, Poland; +48 17 872 19 20; komisjabioetur@gmail.com), ref: No 3/05/2012 |
| Condition | Idiopathic neck pain |
| Intervention | The experimental group undergo a 3-week rehabilitation program, which is individual for each patient and comprises the following standard treatments for chronic pain of the musculoskeletal system: manual therapy (soft tissue therapy of the neck and the shoulder girdle, trigger point therapy, manual cervical traction, classical massage, myofascial release); individual exercises with a therapist (weight free, respiratory, fit ball and body posture correction exercises); physical therapy (sollux lamp); education on the character of the dysfunction, body posture correction techniques, ergonomics and everyday mouth hygiene. The rehabilitation was provided five times a week lasting each time for about 2 h. Age-matched subjects (control group) who were cervical pain-free, had no cervical spine and TMJ dysfunctions or were not in the process of current orthodontic treatment did not undergo any therapy. |
| Intervention type | Mixed |
| Primary outcome measure | Measured at baseline and 3 weeks: 1. Pain intensity measured using 10-point visual analogue scale (VAS) 2. Temporomandibular joints functioning measured using the Helkimo clinical dysfunction index (Di) 3. Head posture and range of motion in the cervical spine - measured with measuring tape 4. Cervical Spine and craniofacial muscles bioelectrical activity (sEMG) assessed by surface electromyography |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/04/2011 |
| Overall study end date | 22/12/2014 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 60 |
| Participant inclusion criteria | Patient: 1. Chronic idiopathic neck pain Patient and control: 2. Aged 18 years or above |
| Participant exclusion criteria | Patient: 1. Cervical spine injury 3 months prior to the therapy 2. Regular use of painkillers or steroids, without possibility to withdraw it for the whole duration of the therapy 3. Radiographically diagnosed developmental and degenerative abnormalities of the cervical spine as; spinal stenosis, subluxations, spinal disc herniation 4. Orthodontic treatment (braces, aligners); removable dentures Control: 5. Cervical pain 6. Cervical spine and TMJ dysfunction 7. In the process of current orthodontic treatment |
| Recruitment start date | 02/04/2012 |
| Recruitment end date | 22/12/2014 |
Locations
Countries of recruitment
- Poland
Study participating centres
Rzeszów
35-310
Poland
Kraków
31-571
Poland
Sponsor information
University/education
al. Tadeusza Rejtana 16C
Rzeszów
35-310
Poland
| Phone | +48 17 872 10 00 |
|---|---|
| info@ur.edu.pl | |
| Website | https://www.ur.edu.pl/en |
"ROR" |
https://ror.org/03pfsnq21 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/04/2021 | 27/04/2021 | Yes | No | |
| Results article | 07/10/2021 | 19/10/2021 | Yes | No |
Editorial Notes
19/10/2021: Publication reference added.
27/04/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
28/08/2020: Trial’s existence confirmed by Ethical Committee of Rzeszow University in Poland.
