Condition category
Musculoskeletal Diseases
Date applied
27/08/2020
Date assigned
23/09/2020
Last edited
23/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anna Mika

ORCID ID

https://orcid.org/0000-0002-4366-5091

Contact details

University of Physical Education in Krakow
al. Jana Pawla II 78
Kraków
31-571
Poland
+48 126831134
anna.mika@awf.krakow.pl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

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

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

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

Study design

Interventional non-randomized

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

No participant information sheet available

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

Phase

Drug names

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 trial start date

01/04/2011

Overall trial end date

22/12/2014

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patient:
1. Chronic idiopathic neck pain
Patient and control:
2. Aged 18 years or above

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

100

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

Trial participating centre

Rzeszow University in Poland
al. Tadeusza Rejtana 16C
Rzeszów
35-310
Poland

Trial participating centre

University of Physical Education in Kraków
al. Jana Pawla II 78
Kraków
31-571
Poland

Sponsor information

Organisation

Rzeszów University

Sponsor details

al. Tadeusza Rejtana 16C
Rzeszów
35-310
Poland
+48 17 872 10 00
info@ur.edu.pl

Sponsor type

University/education

Website

https://www.ur.edu.pl/en

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

01/08/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

28/08/2020: Trial’s existence confirmed by Ethical Committee of Rzeszow University in Poland.