The effect of adding Temporomandibular joint manual therapy to routine physiotherapy on the improvement of patients with non-specific chronic neck pain
The aim of this study is to evaluate the effect of adding Temporomandibular joint manual therapy to routine physiotherapy on the improvement of patients with non-specific chronic neck pain. This is an experimental study and interventional clinical trial that is randomized, parallel and double-blind. For inclusion, people with non-specific chronic neck pain, which they are also suffering from the Temporomandibular joint disorders have to be present. In this case, there are pain and limitations in range of motion of the Temporomandibular joint and pain and tenderness in at least two related muscles. Patients with neurological disorders, absence of pain in the Temporomandibular joint, malignancy and infection and acute muscle trauma were excluded. The number of 20 was determined for each group. Initially, patients will randomly divided into two groups: group A (They will receive routine physiotherapy treatments for neck pain) and group B (They will receive Temporomandibular joint manual therapy in addition to routine physiotherapy treatments for neck pain). Then both groups will receive their treatments in six sessions for two days a week over a period of 21 days. In order to evaluate the effects of intervention, we will use the visual analogue scale of pain, neck disability index and the range of motion of neck without pain. The assessments for all patients will take place at the first session, at the last session and one month after treatment as follow-up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012732221N1
Registration date:2017-02-13, 1395/11/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-13, 1395/11/25
Registrant information
Name
Maryam Ghodrati
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 3652
Email address
ma.ghodrati@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2017-01-03, 1395/10/14
Expected recruitment end date
2017-02-16, 1395/11/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding Temporomandibular joint manual therapy to routine physiotherapy on the improvement of patients with non-specific chronic neck pain
Public title
The effect of Temporomandibular joint manual therapy on the improvement of patients with non-specific chronic neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: People with non-specific chronic neck pain, which they are also suffering from the Temporomandibular joint disorders. In this case, there are the pain and limitations in range of motion of the Temporomandibular joint and pain and tenderness in at least two related muscles.
Exclusion criteria: Neurological disorders; Absence of pain in the Temporomandibular joint; Malignancy and infection; Acute muscle trauma
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The University of Social Welfare and Rehabilitation Sciences (USWRS)
Street address
kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Postal code
1985713834
Approval date
2017-01-02, 1395/10/13
Ethics committee reference number
IR.uswr.rec.1395.355
Health conditions studied
1
Description of health condition studied
Temporomandibular joint disorders
ICD-10 code
K07.6
ICD-10 code description
Temporomandibular joint disorders
2
Description of health condition studied
non-specific chronic neck pain
ICD-10 code
R52.2
ICD-10 code description
Other chronic pain
Primary outcomes
1
Description
Neck disability index (NDI)
Timepoint
At the first session, at the last session and one month after
Method of measurement
Neck disability index (NDI)
2
Description
The pain
Timepoint
At the first session, at the last session and one month after
Method of measurement
Visual Analogue Scale(VAS)
3
Description
The range of motion of neck flexion
Timepoint
At the first session, at the last session and one month after
Method of measurement
Goniometer
4
Description
The range of motion of neck extention
Timepoint
At the first session, at the last session and one month after
Method of measurement
Goniometer
5
Description
The range of motion of neck side bending
Timepoint
At the first session, at the last session and one month after
Method of measurement
Goniometer
6
Description
The range of motion of neck rotation
Timepoint
At the first session, at the last session and one month after
Method of measurement
Goniometer
Secondary outcomes
1
Description
General questionnaire
Timepoint
At the first assessment session
Method of measurement
questionnaire
Intervention groups
1
Description
Common physical therapy treatment interventions for neck pain, which is the same for both groups, include the following:
Soft tissue release, muscle energy techniques and exercise therapy
Category
Rehabilitation
2
Description
In the intervention group, manual therapy of the temporomandibular joint includes the following:
Muscle energy techniques, mobilization and tongue movements and related training in the TMJ
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Street address
kodakyar Ave., daneshjo Blvd.,Evin, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Social Welfare and Rehabilitation Sciences (USWRS)
Full name of responsible person
Negar Akhavan
Street address
kodakyar Ave., daneshjo Blvd.,Evin, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Social Welfare and Rehabilitation Sciences (USWRS)
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Maryam Ghodrati
Position
student of master of physiotherapy
Other areas of specialty/work
Street address
Unit 16, No 23, Abbasi St , karimi St, Andarzgoo Blvd., Tehran, Iran
City
Tehran
Postal code
Phone
+212 2203652
Fax
Email
mary.gh1372@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
zahra mosallanezhad
Position
PhD Physiotherapy
Other areas of specialty/work
Street address
University of Social Welfare and Rehabilitation Sciences (USWR) Koodakyar St., Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Postal code
Phone
+212 2180039
Fax
Email
zmosallanezhad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The University of Social Welfare and Rehabilitation Sciences (USWRS)
Full name of responsible person
Maryam Ghodrati
Position
Student of master of physiotherapy
Other areas of specialty/work
Street address
Unit 16, No 23, Abbasi St , karimi St, Andarzgoo Blvd., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2220 3652
Fax
Email
mary.gh1372@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)