Protocol summary
-
Study aim
-
The aim of this study was to to compare the efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) with commercially available analgesics in alleviating symptoms of TMDs
-
Design
-
It was a randomized, factorial group, non blinded, single center study including 140 patients in total.
-
Settings and conduct
-
A randomized controlled trial was conducted from March 11, 2020 to December 30, 2022 in Oral & Maxillofacial Surgery Department at Armed Forces Institute of Dentistry, Rawalpindi, Pakistan
-
Participants/Inclusion and exclusion criteria
-
Participants who met specific inclusion criteria were included in the investigation. Individuals between ages of 18 and 65 who had been diagnosed with Temporomandibular Joint Dysfunction (TMD) and were experiencing pain or distress in the temporomandibular joint region met these criteria. To assure the safety and validity of the study results, certain exclusion criteria were established. Excluded from the study were patients with contraindications for TENS or analgesic use, such as pacemakers, epilepsy, or pregnancy. In addition, participants who had previously received TENS or analgesic treatment for TMD were excluded. Patients with severe medical conditions that could not tolerate treatment were also excluded.
-
Intervention groups
-
The study included a total of 140 TMD patients that were randomly assigned to three groups: TENS (n=50), analgesic (n=50), and control group (n=40).
-
Main outcome variables
-
Pain intensity was assessed using the Visual Analog Scale (VAS).
General information
-
Reason for update
-
There was incorrect study design mentioned in study protocol summary.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20230622058557N1
Registration date:
2023-06-27, 1402/04/06
Registration timing:
registered_while_recruiting
Last update:
2023-07-04, 1402/04/13
Update count:
1
-
Registration date
-
2023-06-27, 1402/04/06
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2021-01-01, 1399/10/12
-
Expected recruitment end date
-
2023-07-15, 1402/04/24
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Role of transcutaneous electrical nerve stimulation in temporomandibular joint disorders: a randomized controlled trial
-
Public title
-
TENS in temporomandibular joint dysfunction
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Participants who met specific inclusion criteria were included in the investigation. Individuals between ages of 18 and 65 who had been diagnosed with Temporomandibular Joint Dysfunction (TMD) and were experiencing pain or distress in the temporomandibular joint region met these criteria.
Dysfunction of masticatory muscles
Restrictive jaw movements at Temporomandibular Joint
Clicking sound at Temporomandibular Joint
Sensitivity to palpation at Temporomandibular Joint
Exclusion criteria:
patients with contraindications for TENS or analgesic use, such as pacemakers, epilepsy, or pregnancy
participants who had previously received TENS or analgesic treatment for TMD were excluded
severe medical conditions
-
Age
-
From 18 years old to 65 years old
-
Gender
-
Both
-
Phase
-
4
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
140
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Randomization was performed using a sealed envelope with a computer-generated random allocation for each patient. According to the this, patients were randomly divided to receive either be in the TENS Group, Analgesics Group or Control Group.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Crossover
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-03-09, 1398/12/19
-
Ethics committee reference number
-
Ref:905/Trg-ABP1K2
Health conditions studied
1
-
Description of health condition studied
-
Temporomandibular joint disorder: a group of conditions that cause pain and dysfunction in the jaw joint and muscles that control jaw movement.
-
ICD-10 code
-
M26.6
-
ICD-10 code description
-
Temporomandibular joint disorders
Primary outcomes
1
-
Description
-
Decrease in Pain as shown by Decrease in VAS Pain Ratings
-
Timepoint
-
1,2,3,4 Weeks after intervention
-
Method of measurement
-
Visual Analogue Score (VAS)
Secondary outcomes
1
-
Description
-
Functional Impairment- Relief in mouth opening
-
Timepoint
-
2,3,4 Weeks after intervention
-
Method of measurement
-
MMO- Millimeter mouth opening
Intervention groups
1
-
Description
-
Intervention group: TENS group. ATENS machine is a small, battery-operated device that has leads connected to sticky pads called electrodes which were placed in close proximity to the temporomandibular joint and it sends low voltage electrical currents stimulating the nerves. TENS parameters, including frequency, pulse duration, and intensity, were established in accordance with established TMD treatment guidelines.
-
Category
-
Treatment - Devices
2
-
Description
-
Intervention group: Analgesic Group. The analgesic group was administered commercially available analgesics for the treatment of TMD discomforts i.e. Naproxen (500mg twice daily) and muscle relaxant, Diclofenac Potassium (50mg twice daily).
-
Category
-
Treatment - Drugs
3
-
Description
-
Control group: The control group received no intervention but generalized counselling to decrease stress and heat therapy to relief pain.
-
Category
-
Other
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Armed Forces Institute of Dentistry
-
Proportion provided by this source
-
100
-
Public or private sector
-
Private
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Other
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
It is the organization's policy to not share IPD.
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available
-
Title and more details about the data/document
-
The data is entered in SPSS Software.
-
When the data will become available and for how long
-
6 months after publication for a period of 3 months.
-
To whom data/document is available
-
To Medical and Dental Academic Institutes.
-
Under which criteria data/document could be used
-
Academic professionals studying in Medical & Dental Institutes.
-
From where data/document is obtainable
-
Email to investigator
-
What processes are involved for a request to access data/document
-
Email to investigator
-
Comments
-