Head and Neck CancerTMJNCT05897983
Tens and Rocabado Exercises on TMJ Dysfunction
A study testing Rocabado exercises plus TENS device in people with Head and Neck Cancer, run by Cairo University at 1 site in Egypt.
Trial summary
72 patients who suffers from limited mouth opening and pain in the temporomandibular joint will be selected from oncology department in Zagazig and Cairo university hospitals: patients will be assigned randomly into three groups equal in number, 24 in each group: (group A) will receive Rocabado exercises plus… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Rocabado exercises plus TENS device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Sep 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subject selection will be according to the following criteria:
- Age range between 40-60 years.
- Male and female patients will participate in the study.
- All patients undergo head and neck cancer surgeries (oral cancer surgeries).
- All patients will start treatment within 6 months of radiotherapy termination.
- All patients have pain in different degrees.
- Restricted range of mouth opening < 35 mm.
- All patients enrolled to the study will have their informed consent.
Who cannot join
- The potential participants will be excluded if they meet one of the following criteria:
- Other morbid conditions in the temporomandibular region as rheumatic diseases and neurological diseases.
- Presence of other disorders involving the TMJ (e.g., myalgia, degenerative joint disease, or collagen vascular disease).
- Arthritis.
- Fracture around Temporomandibular Joint (TMJ).
- Dislocation or subluxation of TMJ.
- Inflammatory disorders of TMJ.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Transcutaneous Electrical Nerve Stimulation Plus Rocabado Exercises on Temporomandibular Joint Dysfunction After Head and Neck Surgeries
72 patients who suffers from limited mouth opening and pain in the temporomandibular joint will be selected from oncology department in Zagazig and Cairo university hospitals: patients will be assigned randomly into three groups equal in number, 24 in each group: (group A) will receive Rocabado exercises plus transcutaneous electrical nerve stimulation and traditional exercises .(group B) will receive Rocabado exercises and traditional exercises.(groub C) will receive transcutaneous electrical nerve stimulation and traditional exercises.
Read the detailed description
Patients at group A: patients will receive Rocabado exercises plus transcutaneous electrical nerve stimulation and traditional exercises For 8 weeks : Rocabado exercises form of 2 parts , 6×6×6 exercises and mobilization exercises part (1): 6×6×6 exercises are (1).The rest position of the tongue , (2). Shoulder retraction exercises, (3). Stabilized head flexion ,( 4). The axial extension of the neck , (5).Control of TMJ rotation , (6).Rhythmic stabilization technique .these 6 exercises are repeated 6 times a day for 20 minutes for each repetition.
part (2): Joint mobilization (non-thrust manipulation) includes Distraction, Distraction given with anterior glide, Distraction given with anterior and lateral glide right/left \& Lateral glide without distraction. . These mobilization exercises is done by the therapist 3 times a week for 20 min ,each mobilization is performed for 10-15 times and repeated for 5-6 times.
Transcutaneous electrical nerve stimulation device(TENS):
TENS is used, with a maximum frequency of 120 Hz and an intensity range of 0 to 99.5 mA and the pulse width is between 50-200 microseconds.
TENS electrodes (diameter 35-52 mm) are placed bilaterally on mandibular elevator muscles, on the superficial masseter muscle above the gonial angle, and bilaterally on the upper back (Cacho et al.,2022).
The TENS will be applied for 20 min 2 sessions/week for 8 weeks.
Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily.
- Passive ROM exercises are done by stacked tongue depressors and number of tongue depressors are increased when improvement occur .
- Active Rom exercises are mouth opening and closing ,side way movement and protrusion repeated for 10-15 times with holding for 5 seconds for each position.
- Massaging for cheeks muscles for 2minutes .
Patients at group B: patients will receive Rocabado exercises and traditional exercises For 8 weeks : Rocabado exercises form of 2 parts , 6×6×6 exercises and mobilization exercises part (1): 6×6×6 exercises are (1).The rest position of the tongue ,(2). Shoulder retraction exercises, (3) .Stabilized head flexion , (4).The axial extension of the neck , (5).Control of TMJ rotation ,( 6).Rhythmic stabilization technique .these 6 exercises are repeated 6 times a day for 20 min for each repetition.
part(2): Joint mobilization (non-thrust manipulation) includes Distraction, Distraction given with anterior glide, Distraction given with anterior and lateral glide right/left \& Lateral glide without distraction. . These mobilization exercises is done by the therapist 3 times a week for 20 min ,each mobilization is performed for 10-15 times and repeated for 5-6 times.
Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily.
- Passive ROM exercises are done by stacked tongue depressors and number of tongue depressors are increased when improvement occur .
- Active Rom exercises are mouth opening and closing ,side way movement and protrusion repeated for 10-15 times with holding for 5 seconds for each position.
- Massaging for cheeks for 2minutes . patients at group C: patient will receive Transcutaneous electrical nerve stimulation device(TENS) and traditional exercises: TENS is used, with a maximum frequency of 120 Hz and an intensity range of 0 to 99.5 mA and the pulse width is between 50-200 microseconds.
TENS electrodes (diameter 35-52 mm) are placed bilaterally on mandibular elevator muscles, on the superficial masseter muscle above the gonial angle, and bilaterally on the upper back (Cacho et al.,2022).
The TENS will be applied for 20 min 2 sessions/week for 8 weeks.
Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily.
- Passive ROM exercises are done by stacked tongue depressors and number of tongue depressors are increased when improvement occur .
- Active Rom exercises are mouth opening and closing ,side way movement and protrusion repeated for 10-15 times with holding for 5 seconds for each position.
- Massaging for cheeks for 2 minutes .
- Conditions
- Head and Neck Cancer
- Being tested
- Rocabado exercises plus TENS device
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocabado exercises plus TENS deviceOther
Rocabado exercises form of 2 parts , 6×6×6 exercises part are repeated 6 times a day for 20 minutes for each repetition and mobilization exercises exercises is done by the therapist 3 times a week for 20 min ,each mobilization is performed for 10-15 times and repeated for 5-6 times. TENS is used, with a maximum frequency of 120 Hz and an intensity range of 0 to 99.5 mA and the pulse width is between 50-200 microseconds, The TENS will be applied for 20 min 3 sessions/week for 8 weeks, Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily
| Study group | Role | What they receive |
|---|---|---|
| Rocabado exercises plus TENS | Experimental | Rocabado exercises plus TENS and traditional exercises For 8 weeks,Rocabado exercises form of 2 parts , 6×6×6 exercises part are repeated 6 times a day for 20 minutes for each repetition and mobilization exercises are done by the therapist 3 times a week for 20 min ,each mobilization is performed for 10-15 times and repeated for 5-6 times. TENS is used, with a maximum frequency of 120 Hz and an intensity range of 0 to 99.5 mA and the pulse width is between 50-200 microseconds, The TENS will be applied for 20 min 2 sessions/week for 8 weeks, Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily Receives: Other: Rocabado exercises plus TENS device |
| Rocabado exercises | Experimental | Rocabado exercises part (1): 6×6×6 exercises are (1).The rest position of the tongue , (2). Shoulder retraction exercises, (3). Stabilized head flexion ,( 4). The axial extension of the neck , (5).Control of TMJ rotation , (6).Rhythmic stabilization technique . part (2): Joint mobilization) includes Distraction given with anterior glide, with anterior and lateral glide right/left \& Lateral glide without distraction. Plus Traditional exercises. Receives: Other: Rocabado exercises plus TENS device |
| Transcutaneous electrical nerve stimulation device | Experimental | TENS is used, frequency of 120 Hz and an intensity range of 0 to 99.5 mA and the pulse width is between 50-200 microseconds. TENS electrodes are placed bilaterally on mandibular elevator muscles, on the superficial masseter muscle above the gonial angle, and bilaterally on the upper back ,The TENS will be applied for 20 min 2 sessions/week for 8 weeks. Plus Traditional exercises. Receives: Other: Rocabado exercises plus TENS device |
What is being measured
The primary outcome is the main question the study is designed to answer.
. Vernier caliper:
The vernier, dial, and digital calipers give a direct reading of the distance measured with high accuracy . Vernier calipers commonly used in industry provide a precision to 0.01 mm (10 micrometres), or one thousandth of an inch. They are available in sizes that can measure up to 1,829 mm (72 in) (Agrawal et al., 2015).
Measured: 8 weeks
Mandibular Function Impairment Questionnaire:
The Mandibular Function Impairment Questionnaire is used to assess the limitation of oral function due to mandibular function impairment. Subjects will compelete this self-reported questionnaire that comprise 17 items encompassing the difficulty of chewing hard and soft foods, taking large bites, laughing, eating certain foods, engaging in social activity, and speaking. The items are scored on a 5-point Likert scale (0-4). The overall score is calculated by dividing the sum of the item scores by 68, with a possible range of 0 to 1. A higher score denotes a more serious functional impairment. An overall score of ≤0.3 denotes a low degree, 0.3 ≤ 0.6 denotes a moderate degree, and >0.6 denotes a high degree of functional impairment( Stegenga et al.,1993).
Measured: 8 weeks
Secondary outcomes (1)
Visual Analogue Scale:
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points, zero mean no pain and 10 mean sever pain (Reips and Funke,2008).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start21 Sep 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Mohamed Mohamed Elattar, Cairo University
- Investigators
- rana elattar, master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897983
- Sponsor's protocol ID
- 782015
- Acronym
- TMJ
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transcutaneous Electrical Nerve Stimulation Plus Rocabado Exercises on Temporomandibular Joint Dysfunction After Head and Neck Surgeries
- ClinicalTrials.gov ID
- NCT05897983
- Acronym / sponsor ID
- TMJ / 782015
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
72 patients who suffers from limited mouth opening and pain in the temporomandibular joint will be selected from oncology department in Zagazig and Cairo university hospitals: patients will be assigned randomly into three groups equal in number, 24 in each group: (group A) will receive Rocabado exercises plus transcutaneous electrical nerve stimulation and traditional exercises .(group B) will receive Rocabado exercises and traditional exercises.(groub C) will receive transcutaneous electrical nerve stimulation and traditional exercises.
Detailed description
Patients at group A: patients will receive Rocabado exercises plus transcutaneous electrical nerve stimulation and traditional exercises For 8 weeks : Rocabado exercises form of 2 parts , 6×6×6 exercises and mobilization exercises part (1): 6×6×6 exercises are (1).The rest position of the tongue , (2). Shoulder retraction exercises, (3). Stabilized head flexion ,( 4). The axial extension of the neck , (5).Control of TMJ rotation , (6).Rhythmic stabilization technique .these 6 exercises are repeated 6 times a day for 20 minutes for each repetition.
part (2): Joint mobilization (non-thrust manipulation) includes Distraction, Distraction given with anterior glide, Distraction given with anterior and lateral glide right/left \& Lateral glide without distraction. . These mobilization exercises is done by the therapist 3 times a week for 20 min ,each mobilization is performed for 10-15 times and repeated for 5-6 times.
Transcutaneous electrical nerve stimulation device(TENS):
TENS is used, with a maximum frequency of 120 Hz and an intensity range of 0 to 99.5 mA and the pulse width is between 50-200 microseconds.
TENS electrodes (diameter 35-52 mm) are placed bilaterally on mandibular elevator muscles, on the superficial masseter muscle above the gonial angle, and bilaterally on the upper back (Cacho et al.,2022).
The TENS will be applied for 20 min 2 sessions/week for 8 weeks.
Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily.
- Passive ROM exercises are done by stacked tongue depressors and number of tongue depressors are increased when improvement occur .
- Active Rom exercises are mouth opening and closing ,side way movement and protrusion repeated for 10-15 times with holding for 5 seconds for each position.
- Massaging for cheeks muscles for 2minutes .
Patients at group B: patients will receive Rocabado exercises and traditional exercises For 8 weeks : Rocabado exercises form of 2 parts , 6×6×6 exercises and mobilization exercises part (1): 6×6×6 exercises are (1).The rest position of the tongue ,(2). Shoulder retraction exercises, (3) .Stabilized head flexion , (4).The axial extension of the neck , (5).Control of TMJ rotation ,( 6).Rhythmic stabilization technique .these 6 exercises are repeated 6 times a day for 20 min for each repetition.
part(2): Joint mobilization (non-thrust manipulation) includes Distraction, Distraction given with anterior glide, Distraction given with anterior and lateral glide right/left \& Lateral glide without distraction. . These mobilization exercises is done by the therapist 3 times a week for 20 min ,each mobilization is performed for 10-15 times and repeated for 5-6 times.
Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily.
- Passive ROM exercises are done by stacked tongue depressors and number of tongue depressors are increased when improvement occur .
- Active Rom exercises are mouth opening and closing ,side way movement and protrusion repeated for 10-15 times with holding for 5 seconds for each position.
- Massaging for cheeks for 2minutes . patients at group C: patient will receive Transcutaneous electrical nerve stimulation device(TENS) and traditional exercises: TENS is used, with a maximum frequency of 120 Hz and an intensity range of 0 to 99.5 mA and the pulse width is between 50-200 microseconds.
TENS electrodes (diameter 35-52 mm) are placed bilaterally on mandibular elevator muscles, on the superficial masseter muscle above the gonial angle, and bilaterally on the upper back (Cacho et al.,2022).
The TENS will be applied for 20 min 2 sessions/week for 8 weeks.
Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily.
- Passive ROM exercises are done by stacked tongue depressors and number of tongue depressors are increased when improvement occur .
- Active Rom exercises are mouth opening and closing ,side way movement and protrusion repeated for 10-15 times with holding for 5 seconds for each position.
- Massaging for cheeks for 2 minutes .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rocabado exercises plus TENS | Experimental | Other: Rocabado exercises plus TENS deviceRocabado exercises plus TENS and traditional exercises For 8 weeks,Rocabado exercises form of 2 parts , 6×6×6 exercises part are repeated 6 times a day for 20 minutes for each repetition and mobilization exercises are done by the therapist 3 times a week for 20 min ,each mobilization is performed for 10-15 times and repeated for 5-6 times. TENS is used, with a maximum frequency of 120 Hz and an intensity range of 0 to 99.5 mA and the pulse width is between 50-200 microseconds, The TENS will be applied for 20 min 2 sessions/week for 8 weeks, Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily |
| Rocabado exercises | Experimental | Other: Rocabado exercises plus TENS deviceRocabado exercises part (1): 6×6×6 exercises are (1).The rest position of the tongue , (2). Shoulder retraction exercises, (3). Stabilized head flexion ,( 4). The axial extension of the neck , (5).Control of TMJ rotation , (6).Rhythmic stabilization technique . part (2): Joint mobilization) includes Distraction given with anterior glide, with anterior and lateral glide right/left \& Lateral glide without distraction. Plus Traditional exercises. |
| Transcutaneous electrical nerve stimulation device | Experimental | Other: Rocabado exercises plus TENS deviceTENS is used, frequency of 120 Hz and an intensity range of 0 to 99.5 mA and the pulse width is between 50-200 microseconds. TENS electrodes are placed bilaterally on mandibular elevator muscles, on the superficial masseter muscle above the gonial angle, and bilaterally on the upper back ,The TENS will be applied for 20 min 2 sessions/week for 8 weeks. Plus Traditional exercises. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The subject selection will be according to the following criteria:
- Age range between 40-60 years.
- Male and female patients will participate in the study.
- All patients undergo head and neck cancer surgeries (oral cancer surgeries).
- All patients will start treatment within 6 months of radiotherapy termination.
Key exclusion criteria (7 listed)
- Other morbid conditions in the temporomandibular region as rheumatic diseases and neurological diseases.
- Presence of other disorders involving the TMJ (e.g., myalgia, degenerative joint disease, or collagen vascular disease).
- Arthritis.
- Fracture around Temporomandibular Joint (TMJ).
- Dislocation or subluxation of TMJ.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocabado exercises plus TENS deviceRocabado exercises form of 2 parts , 6×6×6 exercises part are repeated 6 times a day for 20 minutes for each repetition and mobilization exercises exercises is done by the therapist 3 times a week for 20 min ,each mobilization is performed for 10-15 times and repeated for 5-6 times. TENS is used, with a maximum frequency of 120 Hz and an intensity range of 0 to 99.5 mA and the pulse width is between 50-200 microseconds, The TENS will be applied for 20 min 3 sessions/week for 8 weeks, Traditional exercises are passive , active Rom exercises and massage, these exercises are performed for 30 minutes and repeated 2 times daily | Other | Rocabado exercises, Rocabado exercises plus TENS, Transcutaneous electrical nerve stimulation device |
Primary outcome
. Vernier caliper:
Time frame: 8 weeks
The vernier, dial, and digital calipers give a direct reading of the distance measured with high accuracy . Vernier calipers commonly used in industry provide a precision to 0.01 mm (10 micrometres), or one thousandth of an inch. They are available in sizes that can measure up to 1,829 mm (72 in) (Agrawal et al., 2015).
Mandibular Function Impairment Questionnaire:
Time frame: 8 weeks
The Mandibular Function Impairment Questionnaire is used to assess the limitation of oral function due to mandibular function impairment. Subjects will compelete this self-reported questionnaire that comprise 17 items encompassing the difficulty of chewing hard and soft foods, taking large bites, laughing, eating certain foods, engaging in social activity, and speaking. The items are scored on a 5-point Likert scale (0-4). The overall score is calculated by dividing the sum of the item scores by 68, with a possible range of 0 to 1. A higher score denotes a more serious functional impairment. An overall score of ≤0.3 denotes a low degree, 0.3 ≤ 0.6 denotes a moderate degree, and >0.6 denotes a high degree of functional impairment( Stegenga et al.,1993).
1 secondary outcome
Visual Analogue Scale:
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rana elattar, master principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocabado exercises plus TENS device in people with Head and Neck Cancer, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
. Vernier caliper: (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.