Diacutaneus Fibrolysis on Tempromandibular Joint Pain and Trismus Post Oral Surgery

NCT ID: NCT06675149

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-20
• Study Completion Date: 2025-02-27

Brief Summary

This study is carried out on sixty patients who will have tempromandibular pain and trismuspostOral and Maxillofacial Surgeryand their ages will be ranged from 18 to 40 years.

Conditions

Temporomandibular Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group B

This group includes 30 patients who will receive 4 weeks(3times/week) DiacutaneusFibrolysis in addition to post-surgical traditional physiotherapy .

Group Type: EXPERIMENTAL

Diacutaneus fibrolysis

Intervention Type: DEVICE

Material : Stainless steel large angle and small long angle: length 22cm x height 6cm x width 2cm. Weight: 70 grams

Transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

physical therapy electrical modality

Massage

Intervention Type: PROCEDURE

manual therapy intervention

Group A

This group will includes 30 patients who will receive 4 weeks (3times/week) post-surgical traditional physiotherapy (TENS , massage , range of motion exercise ) .

Group Type: PLACEBO_COMPARATOR

Transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

physical therapy electrical modality

Massage

Intervention Type: PROCEDURE

manual therapy intervention

Interventions

Diacutaneus fibrolysis

Material : Stainless steel large angle and small long angle: length 22cm x height 6cm x width 2cm. Weight: 70 grams

Intervention Type: DEVICE

Transcutaneous electrical nerve stimulation

physical therapy electrical modality

Intervention Type: DEVICE

Massage

manual therapy intervention

Intervention Type: PROCEDURE

Other Intervention Names

Hook measurements; TENS

Eligibility Criteria

Inclusion Criteria

1. Ages of patients will be ranged from 18 to 40 years.

2. All patients will have Oral and Maxillofacial Surgery.

3. All patients will be referred by a surgeon before starting the study procedure.

4. All participants will have pain and trismus in the jaw,

5. The participants will be also cleared for periodontal issues.

6. All patients will enter the study having their informed consent

Exclusion Criteria

1. Patients with associated vascular injuries requiring arterial repair.

2. Patient with systemic diseases such as arthritis; pain attributable to confirmed migraine, head, or neck pain condition

3. Patient with acute infection or other significant disease of the teeth, ears, eyes, nose, or throat

4. Patient with present neurologic or cognitive deficit.

5. Patients with history of previously failed surgeries.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aliaa Elsayed Ali

Demonstrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

012/005335

Identifier Type: -

Identifier Source: org_study_id