Diacutaneus Fibrolysis on Tempromandibular Joint Pain and Trismus Post Oral Surgery

NCT06675149 | Completed

• 1 other identifier: 012/005335
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• temporomandibular joint pain

  pain is assessed Pressure pain threshold(PPT) will be obtained with the aid of an algometer by applying pressure to the masseter and to the anterior, middle, and posterior temporalis, increasing pressure until the patient will feel that the pressure will become unpleasant or "painful .

  pre intervention and re assessed after 1 month

• Trismus

  Trismus is assessed by caliper

  pre intervention and re assessed after 1 month

Study Arms (2)

Group B

EXPERIMENTAL

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

Device: Diacutaneus fibrolysis; Device: Transcutaneous electrical nerve stimulation; Procedure: Massage

Group A

PLACEBO COMPARATOR

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

Device: Transcutaneous electrical nerve stimulation; Procedure: Massage

Interventions

Diacutaneus fibrolysis DEVICE

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

Also known as: Hook measurements

Group B

Transcutaneous electrical nerve stimulation DEVICE

physical therapy electrical modality

Also known as: TENS

Group A; Group B

Massage PROCEDURE

manual therapy intervention

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages of patients will be ranged from 18 to 40 years.
• All patients will have Oral and Maxillofacial Surgery.
• All patients will be referred by a surgeon before starting the study procedure.
• All participants will have pain and trismus in the jaw,
• The participants will be also cleared for periodontal issues.
• All patients will enter the study having their informed consent

You may not qualify if:

• Patients with associated vascular injuries requiring arterial repair.
• Patient with systemic diseases such as arthritis; pain attributable to confirmed migraine, head, or neck pain condition
• Patient with acute infection or other significant disease of the teeth, ears, eyes, nose, or throat
• Patient with present neurologic or cognitive deficit.
• Patients with history of previously failed surgeries.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, 12613, Egypt

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation; Massage

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: August 20, 2024
• Primary Completion: September 20, 2024
• Study Completion: February 27, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

EG (1)