Kaltenborn Versus Active Release on Temporomandibular Joint Dysfunction
Kaltenborn Mobilization Versus Active Release Technique on Temporomandibular Joint Dysfunction for Radiation - Induced Trismus in Patients With Head and Neck Cancer
1 other identifier
interventional
115
1 country
1
Brief Summary
Temporomandibular disorder (TMD) is a term describing musculoskeletal conditions of the face, jaw and temporal regions. TMD is frequently associated with pain and/or dysfunction such as impaired jaw function, pain in the temporomandibular joint (TMJ), muscles and/or related structures, and associated headaches. The etiology of TMD is multifactorial and complex. It is known that one cause of TMD symptom development is treatment for head and neck cancer (HNC). The main treatment modalities for HNC include radiotherapy (RT) with or without chemotherapy and surgical intervention, as either a single therapy or a combination therapy. In the head and neck region, the anatomical structures are necessary for essential functions such as speech, swallowing, breathing, smell, and taste. The treatment of head and neck tumors may frequently impair some of these functions, which may result in pain, oral dysfunction, and impaired health-related quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable head-and-neck-cancer
Started Oct 2025
Shorter than P25 for not_applicable head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2025
CompletedFirst Posted
Study publicly available on registry
September 3, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2026
CompletedFebruary 12, 2026
February 1, 2026
4 months
August 25, 2025
February 11, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Pain pressure threshold
The pain pressure threshold over the temporalis and masseter muscles will be assessed using an algometry with a 1 cm2 probe tip.lower thresholds indicating increased tenderness and sensitivity
at baseline and at 8 weeks
Maximal interincisal opening
The stainless steel vernier caliper, which has two arms-one fixed and one movable-connected by a calibrated scale, showed exceptional reliability for measuring mouth opening.Millimeters were used to measure the separation between the incisal edges of the upper and lower incisor teeth
at baseline and at 8 weeks
Secondary Outcomes (2)
Functional disability
at baseline and at 8 weeks
Quality of life (Oral health Impact Profile
at baseline and at 8 weeks
Study Arms (3)
Kaltenborn mobilization
EXPERIMENTALA certified therapist administered TMJ KM in the following way. The therapist stood behind the seated patient, placing their palms on both sides of the patient's head, with the thumbs over the zygomatic arches, to stabilize the head.
active release technique
EXPERIMENTALThis deep tissue therapy technique is primarily used to break up adhesions and scar tissue on the surrounding muscle and ligaments. However, this technique has been proven to be a very effective method for treating TMD
control
NO INTERVENTIONNo intervention
Interventions
The therapist applies gentle traction to the mandible, maintained for approximately 20 to 30 seconds, to create space in the joint. This is done by pulling the jaw downward and slightly forward, which can help alleviate pressure and pain. This hand placement allowed the therapist to apply transverse force across the mandible as necessary, while at the same time allowing an anterior-inferior gliding force to the mandible on the side of restriction, while also controlling the unrestricted side inhibiting any excessive mandibular forward gliding with the other hand. The mobilization is then initiated with Grade I, which involves small-amplitude movements performed at the beginning of the range of joint play to reduce pain and muscle guarding. This is followed by Grade II mobilization, which consists of larger amplitude movements within the mid-range of joint play to enhance joint mobility and decrease pain without reaching the joint's full resistance barrier
This deep tissue therapy technique is primarily used to break up adhesions and scar tissue on the surrounding muscle and ligaments. However, this technique has been proven to be a very effective method for treating TMD.While there are several muscles connected with the movement of the TMJ, it is thought that the major players are the digastricus, masseter, and lateral pterygoid muscles
Eligibility Criteria
You may qualify if:
- An experienced oral and maxillofacial surgeon will diagnose patients with temporomandibular joint disorders (myofascial pain, trismus and limitation of ROM) after head and neck cancer, patients.
- Patients with 20 to 60 years old.
- months after ending radiotherapy.
You may not qualify if:
- Patients with implants.
- Current metastasis.
- Continuing radiotherapy.
- Pregnant females.
- Sensitivity to phototherapy.
- Bell's palsy.
- Subjects with disk displacement, arthralgia or osteoarthritis at TMJ.
- Subjects who received analgesics or antidepressants.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MTI Universitylead
Study Sites (1)
faculty of physical therapy ,Cairo University
Cairo, 3753450, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant professor
Study Record Dates
First Submitted
August 25, 2025
First Posted
September 3, 2025
Study Start
October 1, 2025
Primary Completion
February 1, 2026
Study Completion
February 10, 2026
Last Updated
February 12, 2026
Record last verified: 2026-02