CClinicalTrials.gg
CompletedNCT07151469Updated Feb 12, 2026

Kaltenborn Versus Active Release on Temporomandibular Joint Dysfunction

An interventional study of Kaltenborn mobilization and active release technique in Head and Neck Cancer, sponsored by MTI University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by MTI University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
115
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

KMT evaluates the motions on the articular surfaces and applies them to treatment according to MacConaill's classification of synovial joints to restore the reduced accessory glides and achieve painless physiological movements. KMT involves the application of a passive sustained joint play that can be graded from I to III based on the type and amount of force applied. Grade-I, "loosening" refers to small-amplitude joint distraction that produces an appreciable increase in joint separation without any stress on the capsule that equalizes the cohesive forces, muscle tension and atmospheric pressure acting on the joint. Grade-II, "tightening" refers to the distraction or glide movements applied to tighten the tissues around the joint, also known as "taking up the slack". Grade-III, "stretching" refers to the distraction or glide movement applied to stretch the joint capsule and surrounding per articular structures, thus, increasing joint ROM.

Another option to consider is offered here at Pain and Performance Solutions. We have seen great results from treating TMJ disorders using Active Release Technique®. 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 a very effective method for treating TMD.

02

Conditions studied

  • Head and Neck Cancer
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's enrollment of 115 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

MTI University is the lead sponsor of 58 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.
  • 6 months after ending radiotherapy.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
115 participants (actual)

Study arms

  • Experimental
    Kaltenborn mobilization

    A 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.

    Other: Kaltenborn mobilization

  • Experimental
    active release technique

    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

    Other: active release technique

  • No intervention
    control

    No intervention

Interventions

  • OtherKaltenborn mobilization

    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

  • Otheractive release technique

    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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: at baseline and at 8 weeks

  2. 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

    Time frame: at baseline and at 8 weeks

Secondary outcomes

  1. Functional disability

    It will be measured by jaw functional limitation scale-20. It has a score range of 1 to 200, and high scores indicate worsening jaw function.

    Time frame: at baseline and at 8 weeks

  2. Quality of life (Oral health Impact Profile

    By using the Oral health, Impact Profile consisted of 7 different domains (functional limitation, physical pain, psychological discomfort, psychological disability, physical disability, social disability, and handicap).a 5-point Likert scale (zero = never to four = very often). A summing of the domain scores derived the total score; it can range from zero to 56. A higher score indicates a poorer quality of life.

    Time frame: at baseline and at 8 weeks

07

Study locations

1 site
  • faculty of physical therapy ,Cairo University
    Cairo, 3753450, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07151469
Lead sponsor
MTI University
Responsible party
Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d (Assisstant professor, MTI University) — Principal investigator
First posted
Sep 3, 2025
Start date
Oct 1, 2025
Primary completion
Feb 1, 2026
Completion
Feb 10, 2026
Last update
Feb 12, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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