ClinicalTrials.gg
Not yet recruitingNCT07056725Updated Jul 9, 2025

Quality of Life and Sleep in Patients With Temporomandibular Disorders

An interventional study of Manual Therapy and Therapeutic Exercises Programs in Temporomandibular Disorders (TMDs), sponsored by University of Jaén. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-09.

Sponsored by University of Jaén · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 40 studies in Temporomandibular Joint Disorders with a site in Spain — 12 open to participants now, 13 under way, none of them phase 3. Temporomandibular Joint Disorders · Spain.

Planned enrollment
27th of 32
30 · median 53
Started
2025
with 4 others
No phase
28 of 40
8 open now
Primary completion
2025-10
later than 3 of 12 live
Registered
36th of 40
by date
Lead sponsor
4 of 40
University of Jaén

Among the 40 studies in Temporomandibular Joint Disorders with a site in Spain, this one is the 27th largest by planned enrollment of the 32 interventional ones, is one of 5 that started in 2025, is one of 28 with no phase, reaches primary completion later than 3 of the 12 other live ones, and was the 36th registered.

By phase

40 studies; the count open now beside each. This study's row is marked.

No phasethis study28 · 8 open
Observational8 · 4 open
Phase 1/22 · 0 open
Phase 2/31 · 0 open
Phase 41 · 0 open

By the year they started

First in 2009; this study’s year is marked. 5 started in 2025.

Size and results

Median enrollment 53 across the 32 interventional studies, 115 across the 8 observational. Of the 23 that completed or were terminated, 3 (13%) have results posted.

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02

Study summary

The aim of this study is to evaluate and compare the effects of two physiotherapeutic intervention programs on the quality of life in patients with Temporomandibular Disorders (TMD).

Study design: Randomized, longitudinal, and prospective clinical trial with two intervention groups.

Population: Subjects aged 18-65 years with subacute temporomandibular disorders.

Read the detailed description

The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. A total of 30 subjects with Temporomandibular Disorders (TMD) will be selected and randomly assigned into two intervention groups.

The first group will receive a physiotherapy treatment based on a Manual Therapy program targeting the orofacial region, combined with a Cervical Therapeutic Exercise program. In contrast, the second group will receive a physiotherapy treatment based on a Manual Therapy program for the orofacial region, combined with an Orofacial Therapeutic Exercise program.

Both groups will undergo a total of six treatment sessions over a period of six weeks (1 session per week). Each manual therapy session targeting the orofacial region will last 30 minutes. The manual therapy (MT) techniques will include a combination of neuromuscular and articular manual techniques.

The study will assess the following variables: quality of life, sleep quality, pressure pain threshold, maximum pain-free mouth opening, perceived pain, and treatment adherence.

Measurements will be taken pre-treatment, post-treatment and a follow-up at 8 weeks

03

Conditions studied

  • Temporomandibular Disorders (TMDs)

Keywords

  • Manual Therapy
  • Therapeutic Exercise
  • Quality of life
  • Quality of Sleep
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults between 18 and 65 years of age with subacute Temporomandibular Disorders (TMD).
  • Diagnosis of TMD based on: The Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). And The Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
  • Willingness to participate in the study and signing of the form.

Exclusion criteria

Exclusion Criteria:

  • Individuals younger than 18 years or older than 65 years.
  • Medical history or systemic conditions, including: Diagnosis of neurological or neuromuscular disorders (such as multiple sclerosis, facial paralysis, trigeminal neuralgia). Systemic or inflammatory joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, fibromyalgia). Presence of severe psychiatric disorders. Previous diagnosis of cancer in the craniofacial or cervical region.
  • Previous interventions (e.g., surgery involving the TMJ or the orofacial and cervical regions).
  • History of trauma in the region, including mandibular trauma, whiplash injuries, or fractures in the area.
  • Pregnant or breastfeeding women.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Group 1

    Subjects in this group will receive physiotherapy treatment consisting of a Manual Therapy program targeting the orofacial region, combined with a Cervical Therapeutic Exercise program. The Cervical Therapeutic Exercise program focuses on co-contraction exercises of the flexor and extensor muscles, progressively increasing difficulty and resistance through the use of a latex band (Theraband), along with neural tissue techniques.

    Other: Manual Therapy and Therapeutic Exercises Programs

  • Experimental
    Group 2

    Subjects in this group will receive physiotherapy treatment consisting of a Manual Therapy program targeting the orofacial region, combined with an Orofacial Therapeutic Exercise program. The Orofacial Therapeutic Exercise program focuses on coordination exercises of the masseter muscles, progressively increasing difficulty and resistance, and is combined with neural tissue techniques.

    Other: Manual Therapy and Therapeutic Exercises Programs

Interventions

  • OtherManual Therapy and Therapeutic Exercises Programs

    A treatment based on the combination of Manual Therapy targeting the orofacial region and a therapeutic exercise program focused on either the cervical or orofacial region

06

What researchers measure

Primary outcomes

  1. Quality of Life (SF-12)

    The SF-12 consists of a subset of 12 items from the SF-36, covering physical functioning, social functioning, physical role, emotional role, mental health, vitality, bodily pain, and general health. The SF-12 is a shortened version of the SF-36 Health Survey. It is a self-administered questionnaire with a completion time of less than 2 minutes. The response options are based on Likert-type scales that assess intensity or frequency. The number of response options ranges from three to six, depending on the item.

    Time frame: Pre-intervention, post-intervention (6 weeks) and follow-up of 8 weeks after the end

  2. Sleep Quality (Pittsburgh Sleep Quality Index)

    The Pittsburgh Sleep Quality Index (PSQI) is a self-administered instrument designed to assess sleep quality in adults over the past month. It consists of 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.

    Time frame: Pre- intervation, post-intervention (6 weeks) and follow-up of 8 weeks after the end.

Secondary outcomes

  1. Pain Intensity (NRS)

    The Numerical Rating Scale (NRS) is a widely used instrument for the subjective assessment of pain intensity. It consists of a numerical scale from 0 to 10, where 0 indicates no pain and 10 represents the highest intensity. Patients select the number that best reflects the severity of their symptom.

    Time frame: Pre- intervention, post- intervention (6 weeks) and follow-up of 8 weeks after the end

  2. Pressure Pain Threshold (PPT)

    The tip of the algometer will be applied perpendicularly to the muscle (anterior portion of the temporalis muscle and the superficial belly of the masseter muscle), and pressure will be gradually increased at a rate of 1 kg/sec. Participants will be instructed to signal the moment they first perceive pain, in order to accurately record the pressure pain threshold.

    Time frame: Pre- intervention, post- interventio (6 weeks) and follow-up of 8 weeks after the end.

  3. Maximum Pain-Free Mouth Opening (MPMO)

    MPMO is a clinical measure used to assess mandibular function in patients with temporomandibular disorders (TMD). This variable evaluates the ability to open the mouth without experiencing pain, reflecting the functional status of the temporomandibular joint and the associated musculoskeletal structures.

    Time frame: Pre- intervention, post- intervention (6 weeks) and follow-up of 8 weeks after the end.

  4. Treatment Adherence

    A personalized diary will be provided for each participant in both groups. Each program will include an exercise log that patients will be required to complete.

    Time frame: Post- intervention (6 weeks)

07

Study locations

1 site
  • Universidad de Alcalá De Henares
    Madrid, Alcalá de Henares 28801, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2025; primary completion for Oct 2025, 2 months later.

Of 242 non-industry interventional studies with no phase under Temporomandibular Joint Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 2 months is below that.

Counting every sponsor, half of 246 studies reached it within 10 months; a quarter within 5 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 28, 2025
First posted
Jul 9, 2025
StartEst.
Aug 2025
Primary completionEst.
Oct 2025
CompletionEst.
Jan 2026
Last update
Jul 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07056725
Lead sponsor
University of Jaén
Responsible party
Alexander Achalandabaso (Clinical Professor, University of Jaén) — Principal investigator
First posted
Jul 9, 2025
Start date
Aug 2025 (estimated)
Primary completion
Oct 2025 (estimated)
Completion
Jan 2026 (estimated)
Last update
Jul 9, 2025

Study contacts

Jaime Martínez Barros
Contact
fisiojmb@gmail.com
+ 34 686052159

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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