Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06365151
Other study ID # TMDs fibromyalgia
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 5, 2024
Est. completion date April 5, 2026

Study information

Verified date May 2024
Source Universitat de Lleida
Contact Llanos de la Iglesia, MsC
Phone +4679536992
Email llanos.delaiglesia@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Nowadays, fibromyalgia is the rheumatic disorder with the highest levels of deterioration in quality of life. Among the comorbidities it presents, one of the most frequent is temporomandibular disorders. A randomized clinical study will be conducted to evaluate the effectiveness of an osteopathic manual therapy approach algorithm in a group of patients with fibromyalgia and temporomandibular disorders.


Recruitment information / eligibility

Status Recruiting
Enrollment 114
Est. completion date April 5, 2026
Est. primary completion date April 5, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - be diagnosed as suffering from fibromyalgia, - present moderate pain or dysfunction of more than 3 months' duration in the temporomandibular joint, - be over 18 years old, - understand Spanish and/or Catalan correctly, - and read and accept the informed consent form Exclusion Criteria: - history of trauma or recent surgery to the head, face or neck; - systemic, rheumatic or central nervous system diseases; - diagnosis of malignant tumors or cancer in the orofacial region; - participate in other studies at the same time.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Osteopathic manual therapy
osteopathic manual treatment aimed at improving the function and pain of the temporomandibular joint.
Sham osteopathic manual therapy
a sham osteopathic manual treatment without therapeutic effect

Locations

Country Name City State
Spain Osteopatia i Fisioteràpia Cornellà Cornella de Llobregat Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Universitat de Lleida

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary catastrophizing The Pain Catastrophizing scale (PCS), evaluates the degree og catastrophic thinking gdue to pain.It is a 13-item scale, with a total range from 0 to 52. Higher scores are associated with a greater degree of pain catastrophizing. week 1, week 4, week 6
Primary functional limitation evaluated with tue short version of the Jaw functional limitation scale (JFLS-8). Evaluates the functional status of the masticatory system. Questionnaire with 8 items, each with a scale from 0 to 10. A higher score suggests a greater limitation. week 1, week 4, week 6
Primary functional status, disability and pain collected in the craniofacial pain and disability inventory (CFPDI). Self administered questionnaire of 21 items. Each item is scored on a Likert scale from 0 to 3. week 1, week 4, week 6
Primary pain and tinnitus evaluated with a visual analog scale (VAS). Scale from 0 to 10, where 0 indicates no pain and 10 the worst pain imaginable. week 1, week 4, week 6
Primary myofascial trigger points presence of a palpable tight band, presence of a hyperirritable tenderpoint within te tight band, local twitch response elicited by acute palpation of the tight band, and presence refered pain in response ot trigger point compression. week 1, week 4, week 6
Primary Range of motion measurements taken with a ruler: maximum opening, maximun active opening without pain and lateralization. week 1, week 4, week 6
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05659862 - Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT03042728 - Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program N/A
Recruiting NCT06097091 - Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia N/A
Recruiting NCT04554784 - Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia N/A
Completed NCT03300635 - Metabolism, Muscle Function and Psychological Factors in Fibromyalgia N/A
Recruiting NCT06166563 - Exercise, Irritable Bowel Syndrome and Fibromyalgia N/A
Completed NCT03227952 - Sensory Stimulation in Fibromyalgia N/A
Completed NCT03166995 - Postural Exercises in Women With Fibromyalgia N/A
Recruiting NCT06237595 - Vagus Nerve Stimulation in Fibromyalgia N/A
Completed NCT01888640 - Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST) N/A
Completed NCT03641495 - Pain Education and Therapeutic Exercise for Fibromyalgia N/A
Recruiting NCT05581628 - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Active, not recruiting NCT05128162 - Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia Phase 2
Completed NCT04674878 - Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia N/A
Active, not recruiting NCT04084795 - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia N/A
Completed NCT03129906 - Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients N/A
Completed NCT05058911 - Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia N/A
Recruiting NCT04571528 - Effectiveness of VIRTUAL FIBROWALK STUDY N/A
Recruiting NCT04571853 - New Educational Tool for FM N/A