Effects of Radial Shock Wave Therapy in the Treatment of Temporomandibular Joint Syndrome.

NCT04477122 | Completed

• 1 other identifier: UJaen Posture
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the effects of radial shock wave therapy in the treatment of temporomandibular joint syndrome. For this objective, subjects recruited will be allocated in an experimental group or a placebo group. Both groups will receive one manual therapy and radial shock waves therapy (real for experimental group, a sham device for placebo group) session per week along one month. Pain, neck function and quality of life measured will be performed before the intervention, after the last treatment and at one month follow-up.

Conditions

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Keywords

temporomandibular joint; temporomandibular joint syndrome; temporomandibular joint dysfunction; extracorporeal shock waves

Outcome Measures

Primary Outcomes (6)

• Temporomandibular joint pain

  Actual local pain at temporomandibular joint measured with Numerical pain rating scale

  Baseline

• Temporomandibular joint pain

  Actual local pain at temporomandibular joint measured with Numerical pain rating scale

  At one month

• Temporomandibular joint pain Temporomandibular joint pain

  Actual local pain at temporomandibular joint measured with Numerical pain rating scale

  At two months

• Neck function

  Neck Disability Index, a 10 questions scale about neck function

  Baseline

• Neck function

  Neck Disability Index, a 10 questions scale about neck function

  At one month

• Neck function

  Neck Disability Index, a 10 questions scale about neck function

  At two months

Secondary Outcomes (18)

• Pain threshold

  Baseline

• Pain threshold

  At one month

• Pain threshold

  At two months

• Headache impact in quality of life

  Baseline

• Headache impact in quality of life

  At one month

Study Arms (2)

Blue

EXPERIMENTAL

Four sessions (one per week along one month) of manual therapy (25 minutes of massage on temporal, masseter and pterygoid muscles and 5 minutes of joint passive mobilization) and 3 minutes (2000 shots approximately) of extracorporeal radial shock waves therapy on painful points of masseter and temporal muscles at 2 bars and 10 Hertzs. Participants will wear splint 23 hours/day

Other: Manual therapy and extracorporeal radial shock waves therapy

Red

PLACEBO COMPARATOR

Four sessions (one per week along one month) of manual therapy (25 minutes of massage on temporal, masseter and pterygoid muscles and 5 minutes of joint passive mobilization) and 3 minutes of placebo extracorporeal radial shock waves therapy on painful points of masseter and temporal muscles. Participants will wear splint 23 hours/day

Other: Manual therapy and extracorporeal radial shock waves therapy

Interventions

Manual therapy and extracorporeal radial shock waves therapy OTHER

25 minutes of manual therapy, 5 minutes of temporomandibular joint mobilization and 3 minutes of extracorporeal radial shock waves therapy (real or placebo)

Blue; Red

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed of temporomandibular disorder by medical doctor.

You may not qualify if:

• Subjects who due to their own characteristics are not able to carry out the study tests

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Clinica Fisiomedic

Seville, 41000, Spain

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Myofascial Pain Syndromes

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will take and opaque enveloped who revealed the allocation group (named as RED or BLUE for blindness conditions). Investigators will not be aware of the which device is sham or real treatment due to codification. The outcomes assessor will be a different person from the investigator and the care providers, unaware of group allocation and treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Sciences Department Professor

Model Details: Two groups: experimental one and placebo group, receiving the intervention at the same time

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 20, 2020
• Study Start: October 27, 2020
• Primary Completion: December 29, 2020
• Study Completion: January 25, 2021
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)