Home Exercises Program Compared With Physiotherapy Program in TMD

NCT05778890 | Completed

• 1 other identifier: Nigdeohu-ZHMYO-GPT-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Although there are physiotherapy programs that are widely used in the treatment of Temporomandibular Disorders (TMD), there are few studies investigating the effects of home exercises program specifically developed for TMD. Aim: Investigators aimed to investigate the effect of home exercise program on pain and quality of life in TMD treatment. Methods: 20 patients were included in our pilot study and were randomised into two groups. Home exercises program and physiotherapy program were applied to the intervention group (n=10; age 31.4±11.2 years), and only physiotherapy program to the control group (n=10, age 35.3±18.1 years). Physiotherapy program included ultrasound (US), Transcutaneous Electrical Nerve Stimulation (TENS) and exercise. Investigators measured pain with the Visual Analogue Scale (VAS) and quality of life with the Short Form 36 (SF-36) before and after the treatment.

Conditions

Temporomandibular Disorder

Keywords

temporomandibular joint disorders; pain; quality of life; exercises

Outcome Measures

Primary Outcomes (1)

• Pain. Visual Analogue Scale (VAS)

  It was questioned whether each patient had pain in the head, neck, shoulder, lower back, jaw, teeth and back for the last 6 and the patients were asked to mark the severity of the existing pain on a 10 cm chart weeks (0=no pain, 10= worst imaginable pain). Then, these points were evaluated by measuring with a ruler.

  3 weeks

Secondary Outcomes (1)

• Quality of Life. SF-36 Quality of Life Questionnaire

  3 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

The physiotherapy program consisted of 1 session per day for 3 weeks, a total of 15 sessions. Intervention group included Ultrasound for 5 minutes to both TMJ, TENS on both TMJ for 20 minutes, exercise for 30 minutes and patient education. The intervention group was also taught home exercises program and asked to do 6 repetitions 6 times a day. This exercise program was given to the patients in brochure form. These exercises were not given to the control group.

Other: Intervention Group: Physiotherapy program + home exercises program

control group

ACTIVE COMPARATOR

Control group is physiotherapy program consisted of 1 session per day for 3 weeks, a total of 15 sessions. This group included Ultrasound for 5 minutes to both TMJ, TENS on both TMJ for 20 minutes, exercise for 30 minutes and patient education.

Other: Control Group : Physiotherapy program

Interventions

Intervention Group: Physiotherapy program + home exercises program OTHER

Physiotherapy program: The physiotherapy program consisted of 1 session per day for 3 weeks, a total of 15 sessions. Treatment for control group included Ultrasound for 5 minutes to both TMJ, TENS on both TMJ for 20 minutes, exercise for 30 minutes and patient education. In addition to the treatment for control group, intervention group received home exercises program.The intervention group was also taught home exercises program and asked to do 6 repetitions 6 times a day. This exercise program was given to the patients in brochure form.

Intervention group

Control Group : Physiotherapy program OTHER

Physiotherapy program: The physiotherapy program consisted of 1 session per day for 3 weeks, a total of 15 sessions. Treatment for control group included Ultrasound for 5 minutes to both TMJ, TENS on both TMJ for 20 minutes, exercise for 30 minutes and patient education.

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a clinical and radiological diagnosis for TMD,
• Age between 18-65
• having TMJ pain for at least 3 months

You may not qualify if:

• Having an inflammatory connective tissue disease such as rheumatoid arthritis,
• Malignant tumor involving the craniocervical region,
• Heart conditions or using a pacemaker,
• Pregnancy
• Receiving any treatment for TMJ within the last 2 years (including surgery, orthotics, physical therapy).

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Niğde Ömer Halisdemir University Bor Physical Therapy Hospital

Niğde, 51100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Pain; Motor Activity

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Gül PEHLİVAN TEKİN

  Niğde Bor Physical Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Twenty patients were divided into two groups of ten each with randomisation (closed envelope method). outcomes assessor was blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 20 patients were included in our pilot study and were randomised into two groups. Traditional physiotherapy program and home exercises program were applied to the intervention group (n=10; age 31.4±11.2 years), and only traditional physiotherapy to the control group (n=10, age 35.3±18.1 years). Traditional physiotherapy program included ultrasound (US), TENS and exercise.

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 21, 2023
• Study Start: July 10, 2017
• Primary Completion: February 20, 2018
• Study Completion: May 2, 2018
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)