How is Aerobic Exercise Compared to Localized Pain Relief Exercises in Patients With Jaw Pain and Neck Pain?

NCT05232604 | Recruiting DMC

• 1 other identifier: HSOS/2020/2/1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Musculoskeletal (MSK) disorders are some of the most burdensome health issues in the world and the leading causes of years living with a disability. Between them, jaw pain and neck have been very prevalent among the general population. Subjects with chronic neck and jaw pain present with persistent pain, allodynia, and hyperalgesia, sometimes extending to regions distant from the neck, head, or face, as well as cognitive and motor dysfunction. In addition, both conditions are commonly related to pain in other anatomical regions, and they also might also exhibit a greater risk for pain-associated somatic symptom burden. The treatment for patients with neck and jaw could involve different techniques in the rehabilitation area. Between them, therapeutic exercise is a cornerstone of MSK disease rehabilitation. Although mechanisms of action for exercise in subjects with pain are not yet understood, therapeutic exercise is widely applied in a variety of painful MSK conditions, such as low back pain, shoulder pain, knee pain, osteoarthritis, and disorders of the cervical and craniofacial regions such as temporomandibular disorders, headaches, and neck pain. Besides its effects on function and health, therapeutic exercise is known to have some pain-relieving effects and specific motor control exercises targeted to the neck can enhance the neural control of the cervical spine in patients with neck involvement such as patients with jaw and neck pain. Previous studies have demonstrated that treatment directed to the neck may be beneficial in decreasing pain intensity in the masticatory muscles, increasing pain-free mouth opening, and decreasing pain in the head and neck regions in people with jaw pain. In addition, neck motor control exercises have been successful to manage chronic neck pain and cervicogenic headache. Subjects with neck pain and associated disorders receiving neck motor control exercises had a reduction of pain and improved quality of life. Another option that has been explored to relieve MSK pain is aerobic exercise. Aerobic exercise has been used to stimulate the release of pain-relieving peptides in healthy human beings; however, little is known about the analgesic effect of exercise in people suffering from actual musculoskeletal pain. Previous literature found positive results in favor of aerobic exercise for pain relief. However, none of them included patients with jaw and neck-related disorders. Therefore, the aim of the present pilot randomized controlled trial (RCT) is to test the effectiveness of local craniocervical motor control exercises when compared with aerobic exercise on pain-disability related outcomes such as pain intensity, pain pressure thresholds (PPTs), jaw and neck disabilities and to restore normal muscular performance and fatigability of the cervical muscles in people with jaw and neck pain. Also, an important objective for performing this pilot study is to test the feasibility of these protocols and gather data that will be the basis for applying to external funding. This study will be a randomized controlled trial, blinded, two-armed parallel group. It will include women between 18-60 years of age; diagnosed with temporomandibular disorders (i.e., jaw pain) classified by the new Diagnostic Criteria for Temporomandibular Disorders (DC/TMD); or diagnosed with idiopathic chronic neck pain associated or not with TMD. Because this is an exploratory (pilot) study it will include at least 21 subjects per treatment group. The primary outcome will be pain intensity evaluated by the Visual Analogue Scale (VAS), and the secondary outcomes will be Neck Disability Index; Jaw Function; Pressure Pain Threshold; Psychological functioning; Global Rating Scale; and Muscular performance and fatigability of the cervical muscles. The patients will be randomized into two groups: local craniocervical motor control exercises and aerobic exercise. The local craniocervical motor control exercises program will be focused on training the deep and superficial flexors and extensors neck muscles. The treatment will consist of a 12-week progressive training program with a total duration of 30-45 min per session. Individuals assigned to the aerobic exercise will receive cycling exercise, with a total duration of 60 minutes. Both groups will be evaluated before the treatment starts (baseline); after two and six weeks from the beginning of treatment (1st and 2nd partial evaluation); at the end of the treatment (final evaluation - 12 weeks); and after three and six months of the end of the treatment (1st and 2nd follow-up).

Conditions

Temporomandibular Disorder; Neck Pain

Keywords

Temporomandibular disorder; Neck pain; Exercise therapy; Motor control exercise

Outcome Measures

Primary Outcomes (1)

• Pain - Visual Analog Scale (mean change at 12 weeks)

  A change in pain intensity (measured with the VAS) from baseline to end of treatment (12 weeks) for both groups. The pain evaluated will be the pain related to the patient's main complaint, i.e. jaw pain or neck pain. The VAS is a 100 mm linear scale, labeled with the two extreme boundaries of pain sensation: "no pain" at one end (0 mm) and "worst pain imaginable" at the other end (100 mm). The VAS has demonstrated validity and reliability to measure the intensity of pain and it is heavily used in people with neck pain as well as jaw pain research. The VAS varies from 0 to 100 mm, and the higher values means worse results.

  Main Outcome is pain change at 12 weeks. Other time points will also be collected (baseline, 2, 6 weeks after the beginning of treatment, final evaluation (12 weeks after the beginning of treatment), three and six months after the end of treatment

Secondary Outcomes (2)

• Neck Disability Index

  baseline, 2, 6 weeks after the beginning of treatment, final evaluation (12 weeks after the beginning of treatment), three and six months after the end of treatment

• Jaw function scale

  baseline, 6 weeks after the beginning of treatment, final evaluation (12 weeks after the beginning of treatment), three and six months after the end of treatment

Other Outcomes (22)

• Mouth range of motion

  baseline, final evaluation (12 weeks after the beginning of treatment), three and six months after the end of treatment

• Upper and global Neck range of motion

  baseline, 6 weeks after the beginning of treatment, final evaluation (12 weeks after the beginning of treatment), three and six months after the end of treatment

• Pressure pain threshold

  baseline, final evaluation (12 weeks after the beginning of treatment), three and six months after the end of treatment

Study Arms (2)

Aerobic exercise group (AE)

EXPERIMENTAL

The session training will be divided into a warm-up, main exercise period, and cool-down, with a total duration of 60 minutes (guided by a PT). The training will be performed on a cycle ergometer, three times per week for 12 weeks. The duration of the main AE will be between 30-45 minutes and the intensity will be based on the maximal heart rate (HRmax), heart rate reserve (HRR), and the Borg Rating of Perceived Exertion Scale (Borg Scale), which will be monitored. The intensity of the AE program will be progressively increased according to each patient's response and tolerance but will be standardized as much as possible: 1) first two weeks, low to moderate intensity (60% HRmax or 9-11 on the Borg scale); 2) 2-6 weeks, moderate-intensity (55-70% HRmax or 12-14 on the Borg scale), and 3) last 6 weeks, high intensity interval training (HIT) (75-90% HRmax or 15-17 on the Borg scale; 4 min\*4 times HIT followed by 3 min of 70%HRmax in between) will be targeted per literature endorsements.

Other: Aerobic exercise

Neck motor control exercise group

ACTIVE COMPARATOR

The treatment will consist of a 12-week progressive exercise program targeted to the neck flexor and extensor muscles supervised by a physical therapist (PT). This exercise protocol has been successfully tested in subjects with NP. Low load craniocervical exercises (nodding) will be performed at early stages (first 6 weeks) guided by visual feedback from a pressure unit. Higher-load neck exercises will be performed at later stages (last 6 weeks). During the first month, subjects will receive 30-45 min of MCTF three times per week, in the second month twice per week, and in the third month once per week. This duration of treatment is commonly used in clinical settings and has proven to be sufficient to improve muscle function, clinical, and brain outcomes.

Other: Neck motor control exercise

Interventions

Aerobic exercise OTHER

30-45 minutes of aerobic exercise in a cycle ergometer will be applied in three different intensities (low, moderate and high) along 12 weeks of treatment.

Aerobic exercise group (AE)

Neck motor control exercise OTHER

An specific neck motor control exercise targeted to the neck flexor and extensor muscles supervised by a physical therapist will be applied during 12 weeks of treatment.

Neck motor control exercise group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be between 18-60 years of age
• Be diagnosed with idiopathic chronic neck pain as described the IASP and/or presence of temporomandibular disorders identified by DC/TMD screening
• Have pain in the neck or jaw area for at least 3 months (chronic pain)
• Have pain not attributable to recent acute trauma, previous infection, or to an active inflammatory cause in the last month
• Have a moderate or severe baseline pain score of 30mm or greater using a 100mm VAS

You may not qualify if:

• Present red flags for serious pathologies related to neck pain or jaw pain
• Report comorbidity functional chronic pain disorders (e.g., fibromyalgia)
• Have been diagnosed with psychiatric disorders (e.g., depression, schizophrenia)
• Have received therapy within 3 months prior to entry into the study

Sponsors & Collaborators

• Hochschule Osnabruck: lead

Study Sites (1)

Hochschule Osnabrück - University of Applied Sciences

Osnabrück, Lower Saxony, 49076, Germany

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Neck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Susan Armijo-Olivo, PhD Professor

CONTACT

+49 1522 3170807; susanarmijo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessors (assessing clinician assessed outcomes) and the statistician will be blinded to group allocation. Participants will be unaware of the hypothesis of this study to decrease performance biases.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups (aerobic exercise group and neck motor control exercise group) will receive the protocol at the same time period.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: February 10, 2022
• Study Start: October 7, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

DE (1)