An Internet-based Multimodal Pain Program for Chronic Temporomandibular Disorder Pain

NCT04363762 | Completed

• 1 other identifier: OSK2016OFRS01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background Chronic temporomandibular disorders (TMD) pain is an undertreated condition in Sweden despite the fact that national guidelines includes effective treatment options. These guidelines recommend multimodal treatment with a behavioral approach. Internet-based intervention is an appealing modality for multimodal TMD treatment, enabling more patients to be reached and treated. Objective To investigate the treatment effect of an internet-based multimodal pain program (iMPP) on chronic TMD pain. As the study progressed, it also became a measure to evaluate the feasibility of running a larger randomized controlled trial.

Conditions

Chronic Pain; Temporomandibular Disorder

Outcome Measures

Primary Outcomes (2)

• Change in The Graded Chronic Pain Scale

  Measures specific to TMD were used as outcome measures, as guided by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations on core domains {Turk, 2003 #300}{Haythornthwaite, 2010 #301}. Primary outcomes included characteristic pain intensity as assessed by the Graded Chronic Pain Scale

  3 months and 6 months follow-ups

• Change in Pain-related disability

  Measures specific to TMD were used as outcome measures, as guided by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations on core domains {Turk, 2003 #300}{Haythornthwaite, 2010 #301}. Primary outcomes included pain-related disability assessed bi the Graded Chronic Pain Scale.

  3 months and 6 months follow-ups

Secondary Outcomes (4)

• Depression

  3 months and 6 months follow-ups

• Anxiety

  3 months and 6 months follow-ups

• Catastrophizing

  3 months and 6 months follow-ups

• The Patient Stress Scale-10

  3 months and 6 months follow-ups

Study Arms (2)

Internet-based multimodal pain program

EXPERIMENTAL

The iMPP is based on CBT and self-management principles that help patient cope with chronic TMD pain. The iMPP translates a face-to-face therapy to a software platform program.

Behavioral: Internet-based multimodal pain program

Occlusal splint

ACTIVE COMPARATOR

Participants randomized to active control received a hard Michigan-type stabilization splint placed in the upper jaw by one of two calibrated general dentists {Ramfjord, 1994 #276}. The occlusal splint was chosen as the control treatment because it is a conventional and reversible treatment of TMD pain, and it has a known moderate efficacy {Welfare, 2011 #266}.

Device: Occlusal splint

Interventions

Internet-based multimodal pain program BEHAVIORAL

A guided internet-based multimodal pain program for chronic TMD pain

Also known as: Internet-based cognitive behavioral program

Internet-based multimodal pain program

Occlusal splint DEVICE

Occlusal splint, standard

Also known as: Michigan splint

Occlusal splint

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 75 years
• at least one of the TMD pain diagnoses myalgia, myofascial pain with referral, headache attributed to TMD, or arthralgia according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) {Schiffman, 2014 #4}
• chronic TMD pain (≥3 months), experienced once a week or more often, with an intensity of ≥3 on an 0-10 numeric rating scale (NRS)
• access to a computer with an internet connection and a mobile phone
• sufficient computer literacy and (6) mastery of the Swedish language

You may not qualify if:

• chronic inflammatory systemic disease
• all psychiatric disorders except depression and anxiety (due to high comorbidity)
• occlusal splint therapy in the past 12 months
• ongoing extensive dental treatment; and (5) conditions contradicting MRI examination.

Sponsors & Collaborators

• Malmö University: lead

Related Publications (1)

• Lam J, Svensson P, Alstergren P. Internet-Based Multimodal Pain Program With Telephone Support for Adults With Chronic Temporomandibular Disorder Pain: Randomized Controlled Pilot Trial. J Med Internet Res. 2020 Oct 13;22(10):e22326. doi: 10.2196/22326.

  PMID: 33048053 DERIVED

MeSH Terms

Conditions

Chronic Pain; Temporomandibular Joint Disorders

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Per Alstergren, Professor

  Malmo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The two interventions compared in this study were not possible to blind for the care provider or the patients. Outcome assessment was based on questionnaires why blinding was not considered necessary, although the investigator and outcomes assessor can be regarded as blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Senior Consultant, Pro Dean

Model Details: An unblinded parallel-arm RCT pilot study with equal allocation was conducted. Participants were randomized to the iMPP or to an active control. They were recruited from a general dental care clinic (Fäladstorget) within the National Dental Care Skåne, Sweden. Examination and allocated treatment were free of charge for participants, and no other financial compensation was given. This study is part of a large research project with the primary objective to study changes in the brain after treatment in patients with chronic TMD pain. Therefore, participants went through magnetic resonance imaging (MRI) of the brain pre- and post-treatment. Results from neuroimaging data will be presented elsewhere, however, the feasibility of this additional examination will be addressed here. The study was approved by the Ethics Review Board in Lund, Sweden (No. 2016/6).

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 27, 2020
• Study Start: April 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share