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临床试验/NCT04363762
NCT04363762已完成不适用

An Internet-based Multimodal Pain Program With Telephone Support for Adults With Chronic Temporomandibular Disorder Pain: Pilot Randomized Controlled Trial

Malmö University0 个研究点目标入组 40 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
主要终点
Change in The Graded Chronic Pain Scale

研究概览

简要总结

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.

详细描述

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.

STUDY DESIGN 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. The study was approved by the Ethics Review Board in Lund, Sweden (No. 2016/6). This study was not registered in a public trials registry due to its feasibility character.

PARTICIPANTS Participants had to fulfill the following criteria: (1) age between 18 and 75 years; (2) 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}; (3) 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); (4) access to a computer with an internet connection and a mobile phone; (5) sufficient computer literacy and (6) mastery of the Swedish language. Exclusion criteria were: (1) chronic inflammatory systemic disease; (2) all psychiatric disorders except depression and anxiety (due to high comorbidity); (3) occlusal splint therapy in the past 12 months; (4) ongoing extensive dental treatment; and (5) conditions contradicting MRI examination.

Recruitment of participants started in April 2016 and ended in December 2017. Screening was paused during holiday periods (June-August) and during February-April in 2017 due to technical issues with the MRI machine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Internet-based multimodal pain program (Behavioral)

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}.

干预措施: Occlusal splint (Device)

结局指标

主要结局

Change in The Graded Chronic Pain Scale

时间窗: 3 months and 6 months follow-ups

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

Change in Pain-related disability

时间窗: 3 months and 6 months follow-ups

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.

次要结局

  • Anxiety(3 months and 6 months follow-ups)
  • Depression(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)

研究者

发起方
Malmö University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Per Alstergren

Professor, Senior Consultant, Pro Dean

Malmö University

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