Eye Movement Desensitization and Reprocessing (EMDR) as a Treatment for Chronic Painful Diabetic Peripheral Neuropathy

NCT ID: NCT06171230

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-03-31

Brief Summary

The goal of this clinical trial is to investigate the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy in reducing pain intensity in individuals with chronic painful diabetic neuropathy (PDN). The main questions it aims to answer are:

1. Does EMDR therapy significantly reduce pain intensity in individuals with chronic PDN?

2. What is the impact of EMDR therapy on secondary outcomes, specifically anxiety, sleep disturbances, and personalized pain-related limitations? Additionally, the study will explore the correlation between pain scores and symptoms of post-traumatic stress disorder (PTSD) in individuals with chronic PDN.

Participants will undergo EMDR therapy sessions, focusing on the processing of emotionally charged pain-related events and addressing the pain itself. Main tasks for participants include active engagement in EMDR therapy sessions. Treatment outcomes, including changes in pain intensity, anxiety levels, sleep quality, and personalized pain-related limitations, will be monitored throughout the study.

Detailed Description

The study adopts a single-case experimental design, replicated nine times (N-of-1 study).

Research on the effectiveness of EMDR therapy for neuropathic pain is limited to studies on phantom pain (and complex regional pain syndrome (CRPS). In the case of CRPS, two case reports are available, and for phantom pain, there is one RCT with 60 participants and three studies with 10 or fewer participants, without a control group. In the phantom pain studies, EMDR therapy focused on processing memories of events leading to the onset and exacerbation of pain (initial injury, amputation) and pain-related memories with current emotional charge. Sometimes, but not always, these events were life-threatening, as seen in PTSD (American Psychiatric Association Painful experiences, such as falling on the stump, or anticipated catastrophes (nightmares or disaster fantasies) with current emotional charge, were also processed. In the CRPS studies, EMDR therapy targeted traumatic events, including those from childhood, and pain-related events. In all studies, after the events were processed, pain itself was taken as the target for EMDR therapy. The studies demonstrate that after EMDR therapy, pain intensity decreases, as do comorbid symptoms.

Research on the effectiveness of EMDR therapy as a treatment for chronic PDN, to the best of our knowledge, has not been conducted. The aim of the presented study is to investigate the effect of EMDR therapy on chronic PDN.

Conditions

Neuropathic Pain; Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eye Movement Desensitization and Reprocessing

Participants will undergo six 90-minute EMDR sessions. The EMDR treatment concludes when the selected target images attain a Subjective Units of Disturbance (SUD) score of 0 or when three consecutive sessions show no further decrease in the SUD. Between the baseline phase (phase A) and the intervention phase (phase C), an attention control phase is introduced (phase B). This phase controls for the non-specific effects of the intervention, such as attention, treatment contact, and social support.

Group Type: EXPERIMENTAL

Eye Movement Desensitization and Reprocessing

Intervention Type: OTHER

Using the LEC and PCL-5, emotionally charged images are selected at the onset of the EMDR intervention. Initially, events meeting the criteria for PTSD (A-criterion worthy events) are processed. Subsequently, pain-related experiences, including any distressing images, are addressed. If the emotional charge of the events diminishes (SUD=0) before the completion of the six EMDR sessions, the participant is categorized as an 'early completer,' and the post-assessment is conducted immediately. The duration of each EMDR session is 90 minutes.

Attention control phase

Intervention Type: OTHER

Prior to EMDR, there is a two-week attention control phase. During this phase, the participant is asked to daily record their activities, emotions, and thoughts when experiencing pain. This information is further explored and evaluated in two sessions lasting 45 minutes each, involving in-depth discussions with the participant.

Interventions

Eye Movement Desensitization and Reprocessing

Using the LEC and PCL-5, emotionally charged images are selected at the onset of the EMDR intervention. Initially, events meeting the criteria for PTSD (A-criterion worthy events) are processed. Subsequently, pain-related experiences, including any distressing images, are addressed. If the emotional charge of the events diminishes (SUD=0) before the completion of the six EMDR sessions, the participant is categorized as an 'early completer,' and the post-assessment is conducted immediately. The duration of each EMDR session is 90 minutes.

Intervention Type: OTHER

Attention control phase

Prior to EMDR, there is a two-week attention control phase. During this phase, the participant is asked to daily record their activities, emotions, and thoughts when experiencing pain. This information is further explored and evaluated in two sessions lasting 45 minutes each, involving in-depth discussions with the participant.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age: ≥ 18 years.
• Diagnosis of Diabetes Mellitus.
• Severity of pain in the past month, NRS-pain score ≥ 6.
• Ability to communicate in both written and spoken Dutch.
• Willingness to participate in the study (signed informed consent (IC)).

Exclusion Criteria

• Severe psychiatric disorders requiring immediate treatment.
• IQ < 80.
• Initiation of medication within 3 months before the start of the study (medication in use for more than 3 months can be maintained; discontinuation of medication during the study is possible but not desirable).
• Concurrent psychotherapeutic treatment targeting neuropathic pain during the study.
• Substance abuse and/or dependence, unless medically prescribed.
• Inability to complete the questionnaires.
• Co-morbid conditions affecting the lower extremities, such as peripheral arterial disease, severe rheumatoid arthritis, osteoarthritis. Other conditions causing pain in the feet and/or damage to the peripheral nervous system, for example, ulcers.
• Co-morbid chronic pain syndromes.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dijklander Ziekenhuis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suzan Zyto, Drs

Role: PRINCIPAL_INVESTIGATOR

Dijklander Ziekenhuis

Locations

Dijklander Ziekenhuis

Hoorn, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Patrick vd Molen, Drs

Role: CONTACT

p.r.vandermolen@dijklander.nl

0031643120551

Suzan Zyto, Drs

Role: CONTACT

s.zyto@dijklander.nl

Facility Contacts

Aine Honohan

Role: primary

a.g.honohan@dijklander.nl

+31626494889

Other Identifiers

DOC 090

Identifier Type: -

Identifier Source: org_study_id