Eye Movement Desensitization and Reprocessing (EMDR) as a Treatment for Chronic Painful Diabetic Peripheral Neuropathy (EMDR4CPDN)

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Neuropathic Pain
• Intervention / Treatment: Other: Eye Movement Desensitization and Reprocessing; Other: Attention control phase

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick vd Molen, Drs; Phone Number: 0031643120551; Email: p.r.vandermolen@dijklander.nl
• Study Contact Backup: Name: Suzan Zyto, Drs; Email: s.zyto@dijklander.nl

Study Locations

• Netherlands
  • Hoorn, Netherlands, 1624 NP
    • Recruiting
    • Dijklander Ziekenhuis
    • Contact: Aine Honohan; Phone Number: +31626494889; Email: a.g.honohan@dijklander.nl
    • Sub-Investigator: Patrick van der Molen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity measured with the Numeric Rating Scale (NRS)	The NRS is an 11-point numeric scale form 0 (no pain ) to 10 (worst pain)	Pain intensity is assessed once daily in the evening for a maximum of 154 days (throughout all phases of the study (phase A, phase B, phase C, post-assessment phase, and follow-up phase.)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Anxiety is scored on an 11-point scale from 0 (no anxiety) to 10 (most imaginable anxiety).	The anxiety level is assessed once daily in the evening for maximum of 154 days (throughout all phases of the study (phase A, phase B, phase C, post-assessment phase, and follow-up phase.)
Quality of your sleep	Sleep problems are scored on an 11-point scale from 0 (least possible sleep) to 10 (best possible sleep).	Sleep problems are assessed once daily in the evening for a maximum of 154 days (throughout all phases of the study (phase A, phase B, phase C, post-assessment phase, and follow-up phase.)
Pain Disability Index (PDI) Limitations in daily activities	Two questions from the PDI, deemed most relevant by the participant, are chosen in collaboration with the participant. The limitations are scored on an 11-point scale from 0 (no limitations) to 10 (fully restricted).	The selected questions from the PDI are assessed once daily in the evening for a maximum of 154 days (throughout all phases of the study (phase A, phase B, phase C, post-assessment phase, and follow-up phase.)

Collaborators and Investigators

• Sponsor: Dijklander Ziekenhuis
• Investigators: Principal Investigator: Suzan Zyto, Drs, Dijklander Ziekenhuis

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Neuralgia; Peripheral Nervous System Diseases
• Other Study ID Numbers: DOC 090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No