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

Diabetes Mellitus Clinical Trial

— EMDR4CPDN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06171230
• Other study ID #: DOC 090
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Dijklander Ziekenhuis
• Contact: Patrick vd Molen, Drs
• Phone: 0031643120551
• Email: p.r.vandermolen[@]dijklander.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Neuralgia
• Neuropathic Pain
• Peripheral Nervous System Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Dijklander Ziekenhuis	Hoorn

Sponsors (1)

Lead Sponsor	Collaborator
Dijklander Ziekenhuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.)
Secondary	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.)
Secondary	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.)