Chronic Pain Rehabilitation in Patients With Small Fiber Neuropathy

NCT05798949 | Unknown

• 1 other identifier: SFN-rehabilitation
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Small fiber neuropathy (SFN) is a condition that is dominated by invalidating neuropathic pain. Pharmacological neuropathic pain treatment is often disappointing, since pain reduction is mostly slight and side effects can be debilitating. Although neuropathic pain is caused by a lesion of the somatosensory system, also psychological factors, such as fear and catastrophizing, appear to play a role in the origin and maintenance of disability in chronic pain. Rehabilitation based on pain education and cognitive behavioral treatment including elements of acceptance and commitment therapy, exposure in vivo or graded activity can be performed to influence these factors. To date no specific rehabilitation programs are available for patients diagnosed with SFN.

Conditions

Small Fiber Neuropathy

Outcome Measures

Primary Outcomes (2)

• Disability measured with small fiber neuropathy rash built overall disability scale (SFN-RODS)

  This is a questionnaire consisting of 12 questions, in which a higher score is indicating more disability. There is no cut-off point. The minimum score is 0. The maximum score is 100.

  Through study completion, an average of 1 year

• Health related quality of life measured with short form 12 questionnaire (SF-12)

  This is a questionnaire consisting of 8 items measuring the quality of life, in which a lower score is indicating a lower quality of life compared to healthy individuals. The minimum score is 0, and the maximum score is 100.

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Pain intensity measured with numeric rating scale (NRS)

  Through study completion, an average of 1 year

• Mood measured with hospital anxiety and depression scale (HADS)

  Through study completion, an average of 1 year

• Pain catastrophizing measured with pain catastrophizing scale (PCS)

  Through study completion, an average of 1 year

Study Arms (3)

Exposure in vivo-therapy

ACTIVE COMPARATOR

In the first phase, patients with idiopathic small fiber neuropathy will receive exposure in vivo therapy for at least 4 weeks, 2 sessions/week. In the second phase, the therapy will be expanded with either 4 weeks or 6 weeks, 2sessions/week, depending on the outcome of the first session.

Behavioral: Chronic pain rehabilitation: exposure in vivo

Graded activity-therapy

ACTIVE COMPARATOR

In the first phase, patients with idiopathic small fiber neuropathy will receive graded activity-therapy for at least 4 weeks, 2 sessions/week. In the second phase, the therapy will be expanded with either 4 weeks or 6 weeks, 2sessions/week, depending on the outcome of the first session.

Behavioral: Chronic pain rehabilitation: graded activity

Acceptance and commitment therapy

ACTIVE COMPARATOR

In the first phase, patients with idiopathic small fiber neuropathy will receive acceptance and commitment therapy for at least 4 weeks, 2 sessions/week. In the second phase, the therapy will be expanded with either 4 weeks or 6 weeks, 2sessions/week, depending on the outcome of the first session.

Behavioral: Chronic pain rehabilitation: acceptance and commitment therapy

Interventions

Chronic pain rehabilitation: exposure in vivo BEHAVIORAL

Behavioral, chronic pain rehabilitation therapy

Also known as: Exposure in vivo

Exposure in vivo-therapy

Chronic pain rehabilitation: graded activity BEHAVIORAL

Behavioral, chronic pain rehabilitation therapy

Also known as: graded activity

Graded activity-therapy

Chronic pain rehabilitation: acceptance and commitment therapy BEHAVIORAL

Behavioral, chronic pain rehabilitation therapy

Also known as: acceptance and commitment therapy

Acceptance and commitment therapy

Eligibility Criteria

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

You may qualify if:

• Aged older than 18 years,
• Skin-biopsy proven idiopathic small fiber neuropathy (SFN),
• Main goal/purpose to achieve with rehabilitation therapy.

You may not qualify if:

• Are not able to provide written informed consent,
• Have an underlying condition of SFN (diabetes, SCN (sodium voltage-gated channel alpha) 9A (subunit 9A) /10A (subunit 10A) /11A (subunit 11A) mutation, hypothyroidism, renal failure, vitamin B12 deficiency, monoclonal gammopathy of undetermined significance, alcohol abuses, malignancies, chemotherapeutic drugs),
• Have other neurological disease than SFN that may cause pain in the feet and/or damage to the somatosensory nervous system, are excluded,
• Have received any form of cognitive behavioral therapy within the last 6 months will be excluded from this study,
• Have insufficient comprehension of the Dutch language.

Sponsors & Collaborators

• Academisch Ziekenhuis Maastricht: lead

Study Sites (2)

Adelante Zorggroep

Maastricht, Limburg, 6229HX, Netherlands

RECRUITING

Maastricht University Medical Center

Maastricht, Netherlands

RECRUITING

Related Publications (1)

• Damci A, den Hollander M, Hoeijmakers JGJ, Faber CG, Goossens MEJB, Verbunt JAMCF. Biopsychosocial rehabilitation therapy in small fiber neuropathy: research protocol to study the effect of rehabilitation treatment. Front Neurol. 2024 Nov 13;15:1493326. doi: 10.3389/fneur.2024.1493326. eCollection 2024.

  PMID: 39606707 DERIVED

MeSH Terms

Conditions

Small Fiber Neuropathy

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• J. AC Verbunt, MD, PhD

  Adelante Zorggroep

  PRINCIPAL INVESTIGATOR

• J. GJ Hoeijmakers, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A. Damci, MD

CONTACT

0031433876584; aysun.damci@mumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Sequential replicated randomized single-case experimental-design

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 5, 2023
• Study Start: March 9, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)