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Chronic Pain Rehabilitation in Patients With Small Fiber Neuropathy

Primary Purpose

Small Fiber Neuropathy

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Chronic pain rehabilitation: exposure in vivo
Chronic pain rehabilitation: graded activity
Chronic pain rehabilitation: acceptance and commitment therapy
Sponsored by
Academisch Ziekenhuis Maastricht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Fiber Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Adelante ZorggroepRecruiting
  • Maastricht University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Exposure in vivo-therapy

Graded activity-therapy

Acceptance and commitment therapy

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Pain intensity measured with numeric rating scale (NRS)
This is a measurement about the pain intensity. On a scale of 0-10 (Likert 11), a higher score is indicating more pain, in which 0 is indicating no pain at all (minimum score), and 10 is indicating the worst pain ever. (maximum score).
Mood measured with hospital anxiety and depression scale (HADS)
HADS is a questionnaire measuring symptoms of anxiety and depression with 14 questions, consisting of 2 subscales (with each 7 items): a score between 0-7 is seen as normal, between 8-10 is seen as borderline, and a score higher than 11 indicates an underlying anxiety or depressive disorder. The minimum score is 0, and the maximum score is 21.
Pain catastrophizing measured with pain catastrophizing scale (PCS)
PCS is a questionnaire consisting of 13 questions, a higher score is indicating the presence of more catastrophic thoughts, there is no cut-off point. The minimum score is 0, and the maximum score is 52.

Full Information

First Posted
March 9, 2023
Last Updated
March 22, 2023
Sponsor
Academisch Ziekenhuis Maastricht
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1. Study Identification

Unique Protocol Identification Number
NCT05798949
Brief Title
Chronic Pain Rehabilitation in Patients With Small Fiber Neuropathy
Official Title
Chronic Pain Rehabilitation in Patients With Small Fiber Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Ziekenhuis Maastricht

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Small fiber neuropathy (SFN) presents with neuropathic pain and autonomic dysfunction, caused by damage of the myelinated Aδ- and unmyelinated C-fibers. Neuropathic pain in SFN is chronic and severe. In 47% of the SFN cases, an underlying cause can be found. The diagnosis of SFN is established on the clinical signs and symptoms, in combination with reduced intra-epidermal nerve fiber density in the skin biopsy and/or abnormal quantitative sensory testing, with no abnormalities in the nerve conduction test (no large fiber involvement). Without underlying cause or when causative treatment is not sufficient, the treatment is focused on symptomatic neuropathic pain relief. Nevertheless, current pharmacological treatment is not sufficient enough in pain relief. In less than 50% of the pain patients, pain reduction of 30-40% has been observed with the most potent analgesia. Besides the lack of effectiveness of pharmacological medication, side effects and abuse are reported. These insufficient treatment options of SFN enables the necessity to search for other possible treatments. In the treatment of (chronic) pain disability, a biopsychosocial approach seems to be effective in reducing disability and quality of life (QOL) in SFN. As we know based on earlier studies, chronic (neuropathic) pain, such as SFN, is influenced by several psychological factors, especially in causing and perpetuating pain. First, catastrophizing is one of those disabling psychological factors, which is defined as exaggerated negative mental set brought to bear during actual or anticipated pain experience Catastrophizing is seen as a precursor of pain, rather than consequence. Evidence showed a relation between the severity of chronic neuropathic pain and catastrophizing. Pain catastrophizing has been correlated to pain intensity, independent of physical impairment. In chronic pain, negative and catastrophic thoughts about illness often increase the level of disability. It seems that catastrophizing is one of the factors influencing QOL. Second, fear is another disabling psychological factor. Fear of pain can result in avoidance behavior and reduction of daily activities. Avoidance is the behavior aimed at postponing or preventing an aversive situation from occurring, which are mostly seen as a threat. According to the basic fear avoidance (conditioning) model, chronic pain and disability are induced by behavior. Neutral stimulus receives a negative load. In daily activities, these stimuli will remind patients to the painful experiences and so predicting pain. The intensity of pain combined with psychosocial factors can result in escape and avoidance behavior with eventually an impact for the level of physical activity. These factors can be treated with cognitive behavioral therapy (CBT), which aims to change the behavior, mindset, or feelings of the patient, helping to experience less distress, enjoying more and being more productive. Varying CBT modalities exists: exposure in vivo, acceptance and commitment therapy (ACT), and graded activity (GA), which will be discussed. All the mentioned modalities will be provided by a treatment team consisting of a psychologist and an occupational therapist, whom both are experienced in the modalities of CBT. For every patient an individualized program will be designed based on the results of a screening. First, a patient will receive education about disabling factors that interfere with functioning in their personal situation. Thereafter, an individual treatment plan containing elements that specifically target disabling factors in the patient's situation will guide further treatment. Additional treatment elements can be based on three cognitive behavioral approaches: exposure in vivo, graded activity and acceptance commitment therapy (ACT). One or more modalities can be combined. The main (primary) objective is to test the effectiveness of a personally tailored rehabilitation treatment targeting the specific psychological and behavioral factors related to decreasing disability, and improving QOL in SFN. The secondary objective is the personally tailored rehabilitation treatment program will have decrease of pain intensity, mood, and pain catastrophizing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Fiber Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Sequential replicated randomized single-case experimental-design
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposure in vivo-therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Graded activity-therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Acceptance and commitment therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Chronic pain rehabilitation: exposure in vivo
Other Intervention Name(s)
Exposure in vivo
Intervention Description
Behavioral, chronic pain rehabilitation therapy
Intervention Type
Behavioral
Intervention Name(s)
Chronic pain rehabilitation: graded activity
Other Intervention Name(s)
graded activity
Intervention Description
Behavioral, chronic pain rehabilitation therapy
Intervention Type
Behavioral
Intervention Name(s)
Chronic pain rehabilitation: acceptance and commitment therapy
Other Intervention Name(s)
acceptance and commitment therapy
Intervention Description
Behavioral, chronic pain rehabilitation therapy
Primary Outcome Measure Information:
Title
Disability measured with small fiber neuropathy rash built overall disability scale (SFN-RODS)
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Health related quality of life measured with short form 12 questionnaire (SF-12)
Description
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.
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Pain intensity measured with numeric rating scale (NRS)
Description
This is a measurement about the pain intensity. On a scale of 0-10 (Likert 11), a higher score is indicating more pain, in which 0 is indicating no pain at all (minimum score), and 10 is indicating the worst pain ever. (maximum score).
Time Frame
Through study completion, an average of 1 year
Title
Mood measured with hospital anxiety and depression scale (HADS)
Description
HADS is a questionnaire measuring symptoms of anxiety and depression with 14 questions, consisting of 2 subscales (with each 7 items): a score between 0-7 is seen as normal, between 8-10 is seen as borderline, and a score higher than 11 indicates an underlying anxiety or depressive disorder. The minimum score is 0, and the maximum score is 21.
Time Frame
Through study completion, an average of 1 year
Title
Pain catastrophizing measured with pain catastrophizing scale (PCS)
Description
PCS is a questionnaire consisting of 13 questions, a higher score is indicating the presence of more catastrophic thoughts, there is no cut-off point. The minimum score is 0, and the maximum score is 52.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged older than 18 years, Skin-biopsy proven idiopathic small fiber neuropathy (SFN), Main goal/purpose to achieve with rehabilitation therapy. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
A. Damci, MD
Phone
0031433876584
Email
aysun.damci@mumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. AC Verbunt, MD, PhD
Organizational Affiliation
Adelante Zorggroep
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. GJ Hoeijmakers, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adelante Zorggroep
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. A.C. Verbunt, MD, PhD
Phone
00313877151
Email
j.verbunt@adelante-zorggroep.nl
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catharina G Faber, MD, PhD
Phone
+31433877059
Email
c.faber@mumc.nl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Chronic Pain Rehabilitation in Patients With Small Fiber Neuropathy

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