Small Fiber NeuropathyNCT05798949
Chronic Pain Rehabilitation in Patients With Small Fiber Neuropathy
A study testing Chronic pain rehabilitation: exposure in vivo, Chronic pain rehabilitation: graded activity and Chronic pain rehabilitation: acceptance and commitment therapy in people with Small Fiber Neuropathy, run by Academisch Ziekenhuis Maastricht at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Fiber Neuropathy
- What is being tested?
- Chronic pain rehabilitation: exposure in vivo, Chronic pain rehabilitation: graded activity and Chronic pain rehabilitation: acceptance and commitment therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesNetherlands
- Study dates
- 9 Mar 2023to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged older than 18 years,
- Skin-biopsy proven idiopathic small fiber neuropathy (SFN),
- Main goal/purpose to achieve with rehabilitation therapy.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Adelante Zorggroep
Maastricht, Limburg, 6229HX
J. A.C. Verbunt, MD, PhD, 00313877151, j.verbunt@adelante-zorggroep.nl
- Recruiting
Maastricht University Medical Center
Maastricht
Catharina G Faber, MD, PhD, +31433877059, c.faber@mumc.nl
About this study
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.
Read the 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.
- Conditions
- Small Fiber Neuropathy
- Being tested
- Chronic pain rehabilitation: exposure in vivo, Chronic pain rehabilitation: graded activity, Chronic pain rehabilitation: acceptance and commitment therapy
- Medical subject headings
- Small Fiber Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic pain rehabilitation: exposure in vivoBehavioural
Also called Exposure in vivo
Behavioral, chronic pain rehabilitation therapy
Chronic pain rehabilitation: graded activityBehavioural
Also called graded activity
Behavioral, chronic pain rehabilitation therapy
Chronic pain rehabilitation: acceptance and commitment therapyBehavioural
Also called acceptance and commitment therapy
Behavioral, chronic pain rehabilitation therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Chronic pain rehabilitation: acceptance and commitment therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
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).
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start9 Mar 2023
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Fiber NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential replicated randomized single-case experimental-design
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Ziekenhuis Maastricht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catharina G. Faber, Academisch Ziekenhuis Maastricht
- Investigators
- J. AC Verbunt, MD, PhD, Principal investigator, Adelante ZorggroepJ. GJ Hoeijmakers, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798949
- Sponsor's protocol ID
- SFN-rehabilitation
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39606707
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain Rehabilitation in Patients With Small Fiber Neuropathy
- ClinicalTrials.gov ID
- NCT05798949
- Acronym / sponsor ID
- SFN-rehabilitation
- Conditions
- Small Fiber Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Academisch Ziekenhuis MaastrichtUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Sequential replicated randomized single-case experimental-design
| Arm | Type | Receives |
|---|---|---|
| Exposure in vivo-therapy | Active comparator | Behavioral: Chronic pain rehabilitation: exposure in vivoIn 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. |
| Graded activity-therapy | Active comparator | Behavioral: Chronic pain rehabilitation: graded activityIn 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. |
| Acceptance and commitment therapy | Active comparator | Behavioral: Chronic pain rehabilitation: acceptance and commitment therapyIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged older than 18 years,
- Skin-biopsy proven idiopathic small fiber neuropathy (SFN),
- Main goal/purpose to achieve with rehabilitation therapy.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic pain rehabilitation: exposure in vivoAlso: Exposure in vivoBehavioral, chronic pain rehabilitation therapy | Behavioural | Exposure in vivo-therapy |
| Chronic pain rehabilitation: graded activityAlso: graded activityBehavioral, chronic pain rehabilitation therapy | Behavioural | Graded activity-therapy |
| Chronic pain rehabilitation: acceptance and commitment therapyAlso: acceptance and commitment therapyBehavioral, chronic pain rehabilitation therapy | Behavioural | Acceptance and commitment therapy |
Primary outcome
Disability measured with small fiber neuropathy rash built overall disability scale (SFN-RODS)
Time frame: Through study completion, an average of 1 year
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)
Time frame: Through study completion, an average of 1 year
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.
3 secondary outcomes
Pain intensity measured with numeric rating scale (NRS)
Time frame: Through study completion, an average of 1 year
Mood measured with hospital anxiety and depression scale (HADS)
Time frame: Through study completion, an average of 1 year
Pain catastrophizing measured with pain catastrophizing scale (PCS)
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Derived from this study: PubMed 39606707Damci 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. AC Verbunt, MD, PhD principal investigator
Adelante Zorggroep
J. GJ Hoeijmakers, MD, PhD principal investigator
Maastricht University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic pain rehabilitation: exposure in vivo, Chronic pain rehabilitation: graded activity and Chronic pain rehabilitation: acceptance and commitment therapy in people with Small Fiber Neuropathy, run by Academisch Ziekenhuis Maastricht at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact A. Damci, MD (0031433876584, aysun.damci@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability measured with small fiber neuropathy rash built overall disability scale (SFN-RODS) (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05798949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.