Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05798949
Status:
RECRUITING
Last Update Posted:
2023-04-05
First Post:
2023-03-09
Brief Title:
Chronic Pain Rehabilitation in Patients With Small Fiber Neuropathy
Sponsor:
Academisch Ziekenhuis Maastricht
Organization:
Academisch Ziekenhuis Maastricht
Study Overview
Official Title:
Chronic Pain Rehabilitation in Patients With Small Fiber Neuropathy
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None