Trial record 5 of 123 for:    "Hereditary neuropathy with liability to pressure palsy"

Nociceptive Processing in Acute Cutaneous Nerve Entrapment Syndrome

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01920880
First received: July 12, 2013
Last updated: August 9, 2013
Last verified: June 2013
  Purpose

Rationale: Chronic abdominal pain is a frequently occurring condition. Although hardly ever considered, the abdominal wall is the primary cause in 10-30% of cases. Most often it is caused by entrapment of an intercostal nerve in the anterior rectus sheath, the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES). Treatment consists of local anaesthetic injections combined with methyl-prednisolon. When ineffective, a neurectomy at the site of penetration out of the ventral rectus sheet should be considered. This neurectomy however is effective in 73% of cases, leaving some 25% of patients in pain. Whether these refractory ACNES patients suffer from underlying pathologic pain disorders is subject to investigation, by using quantitative sensory testing (QST).

Objective: To investigate nociceptive processing and possible underlying pathological pain processing mechanisms in ACNES patients.

Study design: An observational case-control study.

Study population: Patients treated for ACNES (n = 40) compared to healthy controls from an existing database.

Measurements: Quantitative sensory testing (QST) of nociception, performed after treatment of ACNES for both successfully treated and refractory patients in comparison to healthy controls. Visual Analogue Scores (VAS) measured before, during and after testing procedures. Pain Anxiety Symptom Scale (PASS) and Pain Catastrophizing Scale (PCS) questionnaires.

Main study parameters: Pressure pain and electrical pain thresholds as investigated by QST. Secondary study parameters are VAS-scores and results of PASS and PCS questionnaires.


Condition Intervention
Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)
Other: Quantitative Sensory Testing analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Nociceptive Processing in Acute Cutaneous Nerve Entrapment Syndrome: a Quantitative Sensory Testing Analysis.

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • pressure pain threshold [ Time Frame: > 6 weeks after treatment ] [ Designated as safety issue: No ]
    The pressure pain threshold (pPT) will be determined by pressing an electronic pressure algometer, which has a surface area of 1 cm2, on a distinct muscles. The patient will be asked to say 'now' when the sensation is rated as unpleasant. The pressure will be increased at a rate of 50 kPa/sec until the pPT is reached.


Secondary Outcome Measures:
  • Electrical Sensation Threshold (eST) [ Time Frame: > 6 weeks after treatment ] [ Designated as safety issue: No ]

    Electrical QST will be measured using a computerized electric stimulation device delivering constant current skin stimulation via self-adhesive electrodes.

    Electric sensation threshold (eST): when electric sensation is first felt.


  • Electrical Pain Threshold (ePT) [ Time Frame: > 6 weeks after treatment ] [ Designated as safety issue: No ]

    Electrical QST will be measured using a computerized electric stimulation device delivering constant current skin stimulation via self-adhesive electrodes.

    Electric pain threshold (ePT): when electric sensation is rated as unpleasant


  • Electrical Pain Tolerance Threshold (ePTT) [ Time Frame: >6 weeks after treatment ] [ Designated as safety issue: No ]

    Electrical QST will be measured using a computerized electric stimulation device delivering constant current skin stimulation via self-adhesive electrodes.

    Electric pain tolerance threshold (ePTT): when electric sensation is intolerable.


  • Electric Wind-Up Response (e-WUR) [ Time Frame: > 6 weeks after treatment ] [ Designated as safety issue: No ]

    Electrical QST will be measured using a computerized electric stimulation device delivering constant current skin stimulation via self-adhesive electrodes.

    Electric wind-up response (eWUR): rated pain after repeated stimuli


  • Visual Analogue Scale [ Time Frame: > 6 weeks after treatment ] [ Designated as safety issue: No ]
    Patients will be asked to mark on a 100mm VAS line the average pain in a pain diary. The boundaries of these lines are "no pain" on the upper left site and "unbearable pain" on the upper right site.


Other Outcome Measures:
  • Pain and Anxiety Symptom Scale (PASS) [ Time Frame: > 6wks after treatment ] [ Designated as safety issue: No ]
    The pain anxiety symptom scale measures four aspects of pain related anxiety: 1) fear for pain, 2) cognitive anxiety, 3) flight or avoidance behavior, 4) physiological symptoms of pain. Elevated scores on this 40-item questionnaire indicate a high level of pain- related anxiety.

  • Pain Catastrophizing Scale (PCS) [ Time Frame: > 6wks after treatment ] [ Designated as safety issue: No ]
    Pain catastrophizing affects how individuals experience pain. The PCS yields a three component solution comprising ruminating ("I can ́t stop thinking about how much it hurts"), magnifying (e.g. "I'm afraid that something serious might happen"), and helplessness ("There is nothing I can do to reduce the intensity of my pain").

  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: > 6wks after treatment ] [ Designated as safety issue: No ]
    The Hospital Anxiety and Depression Scale is a 14-item questionnaire of which 7 of the items relate to anxiety (HADS-A) and 7 to depression (HADS-D). The scoring system used is a Likert scale (0 to 3 points) and therefore the data returned is ordinal. A patient can score between 0 and 21. The HADS aims to detect emotional disorder in patients under investigation and treatment in medical and surgical departments


Estimated Enrollment: 40
Study Start Date: June 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ACNES patients
Patients being treated in past for anterior cutaneous nerve entrapment syndrome
Other: Quantitative Sensory Testing analysis
Healthy controls
Healthy controls
Other: Quantitative Sensory Testing analysis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study population will consist of ACNES patients that have been treated both successfully and refractory. The control group will consist of demographically equal healthy controls from an existing database

Criteria

Inclusion Criteria:

  1. Patient has been diagnosed with abdominal complaints, matching ACNES:

    • Patient had a constant site of tenderness that is superficially located with a small (<2cm2) area of maximal tenderness.
    • The most intense pain could be localized with the tip of one finger.
    • Tenderness increased by abdominal muscle tensing (Carnett's test).
  2. has been treated (successfully and unsuccessfully) for ACNES.
  3. Patient is at least 18 years old on the day the informed consent form will be signed.
  4. Patient is willing and able to comply with the trial protocol.
  5. Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.

Exclusion Criteria:

  1. Abdominal complaints were due to a condition other than ACNES (e.g. pain related to scar tissue).
  2. Patient has (a history of) another (chronic) pain syndrome that interferes with the interpretation of QST results.
  3. Patient has (a history of) Raynaud syndrome or fenomenon, or a medical disorder that interferes with the study measurements or may pose a risk for the patient.
  4. Patient does not feel a pinprick test to the lower extremities, due to affected sensory input (e.g. neuropathy as a result of diabetes mellitus).
  5. Female patient is pregnant during the course of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01920880

Locations
Netherlands
Radboud University Medical Centre
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: H. van Goor, Prof. MD Radboud University
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01920880     History of Changes
Other Study ID Numbers: NL43583.091.13
Study First Received: July 12, 2013
Last Updated: August 9, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
Anterior cutaneous nerve entrapment syndrome
ACNES
chronic abdominal wall pain
CAWP

Additional relevant MeSH terms:
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Nervous System Malformations
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 28, 2014