Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00010607

Trial Description

start of 1:1-Block title

Title

Effect of spinal cord and peripheral nerve stimulation on sensory profile and on endogenous pain modulation

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Peripheral Nerve and Spinal Cord Stimulation (PNS and SCS) represent effective pain treatment. Further acceptance of this invasive method is hampered by the nebulosity regarding the mechanism of action. Different measurement methodes should figure out the mechanisms of SCS and PNS.
Patients with pain relief under SCS or PNS get measured at first with inactivated stimulation and then with activated stimulation.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Peripheral Nerve and Spinal Cord Stimulation (PNS and SCS) represent effective pain treatment in particular neuropathic pain states and in complex regional pain syndrome.
The DFNS (German Network on Neuropathic Pain) has developed a protocol for Quantitative Sensory Testing (QST) which is established internationally as the golden standard for QST. Using this protocol, small changes in the somatosensory function and pain thresholds can be captured.
Another previously established technique, called conditioned pain modulation (CPM), measures the ability of endogenous descending pain inhibition. The ability of pain inhibition can be evaluated by reduction of one painful stimulus through another painful stimulus.
Temperature measurement at the extremity will detect participation of the sympathetic nervous system through stimulation.
These techniques will be used in this study both with activated neurostimulation and without neurostimulation.
The present study aimed to analyzes if PNS and SCS have anti-hyperalgetic effect, improve the endogenous pain modulation or reduce sympathetic activity in the stimulated areas. Correlation between this changes and the analgesic effect was assumed.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00010607
  •   2016/09/28
  •   [---]*
  •   yes
  •   Approved
  •   4968-14, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   complex regional pain syndrome, peripheral nerve injury, raduculopathy, polyneuropathy
  •   M89.0 -  Algoneurodystrophy
  •   G56.4 -  Causalgia
  •   M54.1 -  Radiculopathy
  •   G62.9 -  Polyneuropathy, unspecified
  •   G56 -  Mononeuropathies of upper limb
  •   G57 -  Mononeuropathies of lower limb
  •   G58 -  Other mononeuropathies
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Quantitative Sensory Testing (QST, DFNS protocol), conditioned pain modulation (CPM) and skin temperature measurement in the affected area and contralateral were examined. First measurement after PNS or SCS deactivation. Second measurement during stimulation with consecutive pain reduction in pretest-posttest design.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Quantitative Sensory Testing (QST, DFNS protocol), conditioned pain modulation (CPM) and skin temperature measurement in the affected area and contralateral were examined at first with inactivated stimulation and then with activated stimulation. QST investigates the function of thick-, thinly- and unmyelinated nerve fibers (A-ß, A-δ and C nerve fibers). CPM evaluates the efficacy of diffuse noxious inhibitory controls (DNIC). Temperature measurement is an established indirect technique to detect sympathetic blockade, shown through an increase of skin temperature.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Correlation between this changes and the analgesic effect was assumed.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/09/22
  •   28
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Inclusuion criteria was a reported beneficial effect to neurostimulation and the ability to understand the study design.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Exclusion criteria were no pain relief after SCS or PNS implantation, pain duo to angina pectoris and stump pain after amputation, mental limitations and spasm following neurostimulation.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Abteilung für Schmerzmedizin,Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
    • Mr.  Prof. Dr.  Christoph  Maier 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Abteilung für Schmerzmedizin,Berufsgenossenschaftliches UniversitätsklinikumBergmannsheil
    • Mr.  Prof. Dr.  Christoph  Maier 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Abteilung für Schmerzmedizin,Berufsgenossenschaftliches UniversitätsklinikumBergmannsheil
    • Mr.  Prof. Dr.  Christoph  Maier 
    • Bürkle-de-la-Camp-Platz 1
    • 44789  Bochum
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Abteilung für Schmerzmedizin,Berufsgenossenschaftliches UniversitätsklinikumBergmannsheil
    • Mr.  Prof. Dr.  Christoph  Maier 
    • 4
    • 44789  Bochum
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2016/09/02
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Meyer-Frießem, Christine H.; Wiegand, Theresa; Eitner, Lynn; Maier, Christoph; Mainka, Tina; Vollert, Jan; Enax-Krumova, Elena K. (2019): Effects of Spinal Cord and Peripheral Nerve Stimulation Reflected in Sensory Profiles and Endogenous Pain Modulation. In: The Clinical journal of pain. 35(2): S. 111–120. DOI: 10.1097/AJP.0000000000000661.
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.