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The Significance of Peripheral Input

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ClinicalTrials.gov Identifier: NCT04764045
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Finn Borgbjerg Moltke, Bispebjerg Hospital

Brief Summary:
The investigators want to examine trigger point injections of local anesthetics, in patients with post operative neuropathic pain, determine changes in sensory disturbances such as allodynia, hyperalgesia and thermal sensitivity and examine whether trigger point injections will attenuate pain in rest and activity.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: Ropivacaine Not Applicable

Detailed Description:

The presence of cutaneous trigger points in the surgical incision of patients with post-surgery pain has been shown in our pain clinic, all patients have persistent pain for more than 3 month and different sensory disturbances.

Examinations with trigger point injections of local anesthetics have been used to determine the influence of peripheral changes and the significance of afferent input on persistent post-surgery neuropathic pain.

In the present study the investigators will document the influence of cutaneous trigger point injections for both subjective pain experience and objective findings in the area such as allodynia, hyperalgesia and thermal sensitivity. The investigators expect reduction in spontaneous pain intensity and de-crease in peripheral sensory disturbances and will determine the significance of peripheral input in persistent neuropathic pain.

The investigators aim to investigate whether injection of local anesthesia into trigger points compared with placebo (saline) injection will attenuate pain and normalize abnormal sensations, such as hyperalgesia and allodynia. The investigators believe this to be an important investigation to understand the mechanisms behind chronic post-surgery pain.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Significance of Peripheral Input in Patients With Post Surgery Neuropathic Pain: Evaluation of Trigger Point Anesthesia. A Double-blind, Randomized, Controlled Exploratory Study
Actual Study Start Date : November 20, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ropivacaine injection in trigger points
Ropivacaine injection 1 ml in all trigger points in and around scar after operation in knee, shoulder and foot, one time, duration 3 minutes
Drug: Ropivacaine
Injection of 1 ml Ropivacaine in all trigger points in and around scar. Injection of 1 ml saline in all trigger points in and around scar.
Other Name: Saline

Placebo Comparator: Placebo injection in trigger points
Saline injection 1 ml in all trigger points in and around scar after operation in knee, shoulder and foot, one time, duration 3 minutes
Drug: Ropivacaine
Injection of 1 ml Ropivacaine in all trigger points in and around scar. Injection of 1 ml saline in all trigger points in and around scar.
Other Name: Saline




Primary Outcome Measures :
  1. Change in worst pain in rest and in activity [ Time Frame: 30 minutes ]
    Change in worst pain assessed on a visual analogue scale (VAS, 0-100 mm) at rest and after stair walking/abduction of shoulder, before and after trigger point injections compared to baseline pain score


Secondary Outcome Measures :
  1. Change in area of sensory disturbances [ Time Frame: 30 minutes ]
    Area of pin-prick hyperalgesia, using von Frey filament 60 g and brush allodynia, using Somdic brush, assessed pre- and post-injection. Areas identified at a control day between the two intervention days.

  2. Change in warm and cold detection, threshold and tolerance before and after intervention in area with hyperalgesia compared to normal skin [ Time Frame: 30 minutes ]
    Detection, thresholds and tolerance for cold and heat within the hyperalgesia area compared to normal skin at the contralateral site, before and after trigger point injections. All measures made with Somedic MSA Thermal Stimulator



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years old
  • Patients with chronic pain (daily VAS pain scores >30 mm) for at least 3 months after knee, shoulder or foot surgery
  • Patients with at least one identifiable trigger point in relation to incision from the knee, shoulder or foot surgery. A trigger point is defined as an ar-ea in relation to the incision from surgery, in which a light pressure from a cotton pin radiate pain to the nearby area, and exudes a motor reflex causing withdrawal of the leg
  • A written informed consent to participate in the study after having fully understood the contents of the protocol and restrictions

Exclusion Criteria:

  • Patients who cannot cooperate
  • Patients who cannot understand or speak Danish.
  • Patients with allergy to the drugs used in the study
  • Patients in treatment with vitamin K antagonists.
  • Patients with other pain conditions
  • Patients with diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04764045


Locations
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Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2400 NV
Contact: Marianne R Saugbjerg, RN, MHH    +45 2145 4462    marianne.roerbaek.saugbjerg@regionh.dk   
Contact: Finn B Moltke, MD    +45 2116 0444    finn.borgbjerg.moltke.01@regionh.dk   
Sponsors and Collaborators
Bispebjerg Hospital
Publications:
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Responsible Party: Finn Borgbjerg Moltke, MD, clinical professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT04764045    
Other Study ID Numbers: NP-FM-19
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Finn Borgbjerg Moltke, Bispebjerg Hospital:
Peripheral input
Trigger point injection
Post operative pain
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents