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The Significance of Peripheral Input

Primary Purpose

Neuropathic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neuropathic Pain focused on measuring Peripheral input, Trigger point injection, Post operative pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bispebjerg HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ropivacaine injection in trigger points

Placebo injection in trigger points

Arm Description

Ropivacaine injection 1 ml in all trigger points in and around scar after operation in knee, shoulder and foot, one time, duration 3 minutes

Saline injection 1 ml in all trigger points in and around scar after operation in knee, shoulder and foot, one time, duration 3 minutes

Outcomes

Primary Outcome Measures

Change in worst pain in rest and in activity
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

Change in area of sensory disturbances
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.
Change in warm and cold detection, threshold and tolerance before and after intervention in area with hyperalgesia compared to normal skin
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

Full Information

First Posted
March 9, 2020
Last Updated
February 17, 2021
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04764045
Brief Title
The Significance of Peripheral Input
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Peripheral input, Trigger point injection, Post operative pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine injection in trigger points
Arm Type
Active Comparator
Arm Description
Ropivacaine injection 1 ml in all trigger points in and around scar after operation in knee, shoulder and foot, one time, duration 3 minutes
Arm Title
Placebo injection in trigger points
Arm Type
Placebo Comparator
Arm Description
Saline injection 1 ml in all trigger points in and around scar after operation in knee, shoulder and foot, one time, duration 3 minutes
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in worst pain in rest and in activity
Description
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
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Change in area of sensory disturbances
Description
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.
Time Frame
30 minutes
Title
Change in warm and cold detection, threshold and tolerance before and after intervention in area with hyperalgesia compared to normal skin
Description
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
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400 NV
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne R Saugbjerg, RN, MHH
Phone
+45 2145 4462
Email
marianne.roerbaek.saugbjerg@regionh.dk
First Name & Middle Initial & Last Name & Degree
Finn B Moltke, MD
Phone
+45 2116 0444
Email
finn.borgbjerg.moltke.01@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27199314
Citation
Wijayasinghe N, Ringsted TK, Bischoff JM, Kehlet H, Werner MU. The role of peripheral afferents in persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled, crossover trial of ultrasound-guided tender point blockade. Br J Anaesth. 2016 Jun;116(6):829-37. doi: 10.1093/bja/aew071.
Results Reference
background
PubMed Identifier
24704366
Citation
Haroutounian S, Nikolajsen L, Bendtsen TF, Finnerup NB, Kristensen AD, Hasselstrom JB, Jensen TS. Primary afferent input critical for maintaining spontaneous pain in peripheral neuropathy. Pain. 2014 Jul;155(7):1272-1279. doi: 10.1016/j.pain.2014.03.022. Epub 2014 Apr 2.
Results Reference
background
PubMed Identifier
29570507
Citation
Haroutounian S, Ford AL, Frey K, Nikolajsen L, Finnerup NB, Neiner A, Kharasch ED, Karlsson P, Bottros MM. How central is central poststroke pain? The role of afferent input in poststroke neuropathic pain: a prospective, open-label pilot study. Pain. 2018 Jul;159(7):1317-1324. doi: 10.1097/j.pain.0000000000001213.
Results Reference
background

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The Significance of Peripheral Input

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