The Significance of Peripheral Input

NCT ID: NCT04764045

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-20

Study Completion Date

2021-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuropathic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

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.

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

Group Type PLACEBO_COMPARATOR

Ropivacaine

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Saline

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Finn Borgbjerg Moltke

MD, clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bispebjerg Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marianne R Saugbjerg, RN, MHH

Role: primary

+45 2145 4462

Finn B Moltke, MD

Role: backup

+45 2116 0444

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27199314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24704366 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29570507 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NP-FM-19

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ACD440 Gel in Peripheral Neuropathic Pain
NCT05416931 COMPLETED PHASE2