Treatment with small Qutenza patches over painful trigger points in scars after operation: A blinded study using placebo paths versus active Qutenza patch

The effect of Qutenza application in patients with post-operative neuropathic pain: A double-blind, randomized, controlled pilot study - Qutenza-FM-20

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001022-57-DK

Enrollment

Registered

2020-08-17

Start date

2020-12-18

Completion date

Unknown

Last updated

2022-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative neuropathic pain MedDRA version: 21.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000004852 MedDRA version: 20.0 Level: LLT Classification code 10077974 Term: Peripheral neuropathic pain System Organ Class: 100000004852

Interventions

Trade Name: Qutenza 179 mg kutanplaster Product Name: Qutenza 179 mg cutaneous patch Product Code: EMEA/H/C/00909 Pharmaceutical Form: Cutaneous patch INN or Proposed INN: Capsaicin CAS Number: 404-86

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age > 18 years old • Patients with chronic pain for =3 months, with a daily VAS pain scores =40 mm (VAS 0-100mm, 0=no pain and 100=worst possible pain) after sur-gery • Patients have a score =7 in the neuropathic pain questionnaire DN4 • Negative pregnancy test in fertile women. • Patients with at least one identifiable trigger point in relation to incision in a mobile body part or a positive outcome from our first study (7). A trigger point is defined as an area 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 body part related to the incision. Trigger points will be identified using ultrasound scanning. • Skin must be intact and dry without wounds or stripes in an area of 6 cm in diameter from the trigger point • A written and signed informed consent to participate in the study after having fully understood the contents of the protocol and restrictions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: • Patients who cannot cooperate • Patients who can cooperate but do not understand or speak Danish • Patients with allergy to the drugs used in the study, ingredients or compo-nents in the matrix and cleansing creme* • Women who are not using acceptable effective contraception • Patients suffering from other neuropathic pain conditions.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the present study is to compare the effect of local application of Qutenza® patches covering trigger points in patients with chronic pain after surgery compared to placebo patches. The effects are monitored on pain at rest and during movement, areas of pin-prick hyperalgesia and brush allodynia, detection and pain thresholds for cold and heat within these areas. Our hypothesis is that small local Qutenza® patches applied over trigger points may reduce pain at rest, during movement and decrease sensory disturbances compared with a placebo patch. The present study is a pilot study performed in order to obtain proof of con-cept for a future comparative study between small localized and large Qutenza patches. ;Secondary Objective: Not applicable;Primary end point(s): • Difference in mean changes from baseline in pain score between active and placebo treatment at times day 14, 28 and 90 on a visual analogue scale (VAS 0-100 mm 0 is no pain and 100 is worst possible pain). • Difference in changes from baseline of area of pin-prick hyperalgesia, cold allodynia and brush allodynia assessed using von Frey filament 60 gram, Lindblom roller and Somedic Brush, between active and placebo treatment on day 14, day 28 and day 90. • Difference from baseline in detection, thresholds and tolerance for cold and warmth with-in the hyperalgesia area compared to normal skin, between active and placebo treatment on day 14, day 28 and day 90. If pain relief persists assessments are performed every 14 days.;Timepoint(s) of evaluation of this end point: Day 14, 28 and day 90	—

Measure

Time frame

Main Objective: The aim of the present study is to compare the effect of local application of Qutenza® patches covering trigger points in patients with chronic pain after surgery compared to placebo patches. The effects are monitored on pain at rest and during movement, areas of pin-prick hyperalgesia and brush allodynia, detection and pain thresholds for cold and heat within these areas. Our hypothesis is that small local Qutenza® patches applied over trigger points may reduce pain at rest, during movement and decrease sensory disturbances compared with a placebo patch. The present study is a pilot study performed in order to obtain proof of con-cept for a future comparative study between small localized and large Qutenza patches. ;Secondary Objective: Not applicable;Primary end point(s): • Difference in mean changes from baseline in pain score between active and placebo treatment at times day 14, 28 and 90 on a visual analogue scale (VAS 0-100 mm 0 is no pain and 100 is worst possible pain). • Difference in changes from baseline of area of pin-prick hyperalgesia, cold allodynia and brush allodynia assessed using von Frey filament 60 gram, Lindblom roller and Somedic Brush, between active and placebo treatment on day 14, day 28 and day 90. • Difference from baseline in detection, thresholds and tolerance for cold and warmth with-in the hyperalgesia area compared to normal skin, between active and placebo treatment on day 14, day 28 and day 90. If pain relief persists assessments are performed every 14 days.;Timepoint(s) of evaluation of this end point: Day 14, 28 and day 90

—

Secondary

Measure	Time frame
Secondary end point(s): • Time used to perform the treatment procedure from preparation of the patch to end of cleansing procedure • Difference in pain and discomfort between active and placebo during treatment at 15, 30, 45 and 60 minutes and after treatment assessed on a VAS scale 0-100 mm, 0 is no pain/discomfort, 100 is worst possible pain/discomfort • Difference in application site erythema, burning sensations, edema, pruritus, pap-ules/vesicles measured on a scale from none, slight, moderate to severe, between ac-tive and placebo treatment assessed at 15, 30, 45 and 60 minutes and 30 minutes after treatment in both groups • Irritation in eyes and throat, and coughing associated to the treatment assessed dur-ing and 30 minutes after treatment in both groups ;Timepoint(s) of evaluation of this end point: 15, 30, 45 and 60 minutes	—

Measure

Time frame

Secondary end point(s): • Time used to perform the treatment procedure from preparation of the patch to end of cleansing procedure • Difference in pain and discomfort between active and placebo during treatment at 15, 30, 45 and 60 minutes and after treatment assessed on a VAS scale 0-100 mm, 0 is no pain/discomfort, 100 is worst possible pain/discomfort • Difference in application site erythema, burning sensations, edema, pruritus, pap-ules/vesicles measured on a scale from none, slight, moderate to severe, between ac-tive and placebo treatment assessed at 15, 30, 45 and 60 minutes and 30 minutes after treatment in both groups • Irritation in eyes and throat, and coughing associated to the treatment assessed dur-ing and 30 minutes after treatment in both groups ;Timepoint(s) of evaluation of this end point: 15, 30, 45 and 60 minutes

—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026