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Mannitol Cream for Post Herpetic Neuralgia (MannitolPHN)

Primary Purpose

Neuralgia, Postherpetic

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Mannitol cream
Placebo
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia, Postherpetic focused on measuring Mannitol, cream, neuropathic pain

Eligibility Criteria

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

Inclusion Criteria

  1. - Suffering from post-herpetic neuralgia on the trunk or the extremities for at least three months.
  2. - Maximum daily pain score greater than or equal to 5/10.
  3. - Having failed to improve with at least one neuropathic pain medication.

4- Able and willing to fill a fluid survey NRS pain scale and a medication intake questionnaire daily, preferably online but on paper, if unable, for the first 24 days of the study, then once a month for three months..

5 - Preferably have access to someone who can apply cream to their back if they have pain in the back and cannot reach the area.

6 - If that is not possible, ability to apply the cream to their own back, using an applicator which will be supplied.

Exclusion Criteria:

  1. Allergies to any of the ingredients of the cream
  2. Open lesions or abrasions on the skin where the cream will be applied
  3. Using corticosteroids
  4. Unwilling to stop using other topical products (creams or patches) for the treatment of post-herpetic neuralgia
  5. Pregnant, breast-feeding or not using birth control
  6. Suffering from severe chronic pain from a cause other than post-herpetic neuralgia

    -

Sites / Locations

  • Dr. Helene Bertrand Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

mannitol in vehicle cream /vehicle cream

vehicle cream /mannitol in vehicle cream

Arm Description

one week on the mannitol cream (mannitol 30% in vehicle cream), a 3 day washout period, and one week on the placebo cream (vehicle cream alone). To be applied over the painful area as needed for pain. Usual frequency is 2 to 3 times daily.

one week on the placebo cream (vehicle cream alone), a 3 day washout period, and one week on the mannitol cream (mannitol 30% in vehicle cream).To be applied over the painful area as needed for pain. Usual frequency is unknown.

Outcomes

Primary Outcome Measures

Change in worst NRS (Numerical Rating Scale) pain score
In the last 24 hours, how bad was your pain at its worst? No pain 0 1 2 3 4 5 6 7 8 9 10 Worst pain imaginable
Change in average NRS (Numerical Rating Scale) pain score
In the last 24 hours, how bad was your pain on average? No pain 0 1 2 3 4 5 6 7 8 9 10 Worst pain imaginable

Secondary Outcome Measures

Change in Pain medication intake
Number of pills taken for pain in one day. Will decrease as the pain intensity decreases. Write the number of tablets that you took: 1. Tylenol/acetaminophen______, 2. Anti-inflammatory medication like Advil/ibuprofen, naproxen, diclofenac, Voltaren, Aleve______, 3. Tylenol or ASA (acetylsalicylic acid) plus narcotic like Tylenol 3, or 292 or Tramacet (acetaminophen/tramadol) ______, 4. Narcotic like morphine, hydromorphone/dilaudid, fentanyl, Demerol, tramadol______, 5. Cannabis, marijuana, or pot______, The total in each category will be added to calculate the total number of tablets taken in 24 hours.
Change in Alcohol intake
Number of alcoholic drinks in one day. May decrease as the pain intensity decreases. Write down the total number of alcoholic drinks you had in the last 24 hours:how many glasses of wine ______ glasses of hard liquor______ bottles of beer______. The total number of glasses will be recorded.
Change in questions from the brief pain inventory score
The total from the following questions will be recorded to measure how much their pain is interfering with their lives: Circle one number. In the last 24 hours, how much has your pain interfered with your: General activity:, Mood: Walking ability: Normal work: (includes both work outside the home and housework) Relations with other people: Sleep: Enjoyment of life: Each of these will be scored as follows: does not interfere 0 1 2 3 4 5 6 7 8 9 10 completely interferes. The scores added up. This sum should decrease as the pain decreases.
Change in PHQ-9 (Personal health questionnaire, 9 questions) Score
Patients will fill the PHQ - 9 score. http://phqscreeners.com/pdfs/02_PHQ-9/English.pdf The sum of the answers from this questionnaire, which is used to measure the degree of depression, may decrease as the pain intensity decreases.
Change in Method of cream application
Patients will describe whether they use cling wrap (4), gentle applicator (3) or rubbing in gently (2) or vigourous rubbing (1)
Change in effect and side effects of the cream
How many times did you apply the cream today?_______ Circle one number. How bad was your pain?.. Before you applied the cream? NRS 0-10 1hour after you applied the cream? NRS 0-10 Did the cream relieve your pain? No □ if Yes □ in how many minutes?____ For how many hours was your pain relieved?____ Did you experience a side effect from the cream? No □ if Yes □ What was it?_________________ Any comments?_______________________
Satisfaction from cream use
How satisfied were you with the use of this cream? Not at all satisfied 0 1 2 3 4 5 6 7 8 9 10 extremely satisfied
Change in pain score from mannitol cream use to mannitol and menthol cream use
Maximum pain score after 3 months of mannitol cream use compared to maximum pain score after one month of mannitol and menthol cream use

Full Information

First Posted
June 13, 2015
Last Updated
October 21, 2018
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02484170
Brief Title
Mannitol Cream for Post Herpetic Neuralgia
Acronym
MannitolPHN
Official Title
Mannitol Cream in the Treatment of Post-herpeticNeuralgia;a Randomized Placebo-Controlled Crossover Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 30, 2015 (undefined)
Primary Completion Date
April 29, 2016 (Actual)
Study Completion Date
April 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
30% mannitol cream has shown its ability to reduce the activation of the Capsaicin (TRPV1) (Transient Receptor Potential Vanilloid 1) receptor, a likely cause of the pain of post-herpetic neuralgia (PHN). This randomized placebo-controlled crossover study compares PHN pain one week before, for one week on the randomly assigned mannitol versus placebo cream and, after a three day washout, for one week on the other cream. Following this crossover study, participants receive mannitol cream for three months. Pain levels will be checked to assess whether continued use of this cream significantly reduces the pain levels associated with PHN. If pain persists beyond 3 months, participants will be offered mannitol and menthol cream for one month following which their pain levels will be checked.
Detailed Description
Pain levels: 0 to 10 Numerical Rating Scale (NRS), medication and alcohol intake will be checked daily for one week prior to randomization in 20 participants with post herpetic neuralgia, lasting more than three months. Following this 10 will be randomized to apply 30% mannitol in vehicle cream and 10 to apply vehicle cream alone for one week during which daily pain levels and use of medication and alcohol will be measured together with the mode of application (rubbing in or applying it to cling wrap then applying the cream coated cling wrap to the skin in cases of severe allodynia). After a three day washout period, they will be given the cream they did not receive previously for one week. The same variables will be recorded daily. The data collected in the first 24 days will be used to generate a power analysis. Following this, all subjects will receive the 30% mannitol cream to apply for three months. Their pain levels, medication intake and method of application will be measured once a month for three months. T-tests will compare the pain levels for mannitol and placebo users before and after one week of the use of each cream to see if the mannitol cream provides better short term pain relief than placebo. Repeated measures ANOVA (Analysis Of VAriance) will compare pain levels before using the mannitol cream and monthly for three months to assess the long-term effects of mannitol cream. Variables collected at each visit, which will not be used for statistical purposes in the current very small pilot project but may be used in a later study, include: application method, effect and side effects of the cream, medication and alcohol use, PHQ - 9 (Personal Health Questionnaire, 9 questions), and questions from the brief pain inventory score. At three months, a satisfaction score will be added to the database. If pain persists beyond 3 months, participants will be offered mannitol and menthol cream for one month, following which their pain levels, PHQ - 9 and brief pain inventory scores will be checked.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Postherpetic
Keywords
Mannitol, cream, neuropathic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
1 week observation, one week cream A assigned, 3 day crossover, one week of cream B assigned. After the crossover study, 3 months of mannitol cream assigned.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mannitol in vehicle cream /vehicle cream
Arm Type
Active Comparator
Arm Description
one week on the mannitol cream (mannitol 30% in vehicle cream), a 3 day washout period, and one week on the placebo cream (vehicle cream alone). To be applied over the painful area as needed for pain. Usual frequency is 2 to 3 times daily.
Arm Title
vehicle cream /mannitol in vehicle cream
Arm Type
Active Comparator
Arm Description
one week on the placebo cream (vehicle cream alone), a 3 day washout period, and one week on the mannitol cream (mannitol 30% in vehicle cream).To be applied over the painful area as needed for pain. Usual frequency is unknown.
Intervention Type
Drug
Intervention Name(s)
Mannitol cream
Other Intervention Name(s)
Mannitol in vehicle cream, QR cream
Intervention Description
Apply to area of postherpetic neuralgia pain as needed for pain control. Usual frequency is 2 to 3 times per day.For crossover study, will be applied for 7 days. For observational study, will be applied up to 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Vehicle cream
Intervention Description
Apply to area of postherpetic neuralgia pain as needed for pain control.Usual frequency is unknown. For crossover study, will be applied for 7 days. Will not be used after crossover study
Primary Outcome Measure Information:
Title
Change in worst NRS (Numerical Rating Scale) pain score
Description
In the last 24 hours, how bad was your pain at its worst? No pain 0 1 2 3 4 5 6 7 8 9 10 Worst pain imaginable
Time Frame
Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
Title
Change in average NRS (Numerical Rating Scale) pain score
Description
In the last 24 hours, how bad was your pain on average? No pain 0 1 2 3 4 5 6 7 8 9 10 Worst pain imaginable
Time Frame
Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
Secondary Outcome Measure Information:
Title
Change in Pain medication intake
Description
Number of pills taken for pain in one day. Will decrease as the pain intensity decreases. Write the number of tablets that you took: 1. Tylenol/acetaminophen______, 2. Anti-inflammatory medication like Advil/ibuprofen, naproxen, diclofenac, Voltaren, Aleve______, 3. Tylenol or ASA (acetylsalicylic acid) plus narcotic like Tylenol 3, or 292 or Tramacet (acetaminophen/tramadol) ______, 4. Narcotic like morphine, hydromorphone/dilaudid, fentanyl, Demerol, tramadol______, 5. Cannabis, marijuana, or pot______, The total in each category will be added to calculate the total number of tablets taken in 24 hours.
Time Frame
Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3,months
Title
Change in Alcohol intake
Description
Number of alcoholic drinks in one day. May decrease as the pain intensity decreases. Write down the total number of alcoholic drinks you had in the last 24 hours:how many glasses of wine ______ glasses of hard liquor______ bottles of beer______. The total number of glasses will be recorded.
Time Frame
Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
Title
Change in questions from the brief pain inventory score
Description
The total from the following questions will be recorded to measure how much their pain is interfering with their lives: Circle one number. In the last 24 hours, how much has your pain interfered with your: General activity:, Mood: Walking ability: Normal work: (includes both work outside the home and housework) Relations with other people: Sleep: Enjoyment of life: Each of these will be scored as follows: does not interfere 0 1 2 3 4 5 6 7 8 9 10 completely interferes. The scores added up. This sum should decrease as the pain decreases.
Time Frame
Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
Title
Change in PHQ-9 (Personal health questionnaire, 9 questions) Score
Description
Patients will fill the PHQ - 9 score. http://phqscreeners.com/pdfs/02_PHQ-9/English.pdf The sum of the answers from this questionnaire, which is used to measure the degree of depression, may decrease as the pain intensity decreases.
Time Frame
Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
Title
Change in Method of cream application
Description
Patients will describe whether they use cling wrap (4), gentle applicator (3) or rubbing in gently (2) or vigourous rubbing (1)
Time Frame
when each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
Title
Change in effect and side effects of the cream
Description
How many times did you apply the cream today?_______ Circle one number. How bad was your pain?.. Before you applied the cream? NRS 0-10 1hour after you applied the cream? NRS 0-10 Did the cream relieve your pain? No □ if Yes □ in how many minutes?____ For how many hours was your pain relieved?____ Did you experience a side effect from the cream? No □ if Yes □ What was it?_________________ Any comments?_______________________
Time Frame
Daily for the 14 days, of the crossover study, then at 1,2 and 3 months
Title
Satisfaction from cream use
Description
How satisfied were you with the use of this cream? Not at all satisfied 0 1 2 3 4 5 6 7 8 9 10 extremely satisfied
Time Frame
Three months after use of mannitol cream was started.
Title
Change in pain score from mannitol cream use to mannitol and menthol cream use
Description
Maximum pain score after 3 months of mannitol cream use compared to maximum pain score after one month of mannitol and menthol cream use
Time Frame
1st measurement Three months after use of mannitol cream was started 2nd measurement one month after mannitol and menthol cream started

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria - Suffering from post-herpetic neuralgia on the trunk or the extremities for at least three months. - Maximum daily pain score greater than or equal to 5/10. - Having failed to improve with at least one neuropathic pain medication. 4- Able and willing to fill a fluid survey NRS pain scale and a medication intake questionnaire daily, preferably online but on paper, if unable, for the first 24 days of the study, then once a month for three months.. 5 - Preferably have access to someone who can apply cream to their back if they have pain in the back and cannot reach the area. 6 - If that is not possible, ability to apply the cream to their own back, using an applicator which will be supplied. Exclusion Criteria: Allergies to any of the ingredients of the cream Open lesions or abrasions on the skin where the cream will be applied Using corticosteroids Unwilling to stop using other topical products (creams or patches) for the treatment of post-herpetic neuralgia Pregnant, breast-feeding or not using birth control Suffering from severe chronic pain from a cause other than post-herpetic neuralgia -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene Bertrand, MD, CM, CCFP
Organizational Affiliation
University of British Columbia, Department of family practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Helene Bertrand Inc.
City
North Vancouver
State/Province
British Columbia
ZIP/Postal Code
V7M 2K2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25978942
Citation
Bertrand H, Kyriazis M, Reeves KD, Lyftogt J, Rabago D. Topical Mannitol Reduces Capsaicin-Induced Pain: Results of a Pilot-Level, Double-Blind, Randomized Controlled Trial. PM R. 2015 Nov;7(11):1111-1117. doi: 10.1016/j.pmrj.2015.05.002. Epub 2015 May 12.
Results Reference
background
PubMed Identifier
25841257
Citation
Gilron I, Baron R, Jensen T. Neuropathic pain: principles of diagnosis and treatment. Mayo Clin Proc. 2015 Apr;90(4):532-45. doi: 10.1016/j.mayocp.2015.01.018.
Results Reference
background
PubMed Identifier
22610112
Citation
Shannon HJ, Anderson J, Damle JS. Evidence for interventional procedures as an adjunct therapy in the treatment of shingles pain. Adv Skin Wound Care. 2012 Jun;25(6):276-84; quiz 285-6. doi: 10.1097/01.ASW.0000415345.22307.f3.
Results Reference
background
PubMed Identifier
23068431
Citation
Szolcsanyi J, Sandor Z. Multisteric TRPV1 nocisensor: a target for analgesics. Trends Pharmacol Sci. 2012 Dec;33(12):646-55. doi: 10.1016/j.tips.2012.09.002. Epub 2012 Oct 12.
Results Reference
background

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Mannitol Cream for Post Herpetic Neuralgia

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