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Phantom Limb Pain (PLP)Phase 2NCT02696720

A Trial of Lidocaine Patch for Lower Limb Amputation Pain

A Phase 2 study testing Lidocaine in people with Phantom Limb Pain (PLP) and Primary/Secondary Scar Hyperalgesia, run by Brugmann University Hospital at 2 sites in Belgium.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Phantom limb pain (PLP) and scar hyperalgesia (SH) are frequent problems after amputation; in particular most persons who undergo limb amputation will experience phantom pain. The neuropathic nature of PLP suggests the involvement of both peripheral and central neurological mechanisms, including neuroplastic changes… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lidocaine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
2 sitesBelgium
Study dates
13 May 2016to 13 Jun 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All above or below knee amputations , two months or more after surgery, after complete wound healing (no clips, no stitches, no seepage)

Who cannot join

  • History of central nervous system disease
  • History of major psychiatric disease (MMS<23/30, HADS>8/21)
  • Pregnancy
  • Known hypersensitivity to local anesthetics (lidocaine, bupivacaine, etidocaine, mepivacaine, prilocaine)
  • skin irritation on the stump

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • CHU Brugmann - Queen Astrid

    Brussels

  • Erasme -CTR

    Brussels

Other trials in Belgium

About this study

Official title: A Randomized Controlled Trial of Lidocaine Patch for Lower Limb Amputation Pain

Phantom limb pain (PLP) and scar hyperalgesia (SH) are frequent problems after amputation; in particular most persons who undergo limb amputation will experience phantom pain. The neuropathic nature of PLP suggests the involvement of both peripheral and central neurological mechanisms, including neuroplastic changes in the central nervous system. PLP as other central nervous system-related pain syndromes remains a challenge for treatment. Scar hyperalgesia involves peripheral mechanisms and results frim the production of substances liberated by damaged skin cells. These inflammatory substances lower the pain threshold by altering the chemical environment of skin nerve endings. Scan hyperalgesia is associated with secondary mechanical hyperalgesia in the skin area around the scar.

The lidocaine patch 5% is a topical analgesic acting by blocking sodium channels of peripheral nerve endings and by inhibiting ectopic discharges in sensitized and hyperactive cutaneous nociceptors. The patch is noninvasive, with minimal systemic absorption resulting in a reduced risk of drug-drug interaction. In addition, a central analgesic effect of lidocaine has been suggested. The lidocaine patch 5% is currently licensed for the treatment of symptomatic postherpetic neuralgia. It also has been successfully used in patients with other neuropathic pain states, such as entrapment neuropathies, painful idiopathic distal sensory polyneuropathies and postoperative/post traumatic neuropathic chronic cutaneous pain. The lidocaine patch has not been studied for the management and prevention of phantom limb pain.

Read more

The aim of the present research is to investigate if a lidocaine patch 5% is effective for reducing PLP and primary/secondary scar hyperalgesia. The hypothesis is that persistent peripheral nociceptive input from the stump after surgery may drive maladaptive cortical reorganization leading to chronic central pain and thus promote chronic phantom limb pain. Treating scar hyperalgesia on the stump with topical lidocaine may reduce the activity of peripheral nociceptive afferents and thus decrease the likelihood of developing persistent phantom limb pain.

This study is designed as a randomized controlled multicentric double blind trial, in which the effectiveness of applying a 5% lidocaine patch for 6 weeks will be compared with a sham.

Being tested
Lidocaine, Sham
Keywords
lidocaine, phantom limb pain (PLP), Primary/secondary scar hyperalgesia
Medical subject headings
Phantom Limb

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02696720
Study groupRoleWhat they receive
LidocaineExperimentalDuring a period of six weeks, a lidocaine patch will be applied around the wound (cut in two parts, 1cm above and below the wound, without direct contact with the scar) for a total of twelve hours per day, during night time.
Receives: Drug: Lidocaine
ShamSham comparatorDuring a period of six weeks, a visually identical patch (sham) will be applied around the wound (cut in two parts, 1cm above and below the wound, without direct contact with the scar) for a total of twelve hours per day, during night time.
Receives: Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-reported overall daily pain intensity

    The overall daily pain intensity (stump, scar and phantom pain combined) will be rated on a 0 to 100 visual analogue scale with anchors of 0 (no pain) to 100 (worst pain ever experienced).

    Measured: Daily, starting seven days before patch placement (baseline) till six weeks after patch placement

Secondary outcomes (20)

  1. Neuropathic Pain (DN4)

    Screening for neuropathic pain, by using the DN4 questionnaire

    Measured: at baseline - 7 days before patch placement

  2. Neuropathic pain

    Rated with the Neuropathic Pain Symptom Inventory

    Measured: at baseline - 7 days before patch placement

  3. Neuropathic pain

    Rated with the Neuropathic Pain Symptom Inventory

    Measured: One day after patch placement

  4. Neuropathic pain

    Rated with the Neuropathic Pain Symptom Inventory

    Measured: 6 weeks after patch placement

  5. Neuropathic pain

    Rated with the Neuropathic Pain Symptom Inventory

    Measured: 6 months after patch placement

  6. Pain (McGill)

    Rated by the Short-Form McGill Pain Questionnaire, sensitive to the effects of pain treatment.

    Measured: at baseline - 7 days before patch placement

  7. Pain (McGill)

    Rated by the Short-Form McGill Pain Questionnaire, sensitive to the effects of pain treatment.

    Measured: One day after patch placement

  8. Pain (McGill)

    Rated by the Short-Form McGill Pain Questionnaire, sensitive to the effects of pain treatment.

    Measured: 6 weeks after patch placement

  9. Quality of life

    Rated by the SF36 questionnaire

    Measured: at baseline -7 days before patch placement

  10. Quality of life

    Will be rated by the SF36 questionnaire

    Measured: six weeks after patch placement

  11. Quality of life

    Will be rated by the SF36 questionnaire

    Measured: six months after patch placement

  12. Sleep quality

    will be assessed with the Pittsburgh Sleep Quality index

    Measured: baseline -7 days before patch placement

  13. Sleep quality

    will be assessed with the Pittsburgh Sleep Quality index

    Measured: 6 weeks after patch placement

  14. Sleep quality

    will be assessed with the Pittsburgh Sleep Quality index

    Measured: 6 months after patch placement

  15. Delay of dress of provisory prosthesis

    Number of days between surgery and delivery of temporary prosthesis

    Measured: From the day of the surgery till the day of the delivery of temporary prosthesis, for a maximum of 6 months

  16. Delay of dress of provisory prosthesis

    Number of days between inclusion in the research protocol and delivery of temporary prosthesis

    Measured: From the day of patient inclusion in the research protocol till the day of the delivery of temporary prosthesis, for a maximum of 6 months

  17. Cumulative analgesic consumption (morphine equivalents)

    Rated by the cumulative analgesic consumption score (CACS)

    Measured: baseline -7 days before patch placement

  18. Cumulative analgesic consumption (morphine equivalents)

    Rated by the cumulative analgesic consumption score (CACS)

    Measured: 1 day after patch placement

  19. Cumulative analgesic consumption (morphine equivalents)

    Rated by the cumulative analgesic consumption score (CACS)

    Measured: 6 weeks after patch placement

  20. Phantom Limb Pain occurence

    occurence of phantom limb pain

    Measured: 6 months after patch placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2016 (estimated)
  2. Study start13 May 2016
  3. Primary completion13 Jun 2017
  4. Study completion13 Jun 2017

Why it stopped: Lack of recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02696720
Sponsor's protocol ID
CHUB-patch lidocaine
Status last verified
Jan 2018
First submitted
26 Feb 2016
Last updated
23 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Robinson LR, Czerniecki JM, Ehde DM, Edwards WT, Judish DA, Goldberg ML, Campbell KM, Smith DG, Jensen MP. Trial of amitriptyline for relief of pain in amputees: results of a randomized controlled study. Arch Phys Med Rehabil. 2004 Jan;85(1):1-6. doi: 10.1016/s0003-9993(03)00476-3.

    PubMed 14970960

  • HARDY JD, WOLFF HG, GOODELL H. Experimental evidence on the nature of cutaneous hyperalgesia. J Clin Invest. 1950 Jan;29(1):115-40. doi: 10.1172/JCI102227. No abstract available.

    PubMed 15399521

  • Gammaitoni AR, Alvarez NA, Galer BS. Safety and tolerability of the lidocaine patch 5%, a targeted peripheral analgesic: a review of the literature. J Clin Pharmacol. 2003 Feb;43(2):111-7. doi: 10.1177/0091270002239817.

    PubMed 12616661

  • Koppert W, Ostermeier N, Sittl R, Weidner C, Schmelz M. Low-dose lidocaine reduces secondary hyperalgesia by a central mode of action. Pain. 2000 Mar;85(1-2):217-24. doi: 10.1016/s0304-3959(99)00268-7.

    PubMed 10692621

  • Nalamachu S, Crockett RS, Gammaitoni AR, Gould EM. A comparison of the lidocaine patch 5% vs naproxen 500 mg twice daily for the relief of pain associated with carpal tunnel syndrome: a 6-week, randomized, parallel-group study. MedGenMed. 2006 Aug 9;8(3):33.

    PubMed 17406167

  • Herrmann DN, Barbano RL, Hart-Gouleau S, Pennella-Vaughan J, Dworkin RH. An open-label study of the lidocaine patch 5% in painful idiopathic sensory polyneuropathy. Pain Med. 2005 Sep-Oct;6(5):379-84. doi: 10.1111/j.1526-4637.2005.00058.x.

    PubMed 16266359

  • Hans G, Joukes E, Verhulst J, Vercauteren M. Management of neuropathic pain after surgical and non-surgical trauma with lidocaine 5% patches: study of 40 consecutive cases. Curr Med Res Opin. 2009 Nov;25(11):2737-43. doi: 10.1185/03007990903282297.

    PubMed 19788351

  • Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. doi: 10.1016/j.pain.2004.12.010. Epub 2005 Jan 26.

    PubMed 15733628

  • Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.

    PubMed 15030944

  • Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.

    PubMed 3670870

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

    PubMed 2748771

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lidocaine in people with Phantom Limb Pain (PLP) and Primary/Secondary Scar Hyperalgesia, run by Brugmann University Hospital at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-reported overall daily pain intensity (time frame: Daily, starting seven days before patch placement (baseline) till six weeks after patch placement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02696720, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.

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