Phantom Limb Pain (PLP) Clinical Trial
Official title:
A Randomized Controlled Trial of Lidocaine Patch for Lower Limb Amputation Pain
| Verified date | January 2018 |
| Source | Brugmann University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 13, 2017 |
| Est. primary completion date | June 13, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - All above or below knee amputations , two months or more after surgery, after complete wound healing (no clips, no stitches, no seepage) Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | CHU Brugmann - Queen Astrid | Brussels | |
| Belgium | Erasme -CTR | Brussels |
| Lead Sponsor | Collaborator |
|---|---|
| Brugmann University Hospital |
Belgium,
Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lantéri-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. Epub 2005 Jan 26. — View Citation
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):248-57. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
HARDY JD, WOLFF HG, GOODELL H. Experimental evidence on the nature of cutaneous hyperalgesia. J Clin Invest. 1950 Jan;29(1):115-40. — View Citation
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. — View Citation
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. — View Citation
Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-7. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | Daily, starting seven days before patch placement (baseline) till six weeks after patch placement | |
| Secondary | Neuropathic Pain (DN4) | Screening for neuropathic pain, by using the DN4 questionnaire | at baseline - 7 days before patch placement | |
| Secondary | Neuropathic pain | Rated with the Neuropathic Pain Symptom Inventory | at baseline - 7 days before patch placement | |
| Secondary | Neuropathic pain | Rated with the Neuropathic Pain Symptom Inventory | One day after patch placement | |
| Secondary | Neuropathic pain | Rated with the Neuropathic Pain Symptom Inventory | 6 weeks after patch placement | |
| Secondary | Neuropathic pain | Rated with the Neuropathic Pain Symptom Inventory | 6 months after patch placement | |
| Secondary | Pain (McGill) | Rated by the Short-Form McGill Pain Questionnaire, sensitive to the effects of pain treatment. | at baseline - 7 days before patch placement | |
| Secondary | Pain (McGill) | Rated by the Short-Form McGill Pain Questionnaire, sensitive to the effects of pain treatment. | One day after patch placement | |
| Secondary | Pain (McGill) | Rated by the Short-Form McGill Pain Questionnaire, sensitive to the effects of pain treatment. | 6 weeks after patch placement | |
| Secondary | Quality of life | Rated by the SF36 questionnaire | at baseline -7 days before patch placement | |
| Secondary | Quality of life | Will be rated by the SF36 questionnaire | six weeks after patch placement | |
| Secondary | Quality of life | Will be rated by the SF36 questionnaire | six months after patch placement | |
| Secondary | Sleep quality | will be assessed with the Pittsburgh Sleep Quality index | baseline -7 days before patch placement | |
| Secondary | Sleep quality | will be assessed with the Pittsburgh Sleep Quality index | 6 weeks after patch placement | |
| Secondary | Sleep quality | will be assessed with the Pittsburgh Sleep Quality index | 6 months after patch placement | |
| Secondary | Delay of dress of provisory prosthesis | Number of days between surgery and delivery of temporary prosthesis | From the day of the surgery till the day of the delivery of temporary prosthesis, for a maximum of 6 months | |
| Secondary | Delay of dress of provisory prosthesis | Number of days between inclusion in the research protocol and delivery of temporary prosthesis | 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 | |
| Secondary | Cumulative analgesic consumption (morphine equivalents) | Rated by the cumulative analgesic consumption score (CACS) | baseline -7 days before patch placement | |
| Secondary | Cumulative analgesic consumption (morphine equivalents) | Rated by the cumulative analgesic consumption score (CACS) | 1 day after patch placement | |
| Secondary | Cumulative analgesic consumption (morphine equivalents) | Rated by the cumulative analgesic consumption score (CACS) | 6 weeks after patch placement | |
| Secondary | Phantom Limb Pain occurence | occurence of phantom limb pain | 6 months after patch placement |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06077227 -
Immersive Healing: The Therapeutic Potential of Virtual Reality
|
N/A |