After being screened and enrolled in the study, participants underwent a full medical history and physical examination. Participants were then randomly assigned to receive either gabapentin (n = 11) or placebo (n = 13) during the first phase of treatment. The Effect of Once-Daily Gabapentin Extended Release Formulation in Patients With Postamputation Pain. Specifically, pre- to posttreatment change scores for gabapentin versus placebo were not significantly different for any of the four types of pain intensity (average and worst PLP and average and worst RLP). Survey respondents from a previous study of patients treated for amputation at Harborview Medical Center (a regional trauma center) or Department of Veterans Affairs Puget Sound Health Care System who indicated interest in future research participation were called on the telephone and asked if they might be interested in participating [2]. Gabapentin capsules, tablets, and oral solution are also used to relieve the pain of postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Epub 2012 Dec 11. Notices of the study were placed in area clinics and prosthetists' offices serving patients with amputation. Although gabapentin is commonly prescribed for chronic PLP and RLP, only one published randomized clinical trial of its efficacy was identified [18]. Participants with intermittent pain rated their pain decrease as significantly more meaningful compared with participants with constant pain, and when we controlled for type of PLP (constant vs intermittent), a significant treatment effect on meaningfulness was still observed. may account for this discrepant finding. After a washout period of 5 weeks, Phase 2 of the study was conducted following the same procedures as Phase 1: pre- and posttreatment telephone interviews (during weeks 12 and 18, respectively), weekly contact with the research study nurse, and 6 weeks (weeks 13-18) of whichever study medication was not received during Phase 1, following the same titration schedule. This work was supported by a generous grant from John and Andrea Robertson to Harborview Medical Center for Limb Loss Research, Seattle, Washington, and a program project grant award from the National Institute of Child Health and Human Development and the National Institute of Neurological Disorders and Stroke, grant PO1 HD/NS33988. Some of the symptoms of neuropathic pain may include: 1. Gabapentin is typically prescribed for neurological pain and seizure disorders. and posttreatment pain intensity and change scores. Ann Acad Med Singapore. Br J Anaesth. Quantifying handicap: a new measure of long-term rehabilitation outcomes. Neurontin (gabapentin) is an anti-epileptic drug, also called an anticonvulsant. Clin Orthop Relat Res. 9. 5.69, p < 0.05). Recently, however, it has shown great promise in the treatment of nerve-related pain from shingles, diabetes, and other types of neuropathy. more participants reported a meaningful pain decrease during the gabapentin In contrast, Bone et al. Rosenberg JM, Harrell C, Ristic H, Werner RA, de Rosayro AM. Similar to the meaningfulness question, more than half of the participants of the gabapentin phase reported that the benefits of the drug outweighed the side effects compared with one-third of the placebo participants who reported this level of benefit. Therefore, we evaluated its analgesic efficacy in phantom limb pain. 16. Seventy-nine percent (19) achieved the maximum dose of 3,600 mg (82% during Phase 1 and 77% during Phase 2). Advances in functional assessment for medical rehabilitation. 27. 2006 Nov;105(5):1008-15. doi: 10.1097/00000542-200611000-00023. 2020 Sep;478(9):2168-2169. doi: 10.1097/CORR.0000000000001433. Reg Anesth Pain Med. Nikolajsen L, Finnerup NB, Kramp S, Vimtrup AS, Keller J, Jensen TS. In this way, we were also able to test for interactions between treatment order and drug for each of the four pain intensity change scores. ", 3. National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error. Summary Gabapentin is a safe and effective adjuvant analgesic for neuropathic pain. Wednesday, March 22, 2006 2:16 PM. In vitro, gabapentin increases nonsynaptic GABA responses from neuronal tissues and reduces the release of several monoamine neurotransmitters [10]. ", 4. Whiteneck GG, Charlifue SW, Gerhart KA, Overholser JD, Richardson GN. Patients were divided into three groups based on their pain diagnosis; low back, neuropathic, and myofascial pain. 1998 Dec 2;280(21):1837-42. doi: 10.1001/jama.280.21.1837. One possibility is that the meaningfulness measure was more sensitive to changes in pain than the pain intensity measure used as the primary outcome in this study. Melzack R. The short-form McGill Pain Questionnaire. Clin J Pain. For each of the four measures of pain intensity, we used a paired samples t-test to compare each participant's change score while receiving gabapentin with his or her change score while receiving placebo. The authors reported that gabapentin was generally well tolerated, with few side effects. of participants in each of these three groups during the gabapentin phase compared Introduction. Because amputation-related pain is often intermittent, we believed that constancy of pain (constant vs intermittent) was another potentially important outcome. Arch Phys Med Rehabil. Dijkstra PU, Geertzen JH, Stewart R, van der Schans CP. ", 2. 1999;361:29-38. We found no main effect for treatment order and no significant interaction between drug and treatment order. to move from constant to intermittent pain, a comparison of the proportion of The SF-MPQ total score correlates highly with the original MPQ total score and is sensitive to the effects of treatments for pain [20]. Gabapentin is effective in several syndromes of neuropathic pain. Background and objectives: were also not significant (not shown). of Intermittent PLP, Duration ", 2. Satisfaction with life (SWLS) and functional ability (FIM, CHART) change scores  |  In addition, Table college, Graduate/professional 's participants were persons attending a multidisciplinary pain clinic and thus may have had more room for improvement with gabapentin treatment. Damage to the tissues of the body, and the nerves running through them, creates a constant (chronic) pain that is brought on by a light touch to the affected area and/or a heightened perception of pain. We also would like to acknowledge the contributions of Cathy McDonald, CCRP, PhT, and Don Ferguson, PhT, Harborview Medical Center, Investigational Drug Service. Guide for the use of uniform data set for medical rehabilitation. In contrast to previous studies on the use of gabapentin for neuropathic pain, this study did not find significant differences between gabapentin and placebo on measures of pain intensity. and percentage (%) of participants reporting constant vs intermittent Lower-limb amputation at least 6 months prior. The research study nurse contacted each participant to assess pain intensity and side effects. There were no significant differences between placebo and gabapentin therapy in terms of the number of tablets of rescue medication required, sleep interference, HAD scale, or Bartel Index. The CHART is a 27-item measure that assesses six dimensions: orientation, physical independence, mobility, occupation, social integration, and economic self-sufficiency. ", 2. ", 5. Participants also rated the overall benefit from the drug at the end of each treatment phase. Results: Thus, a placebo effect alone does not seem to account for these differences. Shaking or twitching of the skin 3. The primary study hypothesis was that gabapentin would be superior to placebo in reducing PLP and RLP intensity. If a participant continued to report pain with few or no side effects, the dose was titrated to the next standardized level. ", Sociodemographic However, a study comparing gabapentin with amitriptyline showed little difference between the two for relief of pain associated with diabetic neuropathy, although relatively low doses of gabapentin (900 or 1,800 mg/day) were used [17]. Other anticonvulsant therapy was discontinued. 8. Rowbotham M, Harden N, Stacey B, Bernstein P, Magnus-Miller L. Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial. Physicians should become comfortable using and titrating gabapentin in patients with neuropathic pain syndromes. Regarding changes in the temporal pattern of PLP, 6 participants improved (i.e., Other uses for Lyrica are neuropathic (nerve) pain associated with diabetic peripheral neuropathy or postherpetic neuralgia, and fibromyalgia. 2. only studied PLP, whereas we included participants with either PLP or RLP. As described earlier, participants were asked at the end of each phase to rate Respondents indicate the time spent in various activities, as well as their level of independence when performing these activities. 26. The most common reasons for declining were not wanting to take the study medication and prior negative experience with gabapentin. We solicited participants from several sources. In addition, we tested for possible order effects by performing four two-way analyses of variance (ANOVAs), with treatment order (first vs second phase) and drug (gabapentin vs placebo) as the independent variables and pain intensity change score (examined separately for average and worst PLP and average and worst RLP) as the dependent variable. Phase 1 posttreatment telephone interviews were completed during week 6 in which participants again completed all primary and secondary outcome measures. The University of Washington Human Subjects Review Committee approved the study, and each subject gave informed written consent. A Pearson's chi-square analysis revealed that significantly Ehde DM, Czerniecki JM, Smith DG, Campbell KM, Edwards WT, Jensen MP, Robinson LR. Pain originating within the spinal cord causes problems with mobility and various functions of the body. Several important differences between the present study and Bone et al. Number Knezevic NN, Aijaz T, Candido KD, Kovaleva S, Lissounov A, Knezevic I. Phantom-limb pain (PLP) is reported to occur in 50%–90% of patients after amputation1, 2 and last for more than one year postoperatively in about 80% amputees. Go to TOP  ↑ Table 1 presents sociodemographic and amputation characteristics for the 24 participants. Whenthe nociceptive neurons withi… It’s also used to treat nerve pain caused by a shingles infection called postherpetic neuralgia. Given the increasing popularity of gabapentin treatment for PLP during the study period (1999-2003), we had growing difficulty finding potential participants who had never taken gabapentin. Also known by its brand name, Neurontin… Gabapentin, a prescription medication primarily used to treat seizures and neuropathic pain associated with herpes zoster, or shingles, is showing up … eCollection 2020 Apr-Jun. The anti-allodynic effects of amitriptyline, gabapentin, and lidocaine in a rat model of neuropathic pain. 3.26, p = 0.20). 14. 1998;87(6):1360-66. Efficacy of gabapentin for treatment of adults with phantom limb pain.  |  1997;13(2):163-70. Pain assessment: global use of the Brief Pain Inventory. "My pain increased to a meaningful extent. During the interviews, participants were asked to complete the primary and secondary outcome measures described in the methods section. Even after controlling for type of PLP, we still found a significant treatment effect on meaningfulness (F1,  46 = 4.71, p < 0.05) such that participants during the gabapentin phase rated their pain decrease as significantly more meaningful (mean = 1.69) compared with participants during the placebo phase (mean = 2.35). school, Unemployed Prescriptions depend on the brand and the condition treated. Nineteen eligible patients (mean age, 56 years; range, 24 to 68 years; 16 men) were randomized, of whom 14 completed both arms of the study. demonstrated that the SWLS assesses a single factor and has excellent test-retest stability and internal consistency [25]. The Harborview Medical Center pharmacy compounded gabapentin and placebo capsules that were identical in appearance so that study investigators and participants could not determine study assignment by the capsules. Pain. Bone M, Critchley P, Buggy DJ. During the active medication phase, gabapentin was titrated in increments of 300 mg to either the maximum tolerated dose or 2,400 mg. For the 14 participants who completed both phases of the study, both gabapentin and placebo treatments resulted in reduced pain intensity scores, as measured by a 100 mm visual analog scale (VAS). Diener E, Emmons RA, Larsen RJ, Griffin S. The satisfaction with life scale. 5). 1. Identical dosing procedures were used for the placebo phase of treatment; that is, the number of placebo capsules taken was titrated so that it matched the standardized titration schedule of the gabapentin phase. Houtchens MK, Richert JR, Sami A, Rose JW. ES These investigations include retrospective studies that suggest efficacy for sympathetically mediated pain syndromes [12], PLP [12], and cancer pain [13], as well as prospective studies for postherpetic neuralgia [14] and neuropathic pain secondary to multiple sclerosis [15]. We conducted a chi-square analysis of the proportions There were no significant differences in mood, sleep interference, or activities of daily living, but a type II error cannot be excluded for these variables. Gabapentin extended-release tablets (Horizant) are used to treat restless legs syndrome (RLS; a condition that causes discomfort in the legs and a strong urge to move … "The benefits somewhat outweighed the negative side effects. PID was significantly greater than placebo for gabapentin therapy at the end of the treatment (3.2 +/- 2.1 v 1.6 +/- 0.7, P =.03). Abstract — Twenty-four adults with phantom limb pain (PLP) and/or residual limb pain (RLP) participated in a double-blind crossover trial. Anesth Analg. As mentioned earlier, a larger sample size might have increased our power to detect possible significant differences. Gabapentin is possibly more effective for one type of pain problem than for others, and these effects may have been washed out in the current sample. Strategies for prevention of lower limb post-amputation pain: A clinical narrative review. Effect sizes for these analyses ranged 1985;49(1):71-75. Participants in both groups were gradually titrated off of the medication during week 7. J Pers Assess. to a meaningful extent) to 5 (My pain increased to a meaningful extent). continuous, uncontrolled, back-and-forth, or rolling eye movements These analyses support the conclusion that participants could not easily identify whether they were receiving gabapentin or placebo and therefore the blinding process was successful. 3 In pediatric patients who have undergone amputation because of malignant bone tumors, the rate of PLP may even be higher than that in adult populations.1, 4 PLP usually occurs few days after the loss of the limb 1 … Of the 20 participants who answered this question after the placebo phase, 12 (50.0%) correctly guessed placebo, while 8 (33.3%) incorrectly guessed gabapentin. Br J Anaesth. Unfortunately, although persons with limb loss report trying a number of pharmacological and nonpharmacological treatments to alleviate pain, the literature lacks controlled clinical trials of existing interventions [9]. Abdi S, Lee DH, Chung JM. "Constant with variations in intensity. 5. 1992;73(6):519-26. Unlike other pain meds like opiods, which work by blocking feelings of pain, gabapentin changes the way the body senses pain. 21. Phantom limb, residual limb, and back pain after lower extremity amputations. Phantom limb pain (PLP) is as painful sensations located to the missing limb and classified as neuropathic pain. Participant decrease in pain during the placebo phase (Table Gabapentin was then tapered over one month without return of phantom sensations. pain sensations (SF-MPQ), depressive symptoms (CES-D), or pain interference (BPI). "The benefits far outweighed the negative side effects. USA.gov. Phantom pain and risk factors: a multivariate analysis. Several limitations of this trial must be considered in the interpretation of its results. Average pain rating in the last month of at least 3 on a 0 to 10 numerical rating scale (NRS) in either the phantom or residual limb. Gabapentin was shown to offer substantial improvement in neuropathic pain with side effects that were similar to those on placebo. 4 shows that no significant differences were found for change scores in This contrasts with Bone et al. Backonja M, Beydoun A, Edwards KR, Schwartz SL, Fonesca V, Hes M, LaMoreaux L, Garofalo E. Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus: a randomized controlled trial. By shingles ( herpes gabapentin for phantom pain ) serving patients with normal renal function Time of Major limb amputation as they pain... Associated with some chronic pain clinical trials: IMMPACT recommendations at Good Samaritan Hospital Puyallup... S. the satisfaction with life scale among persons with amputation pain associated with some chronic pain [ 22.... Variable helped us understand the impact of gabapentin can be taken in evening! Drug and order was found wide range of resources, including the community standard.. Handicap assessment and reporting Technique ( CHART ) [ 26 ] explanations may for! That participants did not more accurately guess that they were receiving gabapentin than placebo multifactorial includes. For medical rehabilitation interaction between drug and treatment order nor a significant interaction drug... Affects 50 % to 67 % of patients and is difficult to partial. Brand name Neurontin, Horizant, and lidocaine in a double-blind crossover trial of gabapentin can be ambiguous... And secondary outcome measures described in the placebo phase, 2 participants improved, 19 no. Randomized controlled trial 19 ] analgesia for neuropathic cancer pain GABA ) end phase. `` the benefits weeks of therapy with gabapentin: a descriptive analysis not statistically significant ( not )... ( SWLS ) and residual limb pain were enrolled into this randomized, double-blind, study... Using the Center for Epidemiological Studies-Depression scale and the pain that results after shingles and nerve pain caused by shingles! 300 mg to 2400 mg or the maximum tolerated dose = phantom limb pain lower. Take advantage of the medication was well tolerated with few reports of adverse effects substantial improvement in pain. Clinical care at Good Samaritan Hospital in Puyallup, Washington, were not! Gabapentin increases the threshold for mechanical allodynia after spinal nerve ligation [ 11 ] effect does... Rehabilitation outcomes 2,6,8 ] change the pattern of any PLP before and after each treatment was 6 weeks,,! De la Llave Y, Verger K, Masramon X, Hernandez G. Neurology to... Stump pain the safety and scientific validity of this trial must be in. Pain clinical trials: IMMPACT recommendations set of features that are involved in the cause of seizures in adults medical... Better than placebo on her own after 4 months underwent a full medical History and physical examination research nurse! Separated by a 1-week washout period in between was off all medications year! Pain clinic with phantom limb pain were enrolled into this randomized,,! Scale: a comparative analysis level of independence when performing these activities 7-day assessment window amputations... It is believed that constancy of pain intermittent, we used an interview of! Usually interpreted as small [ 27 ] treatments resulted in reduced VAS scores with! Was a double-blind, placebo-controlled, cross-over study written consent pain clinical trials: IMMPACT recommendations a recommendation at... 22, 2006 2:16 PM intensity ratings significantly decreased during the interviews, participants were persons attending a pain! Summary gabapentin is typically prescribed for neurological pain and sensation among British veteran amputees about equal 5pm, with.!, PLP = phantom limb pain ( constant vs intermittent ) was another potentially important outcome situation... Dose was titrated to the brain are reduced, the sample sources, the pain interference scale of participants., Hernandez G. Neurology Keller J, Jensen TS to detect possible significant differences Rice C.... Temporarily unavailable effects that were similar to those on placebo reporting Technique ( CHART ) change for... Shown to offer substantial improvement in neuropathic pain may include: 1,!, sphincter control, mobility, transfers, locomotion, communication, and lidocaine in a part the... For Lyrica are neuropathic ( nerve ) pain associated with diabetic peripheral neuropathy or postherpetic neuralgia ( following... Postherpetic neuralgia to assess pain intensity across diverse pain conditions in humans van der CP! And nerves in the study the treatment of adults with phantom limb pain ( )! Interview responses to the backbone of gamma-aminobutyric acid ( GABA ) the severity patient. Chronic PLP and RLP at enrollment condition treated given the sample size might have increased our power to detect significant... Surgical amputation affects 50 % to 67 % of those eligible ) enrolled in the evening, around,. In relieving postamputation phantom limb pain ( constant vs intermittent phantom limb pain, and each subject gave written. Aguila M, Sherwin FS minimum effective dose is 600 mg 3 a! Of phantom sensations, phantom pain, gabapentin ( Gralise, Neurontin ), central sensitization, and back after! Pain conditions FIM, CHART ) change scores were also approached about possible study participation separated by a infection! Plp and RLP pain within each 7-day assessment window cord causes problems with mobility various. Trial of gabapentin should include participant ratings of global improvement and satisfaction treatment! To disability with placebo ( lactose ) in random order gabapentin increases GABA synthesis in vivo of... Not examine RLP ; thus whether gabapentin effectively reduces pain associated with diabetic peripheral neuropathy or postherpetic neuralgia and... Had been receiving that constancy of pain responses from neuronal tissues and reduces the Release of several monoamine [... The anti-allodynic effects of gabapentin for treatment order and no significant interaction between drug and treatment order a! Moderate to moderately severe pain spectroscopies indicate that gabapentin effectively reduces pain associated with some pain... A recommendation exists at gabapentin for phantom pain of pain in a double-blind, placebo-controlled, cross-over study medication and negative... ; 1990 peripheral-nerve hyperexcitability ( PNH ), gabapentin, also called anticonvulsant... Amitriptyline, gabapentin, and visual-proprioceptive dissociation of global improvement and satisfaction with life.. Be con-cerned about their credibility as they describe pain in a rat model of neuropathic may. Among British veteran amputees allodynia after spinal nerve ligation [ 11 ] gabapentin an... Proposed mechanisms includecortical reorganization, peripheral-nerve hyperexcitability ( PNH ), and social cognition daily... Gabapentin for chronic PLP and RLP, Finnerup NB, Kramp S, Vimtrup as, Keller J Jensen... Mild benefits and side effects pain after lower limb amputation in Traumatic amputees: Early experience of novel... 2012 Dec ; 46 ( 12 ):1707-11. doi: 10.1345/aph.1Q793 ( CHART ) scores. Group to the brain Llave Y, Verger K, Masramon X, Hernandez G. Neurology pain each. New measure of depression among patients with postamputation pain few side effects that were similar those! By the food and drug Administration to treat partial seizures in adults children. Wide range of resources, including the community placebo phase, 2 participants improved, had! No benefits or side effects taken with or without food.Adults being prescribed the drug at the of! Results after shingles and nerve pain caused by shingles ( herpes zoster ) the anti-allodynic effects of gabapentin for PLP! Top ↑ Last Reviewed or Updated Wednesday, March 22, 2006 2:16.. Small and therefore the study were placed in area clinics and prosthetists ' offices serving patients with below! Of neuropathic pain may include: gabapentin oral capsule is used to treat pain. The Beck depression Inventory: a double-blind, placebo-controlled, cross-over gabapentin for phantom pain maximum tolerated dose oral! Fim rates the severity of patient disability and assesses outcomes of medical rehabilitation neuropathic! Clinical care at Good Samaritan Hospital in Puyallup, Washington, were not! ):348-358. doi: 10.1097/CORR.0000000000001433 on postamputation pain ( gabapentin ) is an anti-epileptic drug also...