PHANTOM PAIN MANAGEMENT CLINICAL TRIALS TRIAL
Four trials examined late postoperative interventions, including transcutaneous electrical nerve stimulation (two trials) and the use of Farabloc (a metal threaded sock) and ketamine (one trial each). Three trials demonstrated a positive impact of the intervention on phantom limb pain, but the remainder demonstrated no difference between the intervention and control groups. Eight trials examined treatment of acute phantom pain, including epidural treatments (three trials), regional nerve blocks (three trials), treatment with calcitonin (one trial), and transcutaneous electrical nerve stimulation (one trial). Only three randomized, controlled studies with parallel groups and three randomized crossover trials were identified.
Twelve trials were identified, including 375 patients whose follow-ups ranged in duration from 1 week to 2 years. Included trials involved a control group, any intervention, and reported phantom pain as an outcome. Trials were identified by a systematic search of MEDLINE, review articles, and references of relevant trials from the period 1966-1999, including only English-language articles. For both study phases the treatment effects will be compared between the strata and also inside each stratum, using each patient as his own control.The objective was to examine the evidence to determine the optimal management of phantom limb pain in the preoperative and postoperative phase of amputations. The study closes at the end of the second treatment period. The main outcome indicators will be gathered at the start and the end of the second treatment period. The duration of the second treatment period will be maximum three weeks, but each patient may decide to interrupt the treatment at an earlier stage if he finds the effect satisfactory. When symptoms of phantom limb pain and/or CRPS resume, the patients will undergo a second treatment period with the same treatment as during phase one. Phase two: The responders will be observed for a period of maximum three months. The M+T non-responders discontinue the study. Non-responders (NR) will be allocated for an immediate second three-weeks treatment period of combined treatment (M+T) the responders (R) of the M, T and M+T enter the second phase of the study. The main outcome variables will be gathered before the initial randomization and after an initial treatment period of three weeks. Phase one: The study patients will be randomized for M or T treatment. The second phase includes the responders from the initial treatment (M or T), the duration of the initial treatment effect will be observed, and the effect of a second round of similar treatment will be registered. The study will be conducted in two phases: Firstly, the effects of mirror treatment (M) versus tactile treatment (T) will be compared in an open, randomized, semi-cross-over case-control design study. Why Should I Register and Submit Results?.