Huse 2001.
Methods |
Allocation: randomised. Control: placebo. Blinding: double‐blind. Arm: 2‐arm cross‐over. Centre: single. Setting and location: Pain Clinic, University Hospital, Tubingen, Germany. |
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Participants |
Inclusion criteria: leg amputees with phantom limb pain, pain intensity score ≥ 3/10 VAS, aged 18‐75 years. Exclusion criteria: neurological or psychiatric disorders, severe illness, pregnancy, breastfeeding, morphine‐specific sensitivities. Baseline characteristics n: 12. Gender: F 2, M 10. Age: mean 51 years (range 30‐71). Number randomised: 12. Number completed: 12. Baseline pain intensity: 4.7/10 (SD 1.1). |
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Interventions | Morphine: target 70‐300 mg. Placebo: oral glucose tablet. Duration: 2 × 4‐week treatment periods, preceded by 4‐week treatment‐free baseline period. Each treatment phase initiated by IV test infusion (same intervention as treatment phase + metoclopramide 5 mg), and treatments separated by 1‐ to 2‐week taper and washout. Starting dose of morphine not reported, possibly calculated from IV infusion. Titration allowed. 11 participants took 70‐160 mg daily; 1 took 300 mg daily. Additional analgesics: use of all analgesic and psychotropic medication was noted in the pain diary. |
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Outcomes |
Primary outcomes
At the end of each treatment period: Pain‐related Self‐assessment Scale and Self‐rating Depression Scale. Secondary outcomes
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Notes | Oxford Quality Score: R2, DB2, W1. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: states "randomized", but method used to generate random sequence not described. |
Allocation concealment (selection bias) | Low risk | Quote: "a physician who had no contact with the patients was responsible for the randomized distribution of the patients to the experimental conditions and kept the code." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Tablets were put into exactly identical pills by the pharmacy of the hospital." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: participant‐reported outcomes, participant blinded to intervention. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all followed up and 0 lost during treatment phase. |
Selective reporting (reporting bias) | Low risk | Comment: all planned outcomes in the methods were reported in the results. |
Size | High risk | Comment: 12 participants (n < 50). |