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Predicting long-term response to strong opioids in patients with low back pain: findings from a randomized, controlled trial of transdermal fentanyl and morphine.
BMC Med. 2007 Dec 21; 5:39.BM

Abstract

BACKGROUND

Some patients with long-standing low back pain will benefit from treatment with strong opioids. However, it would be helpful to predict which patients will have a good response. A fixed-term opioid trial has been recommended, but there is little evidence to suggest how long this trial should be. We assessed data from a large-scale randomized comparison of transdermal fentanyl (TDF) and sustained-release oral morphine (slow-release morphine; SRM) to determine characteristics of treatment responders.

METHODS

This was a secondary analysis of a previously published 13-month randomized trial involving 680 patients with long-standing low back pain (median age 52 years, 61% women, median duration of back pain 87 months). Pain relief was recorded using visual analogue scales (VAS). Treatment response was defined as pain relief of at least 30% from baseline to any point during the trial. We used a step-wise logistic regression to identify variables that might predict response to treatment. Covariates included treatment group, sex, age, duration of pain, presence of neuropathic pain, baseline pain scores, educational/employment status, use of high doses of opioids, and social functioning (SF)-36 scores.

RESULTS

Over half the patients in both groups (n = 370; 54% TDF, 55% SRM) were treatment responders. There were no differences between the TDF and SRM responders in terms of age, sex, type or duration of pain between responders and non-responders. The difference in response to treatment between responders and non-responders could be detected at 3 weeks. Lack of response after 1 month had a stronger negative predictive value (i.e., ability to detect non-responders) than the presence of response after 1 month. The most influential factors for predicting a response were employment status (chi2 = 11.06, p = 0.0259) and use of high doses of opioids (chi2 = 3.04, p = 0.0811).

CONCLUSION

No clear pattern of baseline pain (type or severity) or patient characteristics emerged that could be used to predict responders before the start of opioid treatment. However, a 1-month trial period appears sufficient to determine response and tolerability in most cases.

Authors+Show Affiliations

Pain Clinic, Helsinki University Central Hospital, Helsinki, Finland. eija.kalso@hus.fiNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

18154644

Citation

Kalso, Eija, et al. "Predicting Long-term Response to Strong Opioids in Patients With Low Back Pain: Findings From a Randomized, Controlled Trial of Transdermal Fentanyl and Morphine." BMC Medicine, vol. 5, 2007, p. 39.
Kalso E, Simpson KH, Slappendel R, et al. Predicting long-term response to strong opioids in patients with low back pain: findings from a randomized, controlled trial of transdermal fentanyl and morphine. BMC Med. 2007;5:39.
Kalso, E., Simpson, K. H., Slappendel, R., Dejonckheere, J., & Richarz, U. (2007). Predicting long-term response to strong opioids in patients with low back pain: findings from a randomized, controlled trial of transdermal fentanyl and morphine. BMC Medicine, 5, 39.
Kalso E, et al. Predicting Long-term Response to Strong Opioids in Patients With Low Back Pain: Findings From a Randomized, Controlled Trial of Transdermal Fentanyl and Morphine. BMC Med. 2007 Dec 21;5:39. PubMed PMID: 18154644.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Predicting long-term response to strong opioids in patients with low back pain: findings from a randomized, controlled trial of transdermal fentanyl and morphine. AU - Kalso,Eija, AU - Simpson,Karen H, AU - Slappendel,Robert, AU - Dejonckheere,Joachim, AU - Richarz,Ute, Y1 - 2007/12/21/ PY - 2007/03/29/received PY - 2007/12/21/accepted PY - 2007/12/25/pubmed PY - 2008/3/7/medline PY - 2007/12/25/entrez SP - 39 EP - 39 JF - BMC medicine JO - BMC Med VL - 5 N2 - BACKGROUND: Some patients with long-standing low back pain will benefit from treatment with strong opioids. However, it would be helpful to predict which patients will have a good response. A fixed-term opioid trial has been recommended, but there is little evidence to suggest how long this trial should be. We assessed data from a large-scale randomized comparison of transdermal fentanyl (TDF) and sustained-release oral morphine (slow-release morphine; SRM) to determine characteristics of treatment responders. METHODS: This was a secondary analysis of a previously published 13-month randomized trial involving 680 patients with long-standing low back pain (median age 52 years, 61% women, median duration of back pain 87 months). Pain relief was recorded using visual analogue scales (VAS). Treatment response was defined as pain relief of at least 30% from baseline to any point during the trial. We used a step-wise logistic regression to identify variables that might predict response to treatment. Covariates included treatment group, sex, age, duration of pain, presence of neuropathic pain, baseline pain scores, educational/employment status, use of high doses of opioids, and social functioning (SF)-36 scores. RESULTS: Over half the patients in both groups (n = 370; 54% TDF, 55% SRM) were treatment responders. There were no differences between the TDF and SRM responders in terms of age, sex, type or duration of pain between responders and non-responders. The difference in response to treatment between responders and non-responders could be detected at 3 weeks. Lack of response after 1 month had a stronger negative predictive value (i.e., ability to detect non-responders) than the presence of response after 1 month. The most influential factors for predicting a response were employment status (chi2 = 11.06, p = 0.0259) and use of high doses of opioids (chi2 = 3.04, p = 0.0811). CONCLUSION: No clear pattern of baseline pain (type or severity) or patient characteristics emerged that could be used to predict responders before the start of opioid treatment. However, a 1-month trial period appears sufficient to determine response and tolerability in most cases. SN - 1741-7015 UR - https://www.unboundmedicine.com/medline/citation/18154644/Predicting_long_term_response_to_strong_opioids_in_patients_with_low_back_pain:_findings_from_a_randomized_controlled_trial_of_transdermal_fentanyl_and_morphine_ L2 - https://bmcmedicine.biomedcentral.com/articles/10.1186/1741-7015-5-39 DB - PRIME DP - Unbound Medicine ER -