Limits...
Investigating the role of neuropathic pain relief in decreasing gait variability in diabetes mellitus patients with neuropathic pain: a randomized, double-blind crossover trial.

Karmakar S, Rashidian H, Chan C, Liu C, Toth C - J Neuroeng Rehabil (2014)

Bottom Line: Our hypothesis was that PDPN subjects would have decreased gait step variability when receiving pharmacological relief of NeP.PDPN subjects developed increased, rather than decreased, step length and step velocity variability during pregabalin treatment.Non-significant NeP relief occurred in the pregabalin phase of study as compared with placebo.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Neurosciences, HMRB 155, Foothills Hospital, University of Calgary, Hotchkiss Brain Institute, 3330 Hospital Dr, NW, Calgary T2N 4 N1, AB, Canada. corytoth@shaw.ca.

ABSTRACT

Background: Subjects with diabetes mellitus (DM) develop gait dysfunction contributing to falls, reluctance to perform activities and injuries. Neuropathic pain (NeP) related to diabetic peripheral neuropathy (DPN) is associated with increased gait variability that may contribute to gait dysfunction. We used a portable device (GaitMeter™) and related gait and balance measures to measure gait parameters in painful DPN (PDPN) subjects prior to and during analgesia. Our hypothesis was that PDPN subjects would have decreased gait step variability when receiving pharmacological relief of NeP.

Methods: DPN subjects with at least moderate NeP were assessed in a randomized, double-blind crossover study of pregabalin versus placebo. The outcome measure was variability in step length and step velocity. Testing for Timed Get-Up-and-Go Test, Tinetti Mobility Scales, Sway Testing, a Physiological Profile Approach, and fall-related surveys were also performed. DPN severity was quantified using the Utah Early Neuropathy Score.

Results: PDPN subjects developed increased, rather than decreased, step length and step velocity variability during pregabalin treatment. There were no significant differences between cohorts for other physiological gait and balance testing. Non-significant NeP relief occurred in the pregabalin phase of study as compared with placebo. There was a negative relationship for step length with pain severity.

Conclusion: Analgesia did not decrease gait variability in PDPN patients, and in fact, increased gait variability was seen during pregabalin treatment. Other important relationships of gait dysfunction with PDPN should be sought.

Show MeSH

Related in: MedlinePlus

A flowchart of subjects throughout the study using the CONSORT guidelines.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
getmorefigures.php?uid=PMC4150964&req=5

Fig1: A flowchart of subjects throughout the study using the CONSORT guidelines.

Mentions: A randomization table assigned subjects to the first cross-over intervention phase. Randomization concealment occurred for subjects, the clinical coordinator, and the study physician. Scheduled study portions were as follows: 1) Pre-screening to allow wash-out of any prohibited medications (see below); 2) a one week screening period to ensure subject eligibility into the study; 3) a six week randomized active treatment period (Intervention 1); 4) a two week washout period with weaning of pregabalin/placebo; 5) a six week randomized active treatment period (Intervention 2); and 6) a one week follow-up period with weaning of placebo/pregabalin (Figure 1). Telephone visits took place one week into each intervention period, and one week after the washout period to assess tolerability and adverse effects.Figure 1


Investigating the role of neuropathic pain relief in decreasing gait variability in diabetes mellitus patients with neuropathic pain: a randomized, double-blind crossover trial.

Karmakar S, Rashidian H, Chan C, Liu C, Toth C - J Neuroeng Rehabil (2014)

A flowchart of subjects throughout the study using the CONSORT guidelines.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4150964&req=5

Fig1: A flowchart of subjects throughout the study using the CONSORT guidelines.
Mentions: A randomization table assigned subjects to the first cross-over intervention phase. Randomization concealment occurred for subjects, the clinical coordinator, and the study physician. Scheduled study portions were as follows: 1) Pre-screening to allow wash-out of any prohibited medications (see below); 2) a one week screening period to ensure subject eligibility into the study; 3) a six week randomized active treatment period (Intervention 1); 4) a two week washout period with weaning of pregabalin/placebo; 5) a six week randomized active treatment period (Intervention 2); and 6) a one week follow-up period with weaning of placebo/pregabalin (Figure 1). Telephone visits took place one week into each intervention period, and one week after the washout period to assess tolerability and adverse effects.Figure 1

Bottom Line: Our hypothesis was that PDPN subjects would have decreased gait step variability when receiving pharmacological relief of NeP.PDPN subjects developed increased, rather than decreased, step length and step velocity variability during pregabalin treatment.Non-significant NeP relief occurred in the pregabalin phase of study as compared with placebo.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Neurosciences, HMRB 155, Foothills Hospital, University of Calgary, Hotchkiss Brain Institute, 3330 Hospital Dr, NW, Calgary T2N 4 N1, AB, Canada. corytoth@shaw.ca.

ABSTRACT

Background: Subjects with diabetes mellitus (DM) develop gait dysfunction contributing to falls, reluctance to perform activities and injuries. Neuropathic pain (NeP) related to diabetic peripheral neuropathy (DPN) is associated with increased gait variability that may contribute to gait dysfunction. We used a portable device (GaitMeter™) and related gait and balance measures to measure gait parameters in painful DPN (PDPN) subjects prior to and during analgesia. Our hypothesis was that PDPN subjects would have decreased gait step variability when receiving pharmacological relief of NeP.

Methods: DPN subjects with at least moderate NeP were assessed in a randomized, double-blind crossover study of pregabalin versus placebo. The outcome measure was variability in step length and step velocity. Testing for Timed Get-Up-and-Go Test, Tinetti Mobility Scales, Sway Testing, a Physiological Profile Approach, and fall-related surveys were also performed. DPN severity was quantified using the Utah Early Neuropathy Score.

Results: PDPN subjects developed increased, rather than decreased, step length and step velocity variability during pregabalin treatment. There were no significant differences between cohorts for other physiological gait and balance testing. Non-significant NeP relief occurred in the pregabalin phase of study as compared with placebo. There was a negative relationship for step length with pain severity.

Conclusion: Analgesia did not decrease gait variability in PDPN patients, and in fact, increased gait variability was seen during pregabalin treatment. Other important relationships of gait dysfunction with PDPN should be sought.

Show MeSH
Related in: MedlinePlus