Table 5.
Other outcomes: summary of measures and results
First author (year) | Purpose and intervention | Outcome measures | Main findings |
---|---|---|---|
Nathan et al. (2017)[63] |
Purpose: Evaluate the effectiveness of community-based mindfulness-based stress reduction (MBSR) courses to improve physical and mental functioning among patients with PDPN whose medical treatment has been optimized. Intervention: Nine sessions of MBSR: eight weekly, 2.5-h sessions and one 6-h session on a weekend day midway through the course. Control: Usual activities, offered the opportunity to enroll in a MBSR course once the study was complete. |
Glycosylated hemoglobin (HbA1c) measurement; Patient Health Questionnaire-9 (PHQ-9) for depression; Profile of Mood States-2A (POMS-2A) for total mood disturbance; Perceived Stress Scale (PSS); Pain Catastrophizing Scale (PCS) | Mean PCS score decreased in the MBSR group (− 10.67, 95% CIs [− 14.38 to − 6.95]), between baseline and week 12, compared to the control group (1.69, 95% CIs [− 1.47 to 4.85], p < 0.001). Mean PHQ-9 score significantly reduced in the MBSR group (M = − 4.75, 95% CIs [− 6.55 to − 2.96], p < 0.001), between baseline and week 12, compared to the control group (M = 0.06, 95% CIs [− 1.66 to 1.53], p < 0.001). The MBSR group mean PSS reduced between baseline and week 12 (M = − 4.64, 95% CIs [− 7.89 to − 1.38], p = 0.001), compared to the control group (M = 1.75, 95% CIs [− 0.14 to 3.64], p = 0.001). |
Clark et al. (2012)[60] |
Purpose: Determine the feasibility of using 3 complementary interventions in relieving the physical and emotional symptoms associated with CIPN while increasing the capacity for mindfulness or self-focused attention. Intervention: D. Reiki intervention (n = 7)—up to 5 sessions over a 6-week period E. Yoga intervention (n = 7)—weekly session over 6 weeks F. Meditation intervention (n = 5)—weekly session over 6 weeks Control: 1 h holistic education weekly for 6 weeks |
Psychological distress using the Brief Symptom Inventory (BSI); Mindfulness using the Mindful Awareness Attention Scale (MAAS). | No significant difference between groups on BSI and MAAS |
Ahn and Song (2012)[67] |
Purpose: Determine the effects of tai chi exercise on glucose control, neuropathy scores, balance, and quality of life in patients with diabetic PN. Intervention: Standardized tai chi for diabetes of 1 h of tai chi per session, twice a week for 12 weeks. Control: Usual care |
Fasting blood sugar (FBS); HbA1c; Semmes–Weinstein 10-g monofilament examination scores (SWME); single leg stance for balance. | Mean FBS reduced in the intervention group (M = 137.85 mg/dL, SD = 45.19 to 125.5 mg/dL, SD = 45.57, p = 0.036) compared to the control group (M = 143.47 mg/dL, SD = 47.45 to 155.31 mg/dL, SD = 44.88, p = 0.036). A significant difference was seen in HbA1c levels post-intervention in the tai chi group (M = 7.20, SD = 1.32, p = 0.004) compared to the control group (M = 8.32, SD = 1.76, p = 0.004). Differences in pre- and post-test balance mean scores indicated significant improvement in balance for the tai chi group (M = − 7.65, SD = 16.78, p = 0.044), compared to the control group (M = 1.44, SD = 9.97, p = 0.044). The SWME identified no significant changes in peripheral sensory function pre- and post-test. |
Kluding et al. (2012)[64] |
Purpose: Examine the feasibility of a supervised, moderately intense aerobic and resistance exercise program in people with diagnosed diabetic PN. Intervention: 10-week exercise program with both aerobic and strengthening elements, 3 to 4 times per week. Control: None |
BMI; Resting heart rate (RHR) Glycosylated hemoglobin (HbA1c); Michigan Neuropathy Screening Instrument (MNSI) physical exam score; Nerve conduction studies (NCS); Quantitative Sensory Testing (QST); intraepidermal nerve fiber density (IENF) |
Significant reduction in HbA1c (M = 7.8, SD = 1.0 pre-intervention to M = 7.28, SD = 0.83 post-intervention, p = 0.031). Significant increase in IENF branching at the proximal biopsy site (M = 0.16, SD = 0.15 pre-intervention to M = 0.27, SD = 0.19 post-intervention, p = 0.008). Significant reduction in RHR (M = 77.3, SD = 8.2 pre-intervention to M = 72, SD = 9.6 post-intervention, p = 0.036). No significant difference in NCS or QST |
Ruhland and Shields (1997)[65] |
Purpose: Examine the effects of a home exercise program on PN impairment and quality of life. Intervention: Exercise with Thera-Bands and cycling or walking for 10 to 20 min, over 6 weeks. Control: Maintain current levels of activity |
Average Muscle Score (AMS); handgrip force; forced vital capacity (FVC); timed 9.1 m walk | Significant improvement in mean AMS in exercise group (pre-test M = 8.8, post-test M = 9.2, p = 0.002); significant improvement in handgrip force (pre-test M = 28.6, post-test M = 30.8, p = 0.033) |
Yoo et al. (2015)[61] |
Purpose: Explore the effect of a supervised, moderate-intensity aerobic exercise training intervention on pain and pain interference in daily life, specifically in people with DPN. Intervention: 16 weeks of supervised aerobic exercise 3 times a week, of 30 to 50 min duration. Control: None |
Objective: body mass index (BMI); aerobic fitness (VO2max); blood pressure; glycemic control (hemoglobin A1c) | No significant changes were found for BMI, blood pressure, or glycemic control. Significant improvement in mean maximum oxygen uptake (VO2max) (mL/kg/min) (M = 16.02, SD = 3.84 pre to M = 17.18, SD = 4.19 post, p = 0.028). |
Gewandter et al. (2018)[72] |
Purpose: To inform a future randomized phase 2 study and determine if TENS has the potential to improve CIPN. Intervention: Wireless TENS therapy for at least 1 h twice per day for a 6-week period. Control: None |
Objective: Utah Early Neuropathy Score (UENS); forced choice monofilament test | No significant improvements with UENS; monofilament test reported sensation threshold improved in 10 of 16 (63%; 95% CI [35–85%], p < 0.0001) participants who completed the test. |
Serry et al. (2015)[71] |
Purpose: To investigate the efficacy of TENS versus aerobic exercise, and to compare them with regular pharmacological therapy in patients with diabetic PN. Group A: Received TENS therapy for 30 min 3 times per week for 8 weeks in addition to regular pharmacological therapy for PN. Group B: Engaged in aerobic exercise for 30 min 3 times for week for 8 weeks in addition to regular pharmacological therapy for PN. Group C: Received only regular pharmacological therapy for PN and oral hypoglycemic drugs or insulin. |
Nerve conduction studies (NCS) to measure medial plantar sensory nerve conduction velocity (SCV) | No significant differences in SCV between pre- and post-test measurements for any of the groups, or between the groups |
McCrary et al. (2019)[68] |
Purpose: Evaluate the impact of a multimodal exercise intervention on CIPN symptoms, functional deficits and neurophysiologic parameters. Intervention: 8-week exercise intervention with resistance, balance, and cardio elements, 3 times per week. Control: 8 week pre-intervention control period |
Objective: Total Neuropathy Score Clinical version (TNSc); mobility (6 min timed walk); standing balance (Swaymeter); lower limb strength and dynamic balance (5 times sit to stand test) | Significant reduction in TNSc symptom score (M = 7.0, SE = 0.7 pre-exercise to M = 5.3, SE = 0.5 post-exercise, p = 0.001); significant increase in distance in 6 min walk test (m) (M = 452.1, SE = 17.4 pre-exercise to M = 469.9, SE = 20.9 post-exercise, p = 0.02); significant reduction in 5 times sit to stand time (s) (M = 13.1, SE = 0.8 pre-exercise to M = 11.8, SE = 0.6 post-exercise, p = 0.03); significant reduction in postural sway (mm) on a stable surface eyes open (M = 140.9, SE = 23.6 pre-exercise to M = 104.2, SE = 13.6 post-exercise, p = 0.006) |
PDPN = painful diabetic peripheral neuropathy; CI = confidence interval; M = mean; mg = milligram; dL = deciliter; SD = standard deviation; PN = peripheral neuropathy; kg = kilogram; min = minute; DPN = diabetic peripheral neuropathy; TENS = transcutaneous electrical nervous stimulation; CIPN = chemotherapy-induced peripheral neuropathy; SE = standard error