Mindful Walking in Patients with Chronic Low Back Pain: A Randomized Controlled Trial.

Aim: The objective of this study was to investigate the effectiveness of a mindful walking program (MWP) in patients with chronic low back pain (CLBP). Methods: The trial was a two-armed, randomized, controlled single-center open clinical trial. The study was performed in the Outpatient Clinic for Integrative Medicine of the Charité-Universitätsmedizin Berlin. The participants were adults aged 18-65 years with CLBP (≥3 months) and an average low back pain within the past 7 days measured on a visual analog scale (VAS, 0 = no pain, 100 = worst imaginable pain) of at least 40 mm. The patients received either eight weekly MWP sessions or no intervention (control). The primary outcome was the perceived pain intensity assessed with a VAS (0-100 mm) after 8 weeks. The secondary outcomes included back function assessed by the Hannover Functional Questionnaire Backache (FFbH-R) and perceived stress assessed by the 14-item Cohen's Perceived Stress Scale (PSS-14). The results were obtained by analysis of covariance adjusted for the respective baseline values. Results: In total, 55 patients were randomized (MWP: n = 29, 82.8% female, mean (±standard deviation) age: 52.5 ± 8.6 years, pain: 56.4 ± 14.1 mm; control: n = 26, 84.6% female, 54.8 ± 7.5 years, pain: 55.4 ± 13.1 mm). After 8 weeks, compared with the control conditions, the MWP was not associated with a statistically significant benefit for pain (VAS), adjusted mean - 9.6 [-22.3 to 3.1], p = 0.136, clinical benefits for back function (FFbH-R), adjusted mean 2.2 [-4.2 to 8.6], p = 0.493, or stress (PSS-14), adjusted mean - 1.6 [-4.8 to 1.6], p = 0.326. Conclusion: In conclusion, compared with no intervention, mindful walking did not significantly improve pain, back function, or perceived stress in patients with CLBP. Clinical Trial registration: ClinicalTrials.gov (NCT01893073).

Effects and feasibility of an Integrative Medicine program for geriatric patients-a cluster-randomized pilot study.

BACKGROUND: Older adults often use complementary medicine; however, very few interventional studies have focused on them. The aim of this study was to evaluate the feasibility and to obtain preliminary data on effectiveness of an Integrative Medicine (IM) program compared to usual medical care. METHODS: The study consisted of older adults living in shared apartment communities including caregiving. The shared apartments were cluster-randomized to the IM program or Usual Care (UC). IM consisted of additional lifestyle modification (exercise and diet), external naturopathic applications, homeopathic treatment, and modification of conventional drug therapy for 12 months. The UC group received conventional care alone. The following outcomes were used: Nurses Observation Scale for Geriatric Patients (NOSGER); Assessment of Motor and Process Skills; Barthel Index; Qualidem; Profile of Wellbeing; and Mini-mental State Examination. Exploratory effect sizes (Cohen's d, means adjusted for differences of baseline values) were calculated to analyze group differences. RESULTS: A total of eight shared apartment communities were included; four were allocated to IM (29 patients, median seven patients; [mean ± standard deviation] 82.7 ± 8.6 years) and four to UC (29 patients, median eight patients; 76.0 ± 12.8 years of age). After 12 months, effect sizes ≥0.3 were observed for activities of daily living on the NOSGER-Activities of Daily Living subscale (0.53), Barthel Index (0.30), Qualidem total sum score (0.39), Profile of Wellbeing (0.36), NOSGER-Impaired Social Behavior (0.47), and NOSGER-Depressed Mood subscales (0.40). Smaller or no effects were observed for all other outcomes. The intervention itself was found to be feasible, but elaborate and time consuming. DISCUSSION: This exploratory pilot study showed that for a full-scale trial, the outcomes of Activities of Daily Living and Quality of Life seem to be the most promising. The results have to be interpreted with care; larger confirmatory trials are necessary to validate the effects.