Abstract
Context: Chronic pain is often present in patients with diabetes mellitus.
Objective: To assess the effects of osteopathic manual treatment (OMT) in patients with diabetes mellitus and comorbid chronic low back pain (LBP).
Design: Randomized, double-blind, sham-controlled, 2×2 factorial trial, including OMT and ultrasound therapy (UST) interventions.
Setting: University-based study in Dallas-Fort Worth, Texas.
Patients: A subgroup of 34 patients (7%) with diabetes mellitus within 455 adult patients with nonspecific chronic LBP enrolled in the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial.
Main Study Measures: The Outpatient Osteopathic SOAP Note Form was used to measure somatic dysfunction at baseline. A 100-mm visual analog scale was used to measure LBP severity over 12 weeks from randomization to study exit. Paired serum concentrations of tumor-necrosis factor (TNF)-α obtained at baseline and study exit were available for 6 subgroup patients.
Results: Key osteopathic lesions were observed in 27 patients (79%) with diabetes mellitus vs 243 patients (58%) without diabetes mellitus (P=.01). The reduction in LBP severity over 12 weeks was significantly greater in 19 patients with diabetes mellitus who received OMT than in 15 patients with diabetes mellitus who received sham OMT (mean between-group difference in changes in the visual analog scale pain score, −17 mm; 95% confidence interval [CI], −32 mm to −1 mm; P=.04). This difference was clinically relevant (Cohen d=0.7). A corresponding significantly greater reduction in TNF-α serum concentration was noted in patients with diabetes mellitus who received OMT, compared with those who received sham OMT (mean between-group difference, −6.6 pg/mL; 95% CI, −12.4 to −0.8 pg/mL; P=.03). This reduction was also clinically relevant (Cohen d=2.7). No significant changes in LBP severity or TNF-α serum concentration were associated with UST during the 12-week period.
Conclusion: Severe somatic dysfunction was present significantly more often in patients with diabetes mellitus than in patients without diabetes mellitus. Patients with diabetes mellitus who received OMT had significant reductions in LBP severity during the 12-week period. Decreased circulating levels of TNF-α may represent a possible mechanism for OMT effects in patients with diabetes mellitus. A larger clinical trial of patients with diabetes mellitus and comorbid chronic LBP is warranted to more definitively assess the efficacy and mechanisms of action of OMT in this population.
Diabetes mellitus affects approximately 26 million persons (8%) in the United States, including an estimated 7 million persons in whom the disease is undiagnosed.
1 Type 2 diabetes mellitus (T2DM) comprises up to 95% of US adults with diagnosed diabetes mellitus.
1 Moreover, the prevalence of T2DM in children and adolescents is increasing as a consequence of the continuing rise in obesity in this population.
2 Early identification and treatment may help control diabetes mellitus and prevent or delay such associated consequences as blindness, kidney damage, and lower-limb amputations. Such interventions may also help contain the costs of diabetes mellitus, which were estimated to be $174 billion in the United States, including both medical expenditures and costs associated with lost productivity.
1
Osteopathic philosophy is based on 4 key principles
3: (1) the body is a unit; (2) the body possesses self-regulatory mechanisms; (3) structure and function are reciprocally interrelated; and (4) rational therapy is based on an understanding of body unity, self-regulatory mechanisms, and the interrelationship of structure and function. Osteopathic manual treatment (OMT) may be used to alleviate somatic dysfunction, which is defined as impaired or altered function of related components of the somatic (body framework) system: skeletal, arthrodial, and myofascial structures, and related vascular, lymphatic, and neural elements.
4 Osteopathic philosophy also maintains that visceral disorders may have somatic manifestations caused by underlying disease processes. Such somatic manifestations of visceral disorders have been termed viscerosomatic reflexes (VSRs) and are identified by osteopathic palpatory examination for TART criteria (ie, tissue texture abnormalities, asymmetry of landmarks, restriction of motion, and tenderness) or Chapman reflex points.
5 In addition, osteopathic philosophy maintains that OMT of VSRs may have a specific impact on the underlying disease processes via reciprocal somatovisceral reflexes.
The scant osteopathic literature on diabetes mellitus appears to support both the existence of pancreatic VSRs in individuals with type 1 diabetes mellitus and the purported benefits of OMT specifically targeted at such VSRs. Bandeen
6 reported crude data on the temporal relationship between pancreatic stimulatory and inhibitory OMT techniques and alterations in blood glucose levels in patients with and without diabetes mellitus. A contemporary reanalysis of these data revealed that pancreatic stimulatory techniques decreased blood glucose levels within 30 to 60 minutes, whereas pancreatic inhibitory techniques increased blood glucose levels within this time frame.
7 More recently, it was hypothesized that tissue texture abnormalities at the level of the thoracic (T) 11 through lumbar (L) 2 spinal segments are VSRs indicative of nephropathy in patients with T2DM.
8 The augmented VSR responses observed in patients with T2DM of longer duration and comorbid hypertension strengthened the argument for causality between underlying renal pathology and palpated tissue texture abnormalities at the T11-L2 spinal segmental levels.
8
Patients with T2DM often have other comorbid conditions, such as obesity, that may predispose them to developing somatic dysfunction and chronic pain that is not caused by T2DM-specific disease processes. Chronic daily pain is highly prevalent in patients with diabetes mellitus.
9 Chronic pain also adversely impacts aspects of diabetes mellitus self-management, including diet, exercise, and medication adherence.
10 The tenets of osteopathic medicine lend themselves to a proactive approach to the treatment of patients with diabetes mellitus.
11 The purpose of the present study was to use data from the OSTEOPAThic Health outcomes In Chronic low back pain (OSTEOPATHIC) Trial to further explore the potential benefits of OMT and ultrasound therapy (UST) in the management of chronic low back pain (LBP) in patients with diabetes mellitus.