Report of the National Institutes of Health task force on research standards for chronic low back pain.

OBJECTIVES: Despite rapidly increasing intervention, functional disability due to chronic low back pain (cLBP) has increased in recent decades. We often cannot identify mechanisms to explain the major negative impact cLBP has on patients' lives. Such cLBP is often termed nonspecific and may be due to multiple biologic and behavioral etiologies. Researchers use varied inclusion criteria, definitions, baseline assessments, and outcome measures, which impede comparisons and consensus. The purpose of this article is to disseminate the report of the National Institutes of Health (NIH) task force on research standards for cLBP. METHODS: The NIH Pain Consortium charged a research task force (RTF) to draft standards for research on cLBP. The resulting multidisciplinary panel developed a 3-stage process, each with a 2-day meeting. RESULTS: The panel recommended using 2 questions to define cLBP; classifying cLBP by its impact (defined by pain intensity, pain interference, and physical function); use of a minimal data set to describe research subjects (drawing heavily on the Patient Reported Outcomes Measurement Information System methodology); reporting "responder analyses" in addition to mean outcome scores; and suggestions for future research and dissemination. The Pain Consortium has approved these recommendations, which investigators should incorporate into NIH grant proposals. CONCLUSIONS: The RTF believes that these recommendations will advance the field, help to resolve controversies, and facilitate future research addressing the genomic, neurologic, and other mechanistic substrates of cLBP. Greater consistency in reporting should facilitate comparisons among studies and the development of phenotypes. We expect the RTF recommendations will become a dynamic document and undergo continual improvement.

Comparative effectiveness of traditional Chinese medicine and psychosocial care in the treatment of temporomandibular disorders-associated chronic facial pain.

UNLABELLED: This dual-site study sought to identify the appropriate role for traditional Chinese medicine (TCM; acupuncture and herbs) in conjunction with a validated psychosocial self-care (SC) intervention for treating chronic temporomandibular disorders (TMD)-associated pain. Participants with Research Diagnostic Criteria for Temporomandibular Disorders-confirmed TMD (n = 168) entered a stepped-care protocol that began with a basic TMD class. At weeks 2 and 10, patients receiving SC whose worst facial pain was above predetermined levels were reallocated by minimization to SC or TCM with experienced practitioners. Characteristic facial pain (CFP: mean of worst pain, average pain when having pain, and current pain; each visual analog scale [VAS] 0-10) was the primary outcome. Social activity interference (VAS 0-10) was a secondary outcome. Patients were monitored for safety. TCM provided significantly greater short-term (8-week) relief than SC (CFP reduction difference, -.60 [standard deviation of the estimate .26], P = .020) and greater reduction in interference with social activities (-.81 [standard deviation of the estimate .33], P = .016). In 2 of 5 treatment trajectory groups, more than two thirds of participants demonstrated clinically meaningful responses (≥30% improvement) in pain interference over 16 weeks. This study provides evidence that TMD patients referred for TCM in a community-based model will receive safe treatment that is likely to provide some short-term pain relief and improved quality of life. Similar designs may also apply to evaluations of other kinds of chronic pain. (ClinicalTrials.gov number NCT00856167). PERSPECTIVE: This short-term comparative effectiveness study of chronic facial pain suggests that TCM is safe and frequently efficacious alone or subsequent to standard psychosocial interventions. TCM is widely available throughout North America and may provide clinicians and patients with a reasonable addition or alternative to other forms of therapy.

Reductions in pain medication use associated with traditional Chinese medicine for chronic pain.

CONTEXT: Participants in a randomized trial of traditional Chinese medicine (TCM) for temporomandibular joint dysfunction (TMD) had a linear decline in pain over 16 TCM visits. OBJECTIVE: To investigate whether reductions in pain among participants receiving TCM can be explained by increased use of pain medications, or whether use of pain medications also declined in this group. DESIGN: One hundred sixty-eight participants with TMD were treated with TCM or enhanced self-care according to a stepped-care design. Those for whom self-care failed were sequentially randomized to further self-care or TCM. This report includes 111 participants during their first 16 TCM visits. The initial 8 visits occurred more than once a week; participants and practitioners determined the frequency of subsequent visits. OUTCOME MEASURES: Average pain (visual analog scale, range 0-10) and morphine and aspirin dose equivalents. RESULTS: The sample was 87% women and the average age was 44 ± 13 years. Average pain of narcotics users (n = 21) improved by 2.73 units over 16 visits (p < 0.001). Overall narcotics use trended downward until visit 11 (-3.27 doses/week, p = 0.156), and then trended upward until week 16 (+4.29 doses/week, p = 0.264). Among those using narcotics, use of nonsteroidal anti-inflammatory drugs (NSAIDs) declined linearly over visits 1-16 (-1.94 doses/week, p = 0.002).Among the top quartile of NSAID-only users (n = 22), average pain decreased linearly over 16 visits (-1.52 units, p = 0.036). Overall NSAID doses/week declined between visits 1 and 7 (-9.95 doses/week, p < 0.001) and then remained stable through 16 visits. NSAID use also declined among the third quartile (n = 23) and remained low and stable among the lower half (sorted by total intake) of NSAID users. CONCLUSIONS: Among the heaviest NSAID users, we observed a short-term reduction in NSAID use that was sustained as TCM visits became less frequent. There was no indication that pain reduction during TCM treatment was influenced by drug use.

A pilot whole systems clinical trial of traditional Chinese medicine and naturopathic medicine for the treatment of temporomandibular disorders.

OBJECTIVES: To assess the feasibility and acceptability of studying whole systems of Traditional Chinese Medicine (TCM) and Naturopathic medicine (NM) in the treatment of temporomandibular disorders (TMD), and to determine whether there is indication to support further research. DESIGN: A pilot study using a randomized controlled clinical trial design of whole system TCM and NM versus state-of-the-art specialty care (SC). SETTING/LOCATION: Kaiser Permanente Northwest (KPNW), and practitioner offices in Portland, Oregon. SUBJECTS: One hundred and sixty (160) women 25-55 years of age attending a KPNW TMD specialty clinic. INTERVENTIONS: Whole system TCM and NM, and KPNW TMD clinic SC; the intervention protocols were designed to model the individually tailored type of community care offered in alternative medicine practices in Portland and in the KPNW TMD clinic, using protocols that enhanced similarities among practitioners within each system and permitted full descriptions of the treatments provided. OUTCOME MEASURES: TMD was ascertained using the Research Diagnostic Criteria/TMD; outcomes were self-reported worst and average facial pain and interference with activities (scaled 0-10 where 10 is worst). RESULTS: Of 948 consecutive eligible patients, 160 were randomized to one of three arms; 128 provided endpoint data. TCM and NM demonstrated significantly greater in-treatment reductions for worst facial pain compared to SC (adjusted regression analysis; higher negative values indicate greater improvement, = -1.11 +/- 0.43, p = 0.010 and -1.02 +/- 0.45, p = 0.025 for TCM and NM, respectively, compared to SC) and at 3 months post-treatment (-1.07 +/- 0.51, p = 0.037 and -1.27 +/- 0.54, p = 0.019 for TCM and NM versus SC, respectively). Additionally, TCM provided significantly greater decreases in average pain than SC; NM provided significantly greater decreases than SC or TCM in TMD-related psychosocial interference. CONCLUSIONS: These alternative medicine approaches each resulted in significantly greater reduction of pain and psychosocial interference than SC. Further research on the potential benefits of traditional whole systems of medicine for TMD appears warranted.

The efficacy of traditional, low-cost and nonsplint therapies for temporomandibular disorder: a randomized controlled trial.

BACKGROUND: Treatment recommendations for patients with painful temporomandibular disorders (TMDs) range from conservative treatments such as physiotherapy to aggressive and irreversible treatments such as restorative reconstruction and joint surgery. METHODS: The authors randomized 200 subjects diagnosed with TMD into three groups: usual conservative, dentist-prescribed self-care treatment without any intraoral splint appliance (UT); UT plus a conventional flat-plane hard acrylic splint (HS); and UT plus a soft vinyl (a low-cost athletic mouth guard) splint (SS). Subjects completed questionnaires and clinical examinations at three, six and 12 months. RESULTS: The authors observed no significant differences among the groups in TMD-related pain levels or other common signs and symptoms of TMD at baseline (BL) or at any follow-up. The changes from BL were comparable for all three groups. The authors did not note any significant differences at any follow-up for compliance with study protocols or for occurrences of adverse effects from either splint type. For HS versus SS, there were significant differences in rates of splint use, but these differences were not accompanied by differences in either self-reported symptoms or in clinical findings. CONCLUSIONS: All patients improved over time, and traditional splint therapy offered no benefit over the SS splint therapy. Neither splint therapy provided a greater benefit than did self-care treatment without splint therapy. CLINICAL IMPLICATIONS: These findings suggest that clinicians who treat patients with TMD should consider prescribing low-cost nonsplint self-care therapy for most patients.

A randomized clinical trial of a tailored comprehensive care treatment program for temporomandibular disorders.

AIMS: To test the usefulness of tailoring cognitive-behavioral therapy (CBT) for patients with temporomandibular disorders (TMD) who demonstrated poor psychosocial adaptation to their TMD condition, independent of physical diagnosis. METHODS: A randomized clinical trial compared a 6-session CBT intervention delivered in conjunction with the usual TMD treatment to the usual conservative treatment by TMD specialist dentists. For study inclusion, Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), Axis II criteria, were used to target patients with elevated levels of TMD pain-related interference with daily activities, independent of physical diagnosis (i.e., Axis I). RESULTS: At the post-treatment assessment, about 4 months after the baseline evaluations, the comprehensive care group, when compared to the usual treatment group, showed significantly lower levels of characteristic pain intensity, significantly higher self-reported ability to control their TMD pain, and a strong trend (P = .07) toward lower pain-related interference in daily activities. From post-intervention to 1-year follow-up, all subjects showed improvement. At the 1-year follow-up, the comprehensive care group, while not losing any of its early gains, was not significantly different from the usual care group with regard to reported levels of pain, ability to control pain, and levels of interference in activities. For many of these psychosocially disabled TMD patients, pain and interference 1 year after treatment remained at the same or higher levels than those observed at baseline among a group of patients selected for a separate randomized clinical trial on the basis of better psychosocial adaptation. CONCLUSION: The 6-session CBT intervention for patients with heightened psychologic and psychosocial disability was effective in improving pain-related variables over the course of the CBT in conjunction with usual treatment, but was too brief an intervention to result in further improvement after the sessions ended. Patient ratings of treatment satisfaction and helfulness were high for both groups, but they were significantly higher for the comprehensive care group.

A randomized clinical trial using research diagnostic criteria for temporomandibular disorders-axis II to target clinic cases for a tailored self-care TMD treatment program.

AIMS: To carry out a randomized clinical trial (RCT) contrasting usual conservative treatment of TMD by clinical TMD specialists with a structured self-care intervention, targeted to clinic cases independent of TMD physical diagnosis, who were reporting minimal levels of psychosocial dysfunction; the intervention was delivered by dental hygienists in lieu of usual treatment. METHODS: The Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) was used to target subjects who exhibited minimal TMD-related psychosocial interference. Criteria for study inclusion were: (1) self-report of facial and/or masticatory muscle pain discomfort for which usual care was prescribed by the clinic TMD specialist; (2) RDC/TMD Axis II graded scale of chronic pain (GCP) score of 0, I, or II-Low. (3) Age 18 to 70 years. RESULTS: On 1-year follow-up, while both groups showed improvement in all clinical and self-report categories measured, patients in the tailored self-care treatment program compared to usual TMD treatment showed significantly; (a) decreased TMD pain, (b) decreased pain-related interference in activity; (c) reduced number of masticatory muscles painful; (d) fewer additional visits for TMD treatment. Groups were comparable with regard to measures of vertical range of motion. The self-care program was associated with consistent, but non-statistically significant, trends towards lower levels of depression and somatization. Ability to cope with TMD, knowledge concerning TMD and patient satisfaction was significantly enhanced for the self-care group. No participating patients experienced physical or personal adverse effects during the 1-year post-treatment follow-up period. CONCLUSION: Use of RDC/TMD psychosocial assessment criteria can contribute to successful clinical decision-making for the management of TMD.