Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain

Abstract

BackgroundManual cervical distraction (MCD) is a traction-based therapy performed with a manual contact over the cervical region producing repeating cycles while patients lie prone. This study evaluated a traction force-based minimal intervention for use as an attention-touch control in clinical trials of MCD for patients with chronic neck pain.MethodsWe conducted a mixed-methods, pilot randomized clinical trial in adults with chronic neck pain. Participants were allocated to three traction force ranges of MCD: low force/minimal intervention (0-20 N), medium force (21-50 N), or high force (51-100 N). Clinicians delivered five treatments over two weeks consisting of three sets of five cycles of MCD at the C5 vertebra and occiput. Traction forces were measured at each treatment. Patient-reported outcomes included a pain visual analogue scale (VAS), Neck Disability Index (NDI), Credibility and Expectancy Questionnaire (CEQ), and adverse effects. A qualitative interview evaluated treatment group allocation perceptions.ResultsWe randomized 48 participants, allocating an average of five each month. Forty-five participants completed the trial with three participants lost to follow-up. Most participants were women (65 %) and white (92 %) with a mean (SD) age of 46.8 (12.5) years. Mean traction force values were within the prescribed force ranges for each group at the C5 and occiput levels. Neck pain VAS demonstrated a benefit for high traction force MCD compared to the low force group [adjusted mean difference 15.6; 95 % confidence interval (CI) 1.6 to 29.7]. Participants in the medium traction force group demonstrated improvements in NDI compared to the low force group (adjusted mean difference 3.0; 95 % CI 0.1 to 5.9), as did participants in the high traction force group (adjusted mean difference 2.7; 95 % CI -0.1 to 5.6). CEQ favored the high force group. Most low force participants correctly identified their treatment allocation in the qualitative interview. No serious adverse events were documented.ConclusionsThis pilot study demonstrated the feasibility of a clinical trial protocol and the utility of a traction-based, minimal intervention as an attention-touch control for future efficacy trials of MCD for patients with neck pain.Trial registrationClinicalTrials.gov NCT01765751 (Registration Date 30 May 2012)

Spinal manipulation frequency and dosage effects on clinical and physiological outcomes: a scoping review

“…Seven randomized control trials were assessed for quality, of which six, reported on the effects of SM frequency [13–18] including four pilot studies [13, 14, 16, 18] and one reported on the dosage effects [21]. Four studies [13, 14, 16, 18] presented a high risk for other bias because they did not report an a priori sample size calculation and included between 24 to 80 participants.…”

“…The majority of studies (25/26) [10, 19, 20, 22–31, 33–39, 41–44] reported on the physiological outcomes of SM and one reported on the clinical outcomes of SM in a neck pain population [21].…”

“…One pilot randomized control trial investigated the effects of three different manually-delivered cervical traction forces (low, medium and high) in 48 participants experiencing chronic neck pain. Results suggest that high-force tractions significantly improve neck pain compared to low-force tractions whereas, improvements in disability were significantly greater for medium and high-force tractions compared to low-force tractions [21].…”

Factors Associated With Clinical Responses to Spinal Manipulation in Patients With Non-specific Thoracic Back Pain: A Prospective Cohort Study

“…The STAI-YB or Trait questionnaire evaluates general states of calmness, confidence, and security. A total score of the YA and YB questionnaires gives a rate of anxiety that can be classified as very low (0-35), low (36)(37)(38)(39)(40)(41)(42)(43)(44)(45) moderate (46)(47)(48)(49)(50)(51)(52)(53)(54)(55), high (56-65), and severe (>65) for each questionnaire (30,31). Finally, the level of comfort during SMT was assessed following the intervention, using a 100-mm scale, a higher score indicating a very comfortable procedure and a lower score a very uncomfortable one.…”

Evidence-Based Evaluation of Complementary Health Approaches for Pain Management in the United States

“…There was one RCT of manual cervical distraction, 86 a traction-based therapy with low, medium, and high forces assessed. The goal of the study was to identify a viable sham-control (see Supplemental Table 3 for details).…”