title: Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain.
abstract: BACKGROUND
  Manual 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.
  
  
  METHODS
  We 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.
  
  
  RESULTS
  We 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.
  
  
  CONCLUSIONS
  This 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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01765751 (Registration Date 30 May 2012).
authors.affiliation: Palmer Center for Chiropractic Research, Palmer College of Chiropractic, 741 Brady Street, 52803, Davenport, IA, USA. gudavalli_r@palmer.edu.
authors.forename: M Ram
authors.initials: MR
authors.lastname: Gudavalli
authors.affiliation: Palmer Center for Chiropractic Research, Palmer College of Chiropractic, 741 Brady Street, 52803, Davenport, IA, USA. stacie.salsbury@palmer.edu.
authors.forename: Stacie A
authors.initials: SA
authors.lastname: Salsbury
authors.affiliation: Palmer Center for Chiropractic Research, Palmer College of Chiropractic, 741 Brady Street, 52803, Davenport, IA, USA. robert.vining@palmer.edu.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Vining
authors.affiliation: Palmer Center for Chiropractic Research, Palmer College of Chiropractic, 741 Brady Street, 52803, Davenport, IA, USA. LONG_C@palmer.edu.
authors.forename: Cynthia R
authors.initials: CR
authors.lastname: Long
authors.affiliation: Palmer Center for Chiropractic Research, Palmer College of Chiropractic, 741 Brady Street, 52803, Davenport, IA, USA. CORBER_L@palmer.edu.
authors.forename: Lance
authors.initials: L
authors.lastname: Corber
authors.affiliation: Musculoskeletal Biomechanics Laboratory, Edward Hines Jr. VA Hospital, Hines, IL and Department of Orthopedic Surgery & Rehabilitation, Stritch School of Medicine, Loyola University Chicago, Chicago, IL, USA. apatwar@lumc.edu.
authors.forename: Avinash G
authors.initials: AG
authors.lastname: Patwardhan
authors.affiliation: Palmer Center for Chiropractic Research, Palmer College of Chiropractic, 741 Brady Street, 52803, Davenport, IA, USA. christine.goertz@palmer.edu.
authors.forename: Christine M
authors.initials: CM
authors.lastname: Goertz
mesh_terms: D000328:Adult; D000368:Aged; D001288:Attention; D001696:Biomechanical Phenomena; D002574:Cervical Vertebrae / Q000503:physiopathology*; D004185:Disability Evaluation; D004867:Equipment Design; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D007484:Iowa; D008297:Male; D020393:Manipulation, Spinal / Q000295:instrumentation / Q000379:methods*; D008875:Middle Aged; D019547:Neck Pain / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D010147:Pain Measurement; D056888:Patient Positioning; D017060:Patient Satisfaction; D010865:Pilot Projects; D011237:Predictive Value of Tests; D016684:Prone Position; D020127:Recovery of Function; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D055698:Touch Perception; D014143:Traction / Q000295:instrumentation / Q000379:methods*; D016896:Treatment Outcome