Chiropractor interaction and treatment equivalence in a pilot randomized controlled trial: an observational analysis of clinical encounter video-recordings

Stacie A Salsbury, James W DeVocht, Maria A Hondras, Michael B Seidman, Clark M Stanford, Christine M Goertz, Stacie A Salsbury, James W DeVocht, Maria A Hondras, Michael B Seidman, Clark M Stanford, Christine M Goertz

Abstract

Background: Chiropractic care is a complex health intervention composed of both treatment effects and non-specific, or placebo, effects. While doctor-patient interactions are a component of the non-specific effects of chiropractic, these effects are not evaluated in most clinical trials. This study aimed to: 1) develop an instrument to assess practitioner-patient interactions; 2) determine the equivalence of a chiropractor's verbal interactions and treatment delivery for participants allocated to active or sham chiropractic groups; and 3) describe the perceptions of a treatment-masked evaluator and study participants regarding treatment group assignment.

Methods: We conducted an observational analysis of digital video-recordings derived from study visits conducted during a pilot randomized trial of conservative therapies for temporomandibular pain. A theory-based, iterative process developed the 13-item Chiropractor Interaction and Treatment Equivalence Instrument. A trained evaluator masked to treatment assignment coded video-recordings of clinical encounters between one chiropractor and multiple visits of 26 participants allocated to active or sham chiropractic treatment groups. Non-parametric statistics were calculated.

Results: The trial ran from January 2010 to October 2011. We analyzed 111 complete video-recordings (54 active, 57 sham). Chiropractor interactions differed between the treatment groups in 7 categories. Active participants received more interactions with clinical information (8 vs. 4) or explanations (3.5 vs. 1) than sham participants within the therapeutic domain. Active participants received more directions (63 vs. 58) and adjusting instrument thrusts (41.5 vs. 23) in the procedural domain and more optimistic (2.5 vs. 0) or neutral (7.5 vs. 5) outcome statements in the treatment effectiveness domain. Active participants recorded longer visit durations (13.5 vs. 10 minutes). The evaluator correctly identified 61% of active care video-recordings as active treatments but categorized only 31% of the sham treatments correctly. Following the first treatment, 82% of active and 11% of sham participants correctly identified their treatment group. At 2-months, 93% of active and 42% of sham participants correctly identified their group assignment.

Conclusions: Our findings show the feasibility of evaluating doctor-patient interactions in chiropractic clinical trials using video-recordings and standardized instrumentation. Clinical trial design and clinician training protocols should improve and assess the equivalence of doctor-patient interactions between treatment groups.

Trial registration: This trial was registered in ClinicalTrials.gov as NCT01021306 on 24 November 2009.

Keywords: Chiropractic; Musculoskeletal manipulations; Observational study; Physician-patient relations; Placebo effect; Randomized controlled trials; Sham treatment; Verbal behavior; Video recording.

Figures

Figure 1
Figure 1
Chiropractor Interaction and Treatment Equivalence Instrument (CITE-I).
Figure 2
Figure 2
Video-recording flowchart.

References

    1. Campbell NC, Murray E, Darbyshire J, Emery J, Farmer A, Griffiths F, Guthrie B, Lester H, Wilson P, Kinmonth AL. Designing and evaluating complex interventions to improve health care. BMJ. 2007;334(7591):455–459. doi: 10.1136/.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi: 10.1136/bmj.a1655.
    1. Paterson C, Dieppe P. Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ. 2005;330(7501):1202–1205. doi: 10.1136/bmj.330.7501.1202.
    1. Jones CH. The spectrum of therapeutic influences and integrative health care: classifying health care practices by mode of therapeutic action. J Altern Complement Med. 2005;11(5):937–944. doi: 10.1089/acm.2005.11.937.
    1. Herzog W. The biomechanics of spinal manipulation. J Bodywork Mov Ther. 2010;14(3):280–286. doi: 10.1016/j.jbmt.2010.03.004.
    1. Graham BA, Clausen P, Bolton PS. A descriptive study of the force and displacement profiles of the toggle-recoil spinal manipulative procedure (adjustment) as performed by chiropractors. Man Ther. 2010;15(1):74–79. doi: 10.1016/j.math.2009.07.003.
    1. Bronfort G, Haas M, Evans R, Kawchuk G, Dagenais S. Evidence-informed management of chronic low back pain with spinal manipulation and mobilization. Spine J. 2008;8(1):213–225. doi: 10.1016/j.spinee.2007.10.023.
    1. Downie AS, Vemulpad S, Bull PW. Quantifying the high-velocity, low-amplitude spinal manipulative thrust: a systematic review. J Manipulative Physiol Ther. 2010;33(7):542–553. doi: 10.1016/j.jmpt.2010.08.001.
    1. Kawchuk GN, Herzog W. Biomechanical characterization (fingerprinting) of five novel methods of cervical spine manipulation. J Manipulative Physiol Ther. 1992;16(9):573–577.
    1. DeVocht JW, Owens EF, Gudavalli MR, Strazewski J, Bhogal R, Xia T. Force-time profile differences in the delivery of simulated toggle-recoil spinal manipulation by students, instructors, and field doctors of chiropractic. J Manipulative Physiol Ther. 2013;36(6):342–348. doi: 10.1016/j.jmpt.2013.05.027.
    1. Nambi SG, Inbasekaran D, Khuman R, Devi S, Satani K. Clinical effects of short and long lever spinal thrust manipulation in non-specific chronic low back pain: a biomechanical perspective. Int J Health Allied Sci. 2013;2(4):230–236. doi: 10.4103/2278-344X.126706.
    1. McGregor M, Puhl A, Reinhart C, Injeyan H, Soave D. Differentiating intraprofessional attitudes toward paradigms in health care delivery among chiropractic factions: results from a randomly sampled survey. BMC Complement Altern Med. 2014;14(1):51. doi: 10.1186/1472-6882-14-51.
    1. Smith M, Carber LA. Survey of US chiropractor attitudes and behaviors about subluxation. J Chiropr Human. 2008;15:19–26. doi: 10.1016/S1556-3499(13)60166-7.
    1. Murphy DR, Schneider MJ, Seaman DR, Perle SM, Nelson CF. How can chiropractic become a respected mainstream profession? The example of podiatry. Chiropr Osteop. 2008;16:10. doi: 10.1186/1746-1340-16-10.
    1. Gleberzon B, Stuber K. Frequency of use of diagnostic and manual therapeutic procedures of the spine currently taught at the Canadian Memorial Chiropractic College: a preliminary survey of Ontario chiropractors. Part 2 − procedure usage rates. J Can Chiropr Assoc. 2013;57(2):165–175.
    1. Mykietiuk C, Wambolt M, Pillipow T, Mallay C, Gleberzon BJ. Technique Systems used by post-1980 graduates of the Canadian Memorial Chiropractic College practicing in five Canadian provinces: a preliminary survey. J Can Chiropr Assoc. 2009;53(1):32–39.
    1. Huggins T, Boras AL, Gleberzon BJ, Popescu M, Bahry LA. Clinical effectiveness of the activator adjusting instrument in the management of musculoskeletal disorders: a systematic review of the literature. J Can Chiropr Assoc. 2012;56(1):49–57.
    1. Gleberzon BJ. Chiropractic “name techniques”: a review of the literature. J Can Chiropr Assoc. 2001;45(2):86–99.
    1. Christensen MG, Kollasch MW, Hyland JK. Practice Analysis of Chiropractic 2010: A Project Report, Survey Analysis, and Summary of Chiropractic Practice in the United States. Greeley, CO: National Board of Chiropractic Examiners; 2010.
    1. Haas M, Spegman A, Peterson D, Aickin M, Vavrek D. Dose response and efficacy of spinal manipulation for chronic cervicogenic headache: a pilot randomized controlled trial. Spine J. 2010;10(2):117–128. doi: 10.1016/j.spinee.2009.09.002.
    1. Witt CM, Schützler L. The gap between results from sham-controlled trials and trials using other controls in acupuncture research: the influence of context. Complement Ther Med. 2013;21(2):112–114. doi: 10.1016/j.ctim.2012.12.005.
    1. Gay C, Bishop M. Research on placebo analgesia is relevant to clinical practice. Chiropr Man Therap. 2014;22(1):6. doi: 10.1186/2045-709X-22-6.
    1. Brim RL, Miller FG. The potential benefit of the placebo effect in sham-controlled trials: implications for risk-benefit assessments and informed consent. J Med Ethics. 2013;39(11):703–707. doi: 10.1136/medethics-2012-101045.
    1. Hróbjartsson A, Gøtzsche PC. Placebo interventions for all clinical conditions. Cochrane Database Syst Rev. 2010;1:CD003974.
    1. Puhl AA, Reinhart CJ, Rok ER, Injeyan HS. An examination of the observed placebo effect associated with the treatment of low back pain: a systematic review. Pain Res Manag. 2011;16(1):45–52.
    1. Krogsbll LT, Hróbjartsson A, Gøtzsche PC. Spontaneous improvement in randomised clinical trials: meta-analysis of three-armed trials comparing no treatment, placebo and active intervention. BMC Med Res Methodol. 2009;9(1):1. doi: 10.1186/1471-2288-9-1.
    1. Licciardone JC, Russo DP. Blinding protocols, treatment credibility, and expectancy: methodologic issues in clinical trials of osteopathic manipulative treatment. J Am Osteopath Assoc. 2006;106(8):457–463.
    1. Kaptchuk TJ, Kelley JM, Conboy LA, Davis RB, Kerr CE, Jacobson EE, Kirsch I, Schyner RN, Nam BH, Nguyen LT. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ. 2008;336(7651):999–1003. doi: 10.1136/bmj.39524.439618.25.
    1. Kaptchuk TJ. The placebo effect in alternative medicine: can the performance of a healing ritual have clinical significance? Ann Intern Med. 2002;136(11):817–825. doi: 10.7326/0003-4819-136-11-200206040-00011.
    1. Kaptchuk TJ, Shaw J, Kerr CE, Conboy LA, Kelley JM, Csordas TJ, Lembo AJ, Jacobson EE. “Maybe I made up the whole thing”: placebos and patients' experiences in a randomized controlled trial. Cult Med Psychiatry. 2009;33(3):382–411. doi: 10.1007/s11013-009-9141-7.
    1. Finniss DG, Kaptchuk TJ, Miller F, Benedetti F. Biological, clinical, and ethical advances of placebo effects. Lancet. 2010;375(9715):686–695. doi: 10.1016/S0140-6736(09)61706-2.
    1. Price DD, Finniss DG, Benedetti F. A comprehensive review of the placebo effect: recent advances and current thought. Annu Rev Psychol. 2008;59:565–590. doi: 10.1146/annurev.psych.59.113006.095941.
    1. Bialosky JE, Bishop MD, Robinson ME, Barabas JA, George SZ. The influence of expectation on spinal manipulation induced hypoalgesia: an experimental study in normal subjects. BMC Musculoskelet Disord. 2008;9:19. doi: 10.1186/1471-2474-9-19.
    1. Bensing JM, Verheul W. The silent healer: the role of communication in placebo effects. Patient Educ Couns. 2010;80(3):293–299. doi: 10.1016/j.pec.2010.05.033.
    1. Paterson C, Zheng Z, Xue C, Wang Y. “Playing their parts”: the experiences of participants in a randomized sham-controlled acupuncture trial. J Altern Complement Med. 2008;14(2):199–208. doi: 10.1089/acm.2007.0682.
    1. Ernst E, Harkness E. Spinal manipulation: a systematic review of sham-controlled, double-blind, randomized clinical trials. J Pain Symptom Manag. 2001;22(4):879–889. doi: 10.1016/S0885-3924(01)00337-2.
    1. Hawk C, Azad A, Phongphua C, Long CR. Preliminary study of the effects of a placebo chiropractic treatment with sham adjustments. J Manipulative Physiol Ther. 1999;22(7):436–443. doi: 10.1016/S0161-4754(99)70031-X.
    1. Miller FG, Emanuel EJ, Rosenstein DL, Straus SE. Ethical issues concerning research in complementary and alternative medicine. JAMA. 2004;291(5):599–604. doi: 10.1001/jama.291.5.599.
    1. Margolin A, Avants SK, Kleber HD. Investigating alternative medicine therapies in randomized controlled trials. JAMA. 1998;280(18):1626–1628. doi: 10.1001/jama.280.18.1626.
    1. Schulz KF, Altman DG, Moher D, CONSORT Group CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010;8(1):18. doi: 10.1186/1741-7015-8-18.
    1. Goertz CM, Pohlman KA, Vining RD, Brantingham JW, Long CR. Patient-centered outcomes of high-velocity, low-amplitude spinal manipulation for low back pain: a systematic review. J Electromyogr Kinesiol. 2012;22(5):670–691. doi: 10.1016/j.jelekin.2012.03.006.
    1. Khorsan R, Coulter ID, Hawk C, Choate CG. Measures in chiropractic research: choosing patient-based outcome assessments. J Manipulative Physiol Ther. 2008;31(5):355–375. doi: 10.1016/j.jmpt.2008.04.007.
    1. Sikorskii A, Wyatt G, Victorson D, Faulkner G, Rahbar MH. Methodological issues in trials of complementary and alternative medicine interventions. Nurs Res. 2009;58(6):444–451. doi: 10.1097/NNR.0b013e3181bf15fe.
    1. DeVocht JW, Goertz CM, Hondras MA, Long CR, Schaeffer W, Thomann L, Spector M, Stanford CM. A pilot study of a chiropractic intervention for management of chronic myofascial temporomandibular disorder. J Am Dent Assoc. 2013;144(10):1154–1163. doi: 10.14219/jada.archive.2013.0034.
    1. Fuhr AW, Menke JM. Status of activator methods chiropractic technique, theory, and practice. J Manipulative Physiol Ther. 2005;28(2):e1–e20. doi: 10.1016/j.jmpt.2005.01.001.
    1. Farrar JT, Young JP, Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94(2):149–158. doi: 10.1016/S0304-3959(01)00349-9.
    1. Locker D, Allen PF. Developing short-form measures of oral health-related quality of life. J Public Health Dent. 2002;62(1):13–20. doi: 10.1111/j.1752-7325.2002.tb03415.x.
    1. Epstein RM, Franks P, Fiscella K, Shields CG, Meldrum SC, Kravitz RL, Duberstein PR. Measuring patient-centered communication in patient−physician consultations: theoretical and practical issues. Soc Sci Med. 2005;61(7):1516–1528. doi: 10.1016/j.socscimed.2005.02.001.
    1. Roter D, Larson S. The Roter interaction analysis system (RIAS): utility and flexibility for analysis of medical interactions. Patient Educ Couns. 2002;46(4):243–251. doi: 10.1016/S0738-3991(02)00012-5.
    1. Ong L, De Haes J, Hoos A, Lammes FB. Doctor-patient communication: a review of the literature. Soc Sci Med. 1995;40(7):903–918. doi: 10.1016/0277-9536(94)00155-M.
    1. Barlow F, Scott C, Coghlan B, Lee P, White P, Lewith GT, Bishop FL. How the psychosocial context of clinical trials differs from usual care: A qualitative study of acupuncture patients. BMC Med Res Methodol. 2011;11(1):79. doi: 10.1186/1471-2288-11-79.
    1. White AR, Filshie J, Cummings TM. Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding. Complement Ther Med. 2001;9(4):237–245. doi: 10.1054/ctim.2001.0489.
    1. Sidani S, Braden CJ. Evaluating Nursing Interventions: A Theory-Driven Approach. Thousand Oaks, CA: SAGE Publications; 1998.
    1. Desjarlais-deKlerk K, Wallace J. Instrumental and socioemotional communications in doctor-patient interactions in urban and rural clinics. BMC Health Serv Res. 2013;13(1):261. doi: 10.1186/1472-6963-13-261.
    1. Carroll C, Patterson M, Wood S, Booth A, Rick J, Balain S. A conceptual framework for implementation fidelity. Implement Sci. 2007;2(40):1–9.
    1. Scholten-Peeters GG, Thoomes E, Konings S, Beijer M, Verkerk K, Koes BW, Verhagen AP. Is manipulative therapy more effective than sham manipulation in adults? A systematic review and meta-analysis. Chiropr Man Therap. 2013;21(1):34. doi: 10.1186/2045-709X-21-34.
    1. Reed WR, Beavers S, Reddy SK, Kern G. Chiropractic management of primary nocturnal enuresis. J Manipulative Physiol Ther. 1994;17(9):596–600.
    1. Sawyer CE, Evans RL, Boline PD, Branson R, Spicer A. A feasibility study of chiropractic spinal manipulation versus sham spinal manipulation for chronic otitis media with effusion in children. J Manipulative Physiol Ther. 1999;22(5):292–298. doi: 10.1016/S0161-4754(99)70061-8.
    1. Vernon H, MacAdam K, Marshall V, Pion M, Sadowska M. Validation of a sham manipulative procedure for the cervical spine for use in clinical trials. J Manipulative Physiol Ther. 2005;28(9):662–666. doi: 10.1016/j.jmpt.2005.07.020.
    1. Brose SW, Jennings DC, Kwok J, Stuart CL, O'Connell SM, Pauli HA, Liu B. Sham manual medicine protocol for cervical strain-counterstrain research. PM&R. 2013;5(5):400–407. doi: 10.1016/j.pmrj.2013.01.005.
    1. Vernon HT, Triano JJ, Ross JK, Tran SK, Soave DM, Dinulos MD. Validation of a novel sham cervical manipulation procedure. Spine J. 2012;12(11):1021–1028. doi: 10.1016/j.spinee.2012.10.009.
    1. Ozcakar N, Mevsim V, Guldal D, Gunvar T, Yildirim E, Sisli Z, Semin I. Is the use of videotape recording superior to verbal feedback alone in the teaching of clinical skills? BMC Public Health. 2009;9(1):474. doi: 10.1186/1471-2458-9-474.
    1. Kihlgren M, Kuremyr D, Norberg A, Brane G, Karlson I, Engstrom B, Melin E. Nurse-patient interaction after training in integrity promoting care at a long-term ward: analysis of video-recorded morning care sessions. Int J Nurs Stud. 1993;30(1):1–13. doi: 10.1016/0020-7489(93)90088-C.
    1. Mackenzie CF, Xiao Y. Video techniques and data compared with observation in emergency trauma care. Qual Saf Health Care. 2003;12(suppl 2):ii51–ii57.
    1. Marcinowicz L, Konstantynowicz J, Godlewski C. Patients' perceptions of GP non-verbal communication: a qualitative study. Br J Gen Pract. 2010;60(571):83–87. doi: 10.3399/bjgp10X483111.
    1. Cocksedge S, George B, Renwick S, Chew-Graham CA. Touch in primary care consultations: qualitative investigation of doctors’ and patients’ perceptions. Br J Gen Pract. 2013;63(609):e283–e290. doi: 10.3399/bjgp13X665251.
    1. Swayden KJ, Anderson KK, Connelly LM, Moran JS, McMahon JK, Arnold PM. Effect of sitting vs. standing on perception of provider time at bedside: a pilot study. Patient Educ Couns. 2012;86(2):166–171. doi: 10.1016/j.pec.2011.05.024.
    1. Coleman T. Using video-recorded consultations for research in primary care: advantages and limitations. Fam Pract. 2000;17(5):422–427. doi: 10.1093/fampra/17.5.422.
    1. Latvala E, Vuokila-Oikkonen P, Janhonen S. Videotaped recording as a method of participant observation in psychiatric nursing research. J Adv Nurs. 2000;31(5):1252–1257. doi: 10.1046/j.1365-2648.2000.01383.x.
    1. Caldwell K, Atwal A. Non-participant observation: using video tapes to collect data in nursing research. Nurse Res. 2005;13(2):42–54. doi: 10.7748/nr2005.10.13.2.42.c5967.
    1. Ram P, Grol R, Rethans JJ, Schouten B, van der Vleuten C, Kester A. Assessment of general practitioners by video observation of communicative and medical performance in daily practice: issues of validity, reliability and feasibility. Med Educ. 1999;33(6):447–454. doi: 10.1046/j.1365-2923.1999.00348.x.
    1. Oakley E, Stocker S, Staubli G, Young S. Using video recording to identify management errors in pediatric trauma resuscitation. Pediatrics. 2006;117(3):658–664. doi: 10.1542/peds.2004-1803.
    1. Penner LA, Orom H, Albrecht TL, Franks MM, Foster TS, Ruckdeschel JC. Camera-related behaviors during video recorded medical interactions. J Nonverbal Behav. 2007;31(2):99–117. doi: 10.1007/s10919-007-0024-8.
    1. Pringle M, Stewart-Evans C. Does awareness of being video recorded affect doctors’ consultation behaviour? Br J Gen Pract. 1990;40(340):455–458.
    1. Rex DK, Hewett DG, Raghavendra M, Chalasani N. The impact of videorecording on the quality of colonoscopy performance: a pilot study. Am J Gastroenterol. 2010;105(11):2312–2317. doi: 10.1038/ajg.2010.245.
    1. Innes M, Skelton J, Greenfield S. A profile of communication in primary care physician telephone consultations: application of the Roter Interaction Analysis System. Br J Gen Pract. 2006;56(526):363–368.
    1. Paasche-Orlow M, Roter D. The communication patterns of internal medicine and family practice physicians. J Am Board Fam Prac. 2003;16(6):485–493. doi: 10.3122/jabfm.16.6.485.
    1. Bensing JM, Roter DL, Hulsman RL. Communication patterns of primary care physicians in the United States and The Netherlands. J Gen Internal Med. 2003;18(5):335–342. doi: 10.1046/j.1525-1497.2003.10735.x.
    1. Shaw JR, Adams CL, Bonnett BN, Larson S, Roter DL. Use of the Roter interaction analysis system to analyze veterinarian-client-patient communication in companion animal practice. J Am Vet Med Assoc. 2004;225(2):222–229. doi: 10.2460/javma.2004.225.222.
    1. Ong LM, Visser MR, Kruyver IP, Bensing JM, Brink-Muinen A, Stouthard JM, Lammes FB, de Haes JC. The Roter Interaction Analysis System (RIAS) in oncological consultations: psychometric properties. Psychooncology. 1998;7(5):387–401. doi: 10.1002/(SICI)1099-1611(1998090)7:5<387::AID-PON316>;2-G.

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