Dose-response and efficacy of spinal manipulation for chronic cervicogenic headache: A pilot randomized controlled trial

Center for Outcomes Studies, Western States Chiropractic College, 2900 NE 132nd Ave., Portland, OR 97230, USA.
The spine journal: official journal of the North American Spine Society (Impact Factor: 2.43). 10/2009; 10(2):117-28. DOI: 10.1016/j.spinee.2009.09.002
Source: PubMed

ABSTRACT Systematic reviews of randomized controlled trials suggest that spinal manipulative therapy (SMT) is efficacious for care of cervicogenic headache (CGH). The effect of SMT dose on outcomes has not been studied.
To compare the efficacy of two doses of SMT and two doses of light massage (LM) for CGH.
Eighty patients with chronic CGH.
Modified Von Korff pain and disability scales for CGH and neck pain (minimum clinically important difference=10 on 100-point scale), number of headaches in the last 4 weeks, and medication use. Data were collected every 4 weeks for 24 weeks. The primary outcome was the CGH pain scale.
Participants were randomized to either 8 or 16 treatment sessions with either SMT or a minimal LM control. Patients were treated once or twice per week for 8 weeks. Adjusted mean differences (AMD) between groups were computed using generalized estimating equations for the longitudinal outcomes over all follow-up time points (profile) and using regression modeling for individual time points with baseline characteristics as covariates and with imputed missing data.
For the CGH pain scale, comparisons of 8 and 16 treatment sessions yielded small dose effects: |AMD|</=5.6. There was an advantage for SMT over the control: AMD=-8.1 (95% confidence interval=-13.3 to -2.8) for the profile, -10.3 (-18.5 to -2.1) at 12 weeks, and -9.8 (-18.7 to -1.0) at 24 weeks. For the higher dose patients, the advantage was greater: AMD=-11.9 (-19.3 to -4.6) for the profile, -14.2 (-25.8 to -2.6) at 12 weeks, and -14.4 (-26.9 to -2.0) at 24 weeks. Patients receiving SMT were also more likely to achieve a 50% improvement in pain scale: adjusted odds ratio=3.6 (1.6 to 8.1) for the profile, 3.1 (0.9 to 9.8) at 12 weeks, and 3.1 (0.9 to 10.3) at 24 weeks. Secondary outcomes showed similar trends favoring SMT. For SMT patients, the mean number of CGH was reduced by half.
Clinically important differences between SMT and a control intervention were observed favoring SMT. Dose effects tended to be small.

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Available from: Darcy Vavrek, Sep 26, 2015
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    • "With this in mind, we took steps in an earlier dose–response trial on spinal manipulation for cervicogenic headache to help minimize the effects of expectation and the doctor-patient encounter (DPE) [13,14]. Chiropractors were asked to interact with the study participants with uniform enthusiasm across study groups. "
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    ABSTRACT: The doctor-patient encounter (DPE) and associated patient expectations are potential confounders in open-label randomized trials of treatment efficacy. It is therefore important to evaluate the effects of the DPE on study outcomes. Four hundred participants with chronic low back pain (LBP) were randomized to four dose groups: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated three times per week for six weeks. They received light massage control at visits when manipulation was not scheduled. Treating chiropractors were instructed to have equal enthusiasm for both interventions. A path analysis was conducted to determine the effects of dose, patient expectations of treatment success, and DPE on LBP intensity (100-point scale) at the end of care (6 weeks) and primary endpoint (12 weeks). Direct, indirect, and total standardized effects (betatotal) were computed. Expectations and DPE were evaluated on Likert scales. The DPE was assessed as patient-rated perception of chiropractor enthusiasm, confidence, comfort with care, and time spent. The DPE was successfully balanced across groups, as were baseline expectations. The principal finding was that the magnitude of the effects of DPE on LBP at 6 and 12 weeks (|beta|total = 0.22 and 0.15, p < .05) were comparable to the effects of dose of manipulation at those times (|beta|total = 0.11 and 0.12, p < .05). In addition, baseline expectations had no notable effect on follow-up LBP. Subsequent expectations were affected by LBP, DPE, and dose (p < .05). The DPE can have a relatively important effect on outcomes in open-label randomized trials of treatment efficacy. Therefore, attempts should be made to balance the DPE across treatment groups and report degree of success in study publications. We balanced the DPE across groups with minimal training of treatment providers.Trial registration: NCT00376350.
    BMC Complementary and Alternative Medicine 01/2014; 14(1):16. DOI:10.1186/1472-6882-14-16 · 2.02 Impact Factor
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    • "Secondary outcomes included pain unpleasantness [27], Physical and Mental Component Summary Scales of the short-form 12 [28], Health State Visual Analog Scale from EuroQol [29], perceived pain and disability improvement , and the number of the following in the previous 4 weeks: days with pain and disability and medication use. Additional baseline variables included demographics, Fear-Avoidance Beliefs Questionnaire [30], confidence in treatment success [14], and any from a list of comorbid conditions (arthritis, asthma or allergies, gastrointestinal problems, gynecological problems, hypertension, or other chronic condition) [31]. "
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    ABSTRACT: There have been no full-scale trials of the optimal number of visits for the care of any condition with spinal manipulation. To identify the dose-response relationship between visits to a chiropractor for spinal manipulation and chronic low back pain (cLBP) outcomes and to determine the efficacy of manipulation by comparison with a light massage control. Practice-based randomized controlled trial. Four hundred participants with cLBP. The primary cLBP outcomes were the 100-point modified Von Korff pain intensity and functional disability scales evaluated at the 12- and 24-week primary end points. Secondary outcomes included days with pain and functional disability, pain unpleasantness, global perceived improvement, medication use, and general health status. One hundred participants with cLBP were randomized to each of four dose levels of care: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated three times per week for 6 weeks. At sessions when manipulation was not assigned, they received a focused light massage control. Covariate-adjusted linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 18, 24, 39, and 52 weeks. For the primary outcomes, mean pain and disability improvement in the manipulation groups were 20 points by 12 weeks and sustainable to 52 weeks. Linear dose-response effects were small, reaching about two points per six manipulation sessions at 12 and 52 weeks for both variables (p<.025). At 12 weeks, the greatest differences from the no-manipulation control were found for 12 sessions (8.6 pain and 7.6 disability points, p<.025); at 24 weeks, differences were negligible; and at 52 weeks, the greatest group differences were seen for 18 visits (5.9 pain and 8.8 disability points, p<.025). The number of spinal manipulation visits had modest effects on cLBP outcomes above those of 18 hands-on visits to a chiropractor. Overall, 12 visits yielded the most favorable results but was not well distinguished from other dose levels.
    The spine journal: official journal of the North American Spine Society 10/2013; 14(7). DOI:10.1016/j.spinee.2013.07.468 · 2.43 Impact Factor
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    • "Six singly recommended articles address interdisciplinary clinical decision-making for the care of patients with low back pain [40-42,50,59,72], while two texts highlight treatment approaches to neck pain and related conditions [45,55]. Five articles report findings from clinical trials of manual therapies or spinal manipulation [43,46,53,57,60], while three other papers discuss either ineffective applications, [47,65] or common side effects of manipulation [44]. Lastly, nine articles demonstrate chiropractic research priorities [30,73,74], analyze health policy issues for the chiropractic profession [14,51,69], or discuss evidence-based practice concepts for doctors and students of chiropractic [67,70,71]. "
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    ABSTRACT: Evidence-based clinical practice (EBCP) is an accepted practice for informed clinical decision making in mainstream health care professions. EBCP augments clinical experience and can have far reaching effects in education, policy, reimbursement and clinical management. The proliferation of published research can be overwhelming-finding a mechanism to identify literature that is essential for practitioners and students is desirable. The purpose of this study was to survey leaders in the chiropractic profession on their opinions of essential literature for doctors of chiropractic, faculty, and students to read or reference. Deployment of an IRB exempted survey occurred with 68 academic and research leaders using SurveyMonkey®. Individuals were solicited via e-mail in August of 2011; the study closed in October of 2011. Forty-three (43) individuals consented to participate; seventeen (17) contributed at least one article of importance. A total of 41 unique articles were reported. Of the six articles contributed more than once, one article was reported 6 times, and 5 were reported twice. A manageable list of relevant literature was created. Shortcomings of methods were identified, and improvements for continued implementation are suggested. A wide variety of articles were reported as "essential" knowledge; annual or bi-annual surveys would be helpful for the profession.
    Chiropractic and Manual Therapies 09/2013; 21(1):33. DOI:10.1186/2045-709X-21-33
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