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Dose response and efficacy of spinal manipulation for chronic cervicogenic headache: a pilot randomized controlled trial. Mitchell Hass, et al. IF: 3.024 . Introduction. CONSORT checklist results were good Headaches are a common pain condition

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slide1

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

Mitchell Hass, et al.

IF: 3.024 

introduction
Introduction
  • CONSORT checklist results were good
  • Headaches are a common pain condition
    • Cervicogenic headache (CGH) is within the top 3 headaches
  • Disabling: 157 million days lost from work
  • Costly: $50 billion
  • Management of CGH is common within chiropractic
introduction1
Introduction
  • Evidence favors spinal manipulative therapy (SMT) for CGH, but is inconclusive
    • Evidence exists for reduction of CGH:
      • Intensity, frequency, and duration
  • Patient and SMT heterogeneity complicates previous findings
  • Unfortunately, the amount of treatment to obtain optimal outcomes has never been studied
    • Widely varied in research and practice
introduction2
Introduction
  • Haas decided to investigate the optimal treatment duration and frequency
  • Began investigating the dose-response of SMT for CGH with a small (n=24) feasibility study, published in ’04
    • Patients were allocated to 3, 12, or 16 visits over 3 weeks
    • Determined to be feasible to investigate the dose-response of SMT for the management of CGH
    • Preliminary data supported efficacy of 9-12 visits
purpose
Purpose
  • This article builds from the work from the previous feasibility study and investigates:
    • Dose: comparison of the effect of high dose (16 visits) vs. low dose (8 visits) of SMT for CGH pain intensity.
    • Efficacy: the relative efficacy of SMT for the care of CGH
      • Null hypothesis: no difference between SMT and

Light Massage (LM).

  • Do you think these are worthy objectives for a study?
methods
Methods
  • Pilot study
  • Randomized controlled trial
  • 80 participants
  • 2x2 Balanced Factorial design
  • Computer randomization was used to balance confounding baseline variables
  • Conducted at WSU and 3 Portland area private chiropractic clinics from 2004-07
methods1
Methods
  • 4 groups
  • All participants attended 16 visits over 8 weeks
    • Either 1x or 2x per week
      • Higher dose: 16 treatment visits
      • Lower dose: 8 treatments and 8 attention-control manual exams
  • All treatments lasted 10 minutes
interventions
Interventions
  • Providers: 4 DCs
  • SMT (therapeutic group):
    • 5 minutes of moist heat
    • 2 minutes of LM
    • Cervical and upper thoracic Diversified HVLA SMT
  • LM (control group):
    • 5 minutes of moist heat
    • 5 minutes of effleurage/pétrissage on neck and shoulders
1 outcome
1° Outcome
  • 1°: Modified Von Korff (MKV) pain intensity scale
      • CGH pain today, worst in past month, avg. last month
  • MCID = 20% of baseline pain
  • Powered to 80% (=0.05) to detect b/t group effect of 10 of 100 points
  • Not powered to detect interaction b/t intervention and dose.
  • Assessments performed each month for 6 months
2 outcomes
2° Outcomes
  • MKV Disability scale
      • ADLs, social/recreational activities, and housework ability
  • Number of CGH
  • Number of other headaches
  • Rx medication use
  • OTC medication use
  • Supplement/botanical use for headaches
  • All treated as secondary analysis at =0.05
statistical analysis
Statistical Analysis
  • Intention-to-treat analysis
  • Imputation for missing data
  • 1° outcome: Repeated Measures ANCOVA with GEEs
    • H0: means are the same at each time point
    • Adjusted group comparisons
    • Adjusted mean outcomes (AMD)
  • 2° outcomes: Multiple Logistic Regression
    • Outcome dichotomized to 50% improvement
questions or comments
Questions or comments
  • Advantages to the methods?
  • Limitations to the methods?
sample
Sample
  • Younger (36 yrs), Caucasian (85%), females (80%)
  • 86% of visits were completed
  • Mean MKV Pain: 54/100
  • Mean MKV Dysfunction: 45/100
  • Avg. 4 CGHs per wk.
  • Approximately 90% thought they could discern their CGH form other types of headache
results
Results
  • 1° outcome: MVK Pain scale
    • Dose: no clinically important effects
    • Efficacy: clinical important and significant effects between groups, favoring SMT over LM
    • Most improvement was achieved at 8 weeks of care
      • Effects lasted through the end of the study (6 months)
    • Slightly larger effects for higher dose (16 visits)
slide15

LM 16

LM 8

SMT 8

SMT 16

slide16

Results

  • 2° outcomes
    • MVK Disability scale
      • Favored SMT (similar to MKV Pain scale results)
    • CGH and “other” headache frequency
      • Effect favored SMT
    • Medication use
      • Favored SMT – 1/3 fewer medications at end of study
    • 50% improvement in MKV Pain scale
      • Favored SMT - Adjusted OR 3.0
slide17

LM 16

LM 8

SMT 16

SMT 8

discussion
Discussion
  • Dose:
    • Little difference between high and low dose
    • Somewhat larger effects with higher dose (16 visits), but did not reach MCID
  • Efficacy:
    • Clinically important and statistically significant differences favoring the SMT group for CGH pain and dysfunction
    • SMT reduced the number of CGHs by ½ at 8 weeks
    • SMT was 3 times more likely to produce a 50% reduction of CGH pain
slide19

Limitations

  • Pilot study, low sample size – preliminary results
  • Patients and clinicians were not masked
  • Prevalence of migraine was unexpectedly low (28%) for patients suffering from CGHs
  • Medication use of the sample may not be generalizable because potential participants taking preventative analgesics were excluded from participation
    • Necessary to minimize confounding
  • Follow-up was limited by grant support
conclusions
Conclusions
  • SMT is a viable option for the management of CGH
    • Pain
    • Headache frequency
  • Plateau in effects between 8 to 16 session
    • 12 week mark
  • Dose-response relationship remains unknown
  • Cost-effectiveness remains unknown
the next step
The next step…
  • NIH has awarded UWS $717,384 for Hass M, et al. to perform a follow-up study
  • Investigating the optimal dose of SMT for the management of CGH
    • Dose-response of SMT for CGH
    • Cost-effectiveness of care
  • 5-year multicenter randomized trial
  • 256 participants
  • Dose: 0, 6, 12, or 18 sessions for SMT or LM
  • 1° outcomes: CGH pain and number
your opinions
Your opinions…
  • Were any of the results surprising?
  • What do the preliminary results from this study suggest for clinicians?
  • What do these results suggest about dose-response?
  • What do these results suggest concerning safety?
  • Additional limitations of this study?