Physical Exam and Self-Reported Pain outcomes from a Randomized Trial on Chronic Cervicogenic Headache Darcy Vavrek ND MS 1 Mitch Haas DC MA 1 Dave Peterson

Physical Exam and Self-Reported Pain Physical Exam and Self-Reported Pain outcomes from a Randomized Trial on outcomes from a Randomized Trial on

Chronic Cervicogenic HeadacheChronic Cervicogenic Headache Darcy Vavrek ND MSDarcy Vavrek ND MS11

Mitch Haas DC MAMitch Haas DC MA11

Dave Peterson DCDave Peterson DC11

11Western States Chiropractic College, Portland Western States Chiropractic College, Portland OregonOregon

Funded by NCCAM NIH R21AT002324Funded by NCCAM NIH R21AT002324

SPARC – 2009 Western States Chiropractic College

Cervicogenic headache Cervicogenic headache (CHA)(CHA)

Cervicogenic headache (CHA) is a type of Cervicogenic headache (CHA) is a type of headache causally associated with headache causally associated with cervical myofascial tender spots cervical myofascial tender spots combined with cervical spine dysfunction. combined with cervical spine dysfunction.

((Headache Classification Subcommittee of the International Headache Society Headache Classification Subcommittee of the International Headache Society 2004) 2004)

The reported prevalence of CHA varies The reported prevalence of CHA varies from 13.8% to 17.8% of the headache from 13.8% to 17.8% of the headache population in different epidemiological population in different epidemiological studies.studies. (Anthony 2000, Nilsson 1995, Pfaffenrath 1990)(Anthony 2000, Nilsson 1995, Pfaffenrath 1990)


Spinal Manipulative Therapy Spinal Manipulative Therapy and CHAand CHA

The scientific evidence on SMT for the relief The scientific evidence on SMT for the relief of chronic headache has been well discussed of chronic headache has been well discussed in systematic reviews of randomized trials.in systematic reviews of randomized trials. (Hurwitz 1996, Vernon 1999, Bronfort 2001, Astin 2002, Bronfort 2004, (Hurwitz 1996, Vernon 1999, Bronfort 2001, Astin 2002, Bronfort 2004,

Lenssinck 2004, Fernandez-de-Las-Penas 2005 & 2006) Lenssinck 2004, Fernandez-de-Las-Penas 2005 & 2006)

These reviews looked at patient self-reported These reviews looked at patient self-reported outcomes when evaluating treatment effect outcomes when evaluating treatment effect such as pain intensity, headache index, such as pain intensity, headache index, frequency, duration, and improvement.frequency, duration, and improvement.

Missing were any objective outcomes that Missing were any objective outcomes that could be measured by the treating physician. could be measured by the treating physician.


Objectives of analysis Objectives of analysis projectproject

Headache pain studies use subject self-reported Headache pain studies use subject self-reported outcomes to assess treatment efficacy.outcomes to assess treatment efficacy.

Objective clinical measures for studies of CHA pain Objective clinical measures for studies of CHA pain have not been established.have not been established.

What do objective physical measures reveal and What do objective physical measures reveal and how do they associate with self-reported outcomes?how do they associate with self-reported outcomes?

In this analysis, we investigate relationships In this analysis, we investigate relationships between objective physical exam measures with between objective physical exam measures with self-reported CHA outcomes.self-reported CHA outcomes.

Associations between PE and self-reported Associations between PE and self-reported outcomes were evaluated using linear models, outcomes were evaluated using linear models, adjusting for socio-demographic differences and adjusting for socio-demographic differences and study group.study group.


The RCT that generated The RCT that generated the datathe data

This is a secondary analysis of an open-label This is a secondary analysis of an open-label randomized controlled pilot study with 80 randomized controlled pilot study with 80 subjects randomized to 8 or 16 treatments of subjects randomized to 8 or 16 treatments of spinal manipulative therapy or light massage spinal manipulative therapy or light massage control over 8 weeks. control over 8 weeks.

Forty of 80 subjects were randomized to 8 Forty of 80 subjects were randomized to 8 treatments (spinal manipulative therapy or light treatments (spinal manipulative therapy or light massage control) and 8 PE over 8 weeks. massage control) and 8 PE over 8 weeks.

Physical examinations by the study chiropractor Physical examinations by the study chiropractor served as an attention and physical contact served as an attention and physical contact control for the 40 subjects randomized to receive control for the 40 subjects randomized to receive care once a week for 8 weeks. care once a week for 8 weeks.

The remaining subjects received no follow-up PE. The remaining subjects received no follow-up PE.


Subjective outcomesSubjective outcomes

Self-reported outcomes included Self-reported outcomes included CHA and neck CHA and neck

PainPain Disability Disability

NeckNeck PainPain Disability Disability

Number of CHA headaches Number of CHA headaches Related CHA disability days Related CHA disability days


Physical Exam measuresPhysical Exam measures

Active cervical range of motion and Active cervical range of motion and associated painassociated pain

Motion palpation of the spineMotion palpation of the spine cervical regioncervical region upper thoracic regionupper thoracic region

Algometric pain threshold evaluated Algometric pain threshold evaluated over articular pillars/ transverse over articular pillars/ transverse processes processes


Baseline summaryBaseline summary Participants tended to be young (37 ± 11), Participants tended to be young (37 ± 11),

white, non-Hispanic (75%) women (78%). white, non-Hispanic (75%) women (78%). There were notable differences in race and There were notable differences in race and

smoking at baselinesmoking at baseline these will be used as covariates in the main analysisthese will be used as covariates in the main analysis

There were no differences between group There were no differences between group means in the subjective outcomesmeans in the subjective outcomes The mean CHA pain intensity and functional disability The mean CHA pain intensity and functional disability

were 54.0 and 48.3 respectively. were 54.0 and 48.3 respectively. The sample averaged approximately fifteen CHAs per The sample averaged approximately fifteen CHAs per

month month There were no clinically important differences There were no clinically important differences

between group means for physical exam between group means for physical exam outcomesoutcomes


Baseline summaryBaseline summary Participants tended to haveParticipants tended to have

cervical range of motion pain of 1.4 on a zero to ten pain cervical range of motion pain of 1.4 on a zero to ten pain scalescale

20o of restricted extension cervical range of motion20o of restricted extension cervical range of motion 4 total endplay restrictions of some kind4 total endplay restrictions of some kind pain pressure threshold of 3.2 kgpain pressure threshold of 3.2 kg pain score from orthopedic tests for midline pain of 0.7 on a pain score from orthopedic tests for midline pain of 0.7 on a

zero to ten pain scalezero to ten pain scale pain score of 1.1 across all ten point scale physical exam pain score of 1.1 across all ten point scale physical exam

pain measurespain measures Only two physical exam variables showed statistically Only two physical exam variables showed statistically

significant differences between group means after significant differences between group means after adjusting for smoking and raceadjusting for smoking and race sitting rotation endplay restriction for C6-7 to C7-T1 left and sitting rotation endplay restriction for C6-7 to C7-T1 left and

right (p=.034 and .028 respectively).right (p=.034 and .028 respectively).


Final outcome summaryFinal outcome summary While many physical exam measures showed a minor While many physical exam measures showed a minor

advantage of the SMT group over the LM group, on advantage of the SMT group over the LM group, on average, average,

there were only two PE measures whose mean treatment there were only two PE measures whose mean treatment group differences were statistically significant.group differences were statistically significant. Pain on Cervical ROM Right Rotation (mean difference 1.1, Pain on Cervical ROM Right Rotation (mean difference 1.1,

p=.025)p=.025) Pain on Cervical ROM Flexion (mean difference 1.1, p=.025)Pain on Cervical ROM Flexion (mean difference 1.1, p=.025) Both these measures favor SMT after adjusting for race, Both these measures favor SMT after adjusting for race,

smoking, and baseline physical exam measure.smoking, and baseline physical exam measure. Cervical ROM extension remains restricted in both Cervical ROM extension remains restricted in both

groups by about 20groups by about 20oo..


Final Outcome SummaryFinal Outcome Summary

Also, there are some differences Also, there are some differences noted in subjective outcome group noted in subjective outcome group means reported in our paper means reported in our paper submitted to Spine Journal.submitted to Spine Journal. (Haas – in review)(Haas – in review)

We decided to adjust for study We decided to adjust for study treatment group as well as smoking treatment group as well as smoking and race in our main analysis and race in our main analysis models.models.


Results of Main AnalysisResults of Main Analysis Cervical active ROM pain measures

were associated with neck pain intensity and disability, CHA frequency, and disability days at baseline.

Neck pain and disability were not measured at weeks 4 & 8 were no longer strongly associated at weeks 12 & 24

Cervical active ROM measures predicted CHA frequency and disability days well in the beginning, but this

faded over time. remained predictive of CHA frequency throughout study.

Sitting rotation endplay restriction was associated with CHA frequency and disability days at baseline and faded

over time. Pain Pressure Threshold (PPT)

was associated with CHA pain and disability, neck pain and disability, CHA frequency and disability days at week 12 and moderately associated in surrounding weeks.

Compression tests for midline pain were moderately associated with questionnaire outcomes with no clear pattern.

Distraction test associations were limited by the fact that all participants score zero on their distraction test

at their final physical exam.


DiscussionDiscussion

Physical exam measures of cervical Physical exam measures of cervical ROM pain and net cervical ROMROM pain and net cervical ROM were most associated with subjective were most associated with subjective

headache experience near baseline, headache experience near baseline, p<.001 to .038.p<.001 to .038.

Pain pressure thresholdsPain pressure thresholds were most associated with subjective were most associated with subjective

outcomes at/after week 12, p=.001 to .035.outcomes at/after week 12, p=.001 to .035. The pattern shifts at about week 12, The pattern shifts at about week 12,

four weeks after the final treatmentfour weeks after the final treatment


Cervical ROMCervical ROM Cervical ROM and pain on cervical ROM might be expected to be more Cervical ROM and pain on cervical ROM might be expected to be more

predictive for higher pain levels early on, since splinting may be an effect. predictive for higher pain levels early on, since splinting may be an effect. This association did not happen in all participants since, 11 out of 40 This association did not happen in all participants since, 11 out of 40

participants (~25%) reported no pain on cervical ROM at baseline. participants (~25%) reported no pain on cervical ROM at baseline. Yet those who had pain on cervical ROM also had worse subjective outcomes at Yet those who had pain on cervical ROM also had worse subjective outcomes at

baseline.baseline. Later on, with lower pain and some manual medicine related increased Later on, with lower pain and some manual medicine related increased

cervical ROM, cervical ROM and pain on cervical ROM would be expected cervical ROM, cervical ROM and pain on cervical ROM would be expected to have a lesser relationship. to have a lesser relationship.

However, with the improvement of most study participants, zero pain reported However, with the improvement of most study participants, zero pain reported on cervical ROM increased to 20 out of 40 participants (~50%) at their final on cervical ROM increased to 20 out of 40 participants (~50%) at their final physical examphysical exam

It is difficult to establish any type of linear relationship. It is difficult to establish any type of linear relationship. It is tempting to say that manipulation improved range of motion and the It is tempting to say that manipulation improved range of motion and the

pain associated with range of motion and decreased the subject’s pain associated with range of motion and decreased the subject’s headaches because manipulation is directed at improving joint mobility headaches because manipulation is directed at improving joint mobility and function. and function.

However, both treatment groups improved with time and we were not powered However, both treatment groups improved with time and we were not powered to detect this type of effect. to detect this type of effect.

Future studies that include cervical range of motion and associated pain as Future studies that include cervical range of motion and associated pain as baseline and final secondary outcomes in a study, measured by a blinded study baseline and final secondary outcomes in a study, measured by a blinded study physician, will allow clinicians to address these unanswered questions. physician, will allow clinicians to address these unanswered questions.


Pain Pressure ThresholdPain Pressure Threshold The fact that pain pressure threshold is not a good The fact that pain pressure threshold is not a good

baseline predictor of baseline subjective outcomes in baseline predictor of baseline subjective outcomes in our subject population is puzzling. our subject population is puzzling.

At 12 weeks, pressure over paraspinal soft tissues and At 12 weeks, pressure over paraspinal soft tissues and over the joints was perhaps more associated with over the joints was perhaps more associated with persistent headache outcomes because other persistent headache outcomes because other musculoskeletal components associated with the neck musculoskeletal components associated with the neck pain and headaches were not fully affected by thrust pain and headaches were not fully affected by thrust manipulation which potentially has more therapeutic manipulation which potentially has more therapeutic effect on joint mobility. effect on joint mobility.

Yet, we were underpowered to detect this type of result Yet, we were underpowered to detect this type of result and both treatment groups experienced this change in and both treatment groups experienced this change in association. association.

Still, for the practicing clinician, it is likely that those Still, for the practicing clinician, it is likely that those with a low pain pressure threshold may also have worse with a low pain pressure threshold may also have worse subjective experiences and thus be candidates for subjective experiences and thus be candidates for further manual care.further manual care.


No potential surrogates No potential surrogates notednoted

No one physical exam measure remained No one physical exam measure remained predictive of the self-reported headache predictive of the self-reported headache discomfort questions over time. discomfort questions over time.

This is likely due to patient improvement.This is likely due to patient improvement. Thus, no single objective physical exam Thus, no single objective physical exam

surrogate measure for CHA clinical surrogate measure for CHA clinical research is suggested by this study as a research is suggested by this study as a useful longitudinal outcome. useful longitudinal outcome.

Further analysis of the data will assess if Further analysis of the data will assess if these baseline physical exam measures these baseline physical exam measures are predictive of treatment outcome. are predictive of treatment outcome.


Cervical extensionCervical extension

Both groups remained restricted on Both groups remained restricted on cervical extension after treatment, cervical extension after treatment, 2020oo restriction on average. restriction on average.

Perhaps decreased cervical ROM on Perhaps decreased cervical ROM on extension is indicative of the extension is indicative of the population of those who might suffer population of those who might suffer from chronic cervicogenic from chronic cervicogenic headaches and could be a future headaches and could be a future focus of treatment assessment.focus of treatment assessment.


LimitationsLimitations BlindingBlinding

Treating physicians performing the attention Treating physicians performing the attention control physical exam control physical exam

were not blinded to treatment arm after baselinewere not blinded to treatment arm after baseline could have performed biased assessment could have performed biased assessment may have expected improvement based onmay have expected improvement based on

time in the studytime in the study treatment group assignment.treatment group assignment.

Small sample, 20 patients per treatment arm. Small sample, 20 patients per treatment arm. Minimal power to detect the associations we’ve Minimal power to detect the associations we’ve

looked forlooked for Results need to be repeated by larger studiesResults need to be repeated by larger studies

To further flush out the pathophysiology of cervicogenic To further flush out the pathophysiology of cervicogenic headache.headache.

Physical exam variables could be a secondary outcomePhysical exam variables could be a secondary outcome


LimitationsLimitations

GeneralizabilityGeneralizability Subjects Subjects

selected by rigid randomized clinical trial protocol selected by rigid randomized clinical trial protocol enrolled in the study went through enrolled in the study went through

a phone screena phone screen two baseline examstwo baseline exams had to meet study criteria before enrollmenthad to meet study criteria before enrollment

Larger clinical trials on headache Larger clinical trials on headache populations that gather longitudinal populations that gather longitudinal physical exam data will help to establish physical exam data will help to establish the generalizability of these results.the generalizability of these results.


ConclusionsConclusions

We noted that provocative cervical ROM pain was We noted that provocative cervical ROM pain was most predictive of the baseline headache experience. most predictive of the baseline headache experience.

However, 4 weeks after treatment, algometric pain However, 4 weeks after treatment, algometric pain thresholds were most predictive. thresholds were most predictive.

No one PE measure remained predictive of the self-No one PE measure remained predictive of the self-reported headache outcomes over time. reported headache outcomes over time.

Clinically important changes over time were Clinically important changes over time were observed in physical exam indicators for self-observed in physical exam indicators for self-reported CHA pain and disability outcomes. reported CHA pain and disability outcomes.

This is an important step towards establishing This is an important step towards establishing objective measures of CHA pain and disability for objective measures of CHA pain and disability for clinical studies.clinical studies.


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Physical Exam and Self-Reported Pain outcomes from a Randomized Trial on Chronic Cervicogenic Headache Darcy Vavrek ND MS 1 Mitch Haas DC MA 1 Dave Peterson