Dose-response and efficacy of spinal manipulation for care of cervicogenic headache: a dual-center randomized controlled trial

Abstract

Background Context The optimal number of visits for the care of cervicogenic headache (CGH) with spinal manipulative therapy (SMT) is unknown. Purpose To identify the dose-response relationship between visits for SMT and chronic CGH outcomes; to evaluate the efficacy of SMT by comparison with a light massage control. Study Design/Setting Two-site, open-label randomized controlled trial. Patient Sample Participants were 256 adults with chronic CGH. Outcome Measures The primary outcome was days with CGH in the prior 4 weeks evaluated at the 12- and 24-week primary endpoints. Secondary outcomes included CGH days at remaining endpoints, pain intensity, disability, perceived improvement, medication use, and patient satisfaction. Methods Participants were randomized to 4 dose levels of chiropractic SMT: 0, 6, 12, or 18 sessions. They were treated 3 times per week for 6 weeks and received a focused light-massage control at sessions when SMT was not assigned. Linear dose effects and comparisons to the no-manipulation control group were evaluated at 6, 12, 24, 39, and 52 weeks. This study was funded by the National Center for Complementary and Integrative Health (R01AT006330) and is registered at ClinicalTrials.gov (NCT01530321). The authors declare no conflicts of interest. Results A linear dose-response was observed for all follow-ups, a reduction of approximately 1 CGH day/4 weeks per additional 6 SMT visits (p<.05); a maximal effective dose could not be determined. CGH days/4 weeks were reduced from about 16 to 8 for the highest and most effective dose of 18 SMT visits. Mean differences in CGH days/4 weeks between 18 SMT visits and control were -3.3 (p=.004) and -2.9 (p=.017) at the primary endpoints, and similar in magnitude at the remaining endpoints (p<.05). Differences between other SMT doses and control were smaller in magnitude (p > .05). CGH intensity showed no important improvement nor differed by dose. Other secondary outcomes were generally supportive of the primary. Conclusion There was a linear dose-response relationship between SMT visits and days with CGH. For the highest and most effective dose of 18 SMT visits, CGH days were reduced by half, and about 3 more days per month than for the light-massage control.

Spinal manipulation for the management of cervicogenic headache: A systematic review and meta‐analysis

“…Three studies were from the United States (Dunning et al, 2016;Haas et al, 2018;Haas, Spegman, Peterson, Aickin, & Vavrek, 2010), two from Denmark (Nilsson, 1995;Nilsson & Christensen, 1997), one from Germany (Borusiak, Biedermann, Boßerhoff, & Opp, 2010) and one from Norway (Chaibi, Knackstedt, Tuchin, & Russell, 2017). Interventions were conducted in an independent chiropractic research institution in two studies (Nilsson, 1995;Nilsson et al, 1997), outpatient physical therapy clinics in one study (Dunning et al, 2016), chiropractic practices in one study (Chaibi et al, 2017), chiropractic college outpatient clinic in one study (Haas et al, 2010), university clinic and private chiropractic clinics in one study (Haas et al, 2018)and at a neuropediatric headache outpatient clinic in one study (Borusiak et al, 2010). SMT was delivered to the cervical spine (Borusiak et al, 2010;Chaibi et al, 2017;Dunning et al, 2016;Haas et al, 2010Haas et al, , 2018Nilsson, 1995;Nilsson et al, 1997), thoracic spine (Dunning et al, 2016;Haas et al, 2010Haas et al, , 2018 and ribs 1-9 (Dunning et al, 2016).…”

“…Interventions were conducted in an independent chiropractic research institution in two studies (Nilsson, 1995;Nilsson et al, 1997), outpatient physical therapy clinics in one study (Dunning et al, 2016), chiropractic practices in one study (Chaibi et al, 2017), chiropractic college outpatient clinic in one study (Haas et al, 2010), university clinic and private chiropractic clinics in one study (Haas et al, 2018)and at a neuropediatric headache outpatient clinic in one study (Borusiak et al, 2010). SMT was delivered to the cervical spine (Borusiak et al, 2010;Chaibi et al, 2017;Dunning et al, 2016;Haas et al, 2010Haas et al, , 2018Nilsson, 1995;Nilsson et al, 1997), thoracic spine (Dunning et al, 2016;Haas et al, 2010Haas et al, , 2018 and ribs 1-9 (Dunning et al, 2016). Other manual therapy interventions were heterogeneous in nature and included: spinal mobilization and cranio-cervical flexion exercises (Dunning et al, 2016), light massage (Haas et al, 2010(Haas et al, , 2018 and deep friction massage with laser (Nilsson, 1995;Nilsson et al, 1997).…”

“…SMT was delivered to the cervical spine (Borusiak et al, 2010;Chaibi et al, 2017;Dunning et al, 2016;Haas et al, 2010Haas et al, , 2018Nilsson, 1995;Nilsson et al, 1997), thoracic spine (Dunning et al, 2016;Haas et al, 2010Haas et al, , 2018 and ribs 1-9 (Dunning et al, 2016). Other manual therapy interventions were heterogeneous in nature and included: spinal mobilization and cranio-cervical flexion exercises (Dunning et al, 2016), light massage (Haas et al, 2010(Haas et al, , 2018 and deep friction massage with laser (Nilsson, 1995;Nilsson et al, 1997). Additionally, light touch to specific cervical spine segments (Borusiak et al, 2010) and manipulation at the lateral edge of the scapula and/or the gluteal region (Chaibi et al, 2017) were, respectively, considered as sham interventions, and incorporated into other manual therapies.…”

“…Numerous outcome measures were utilized for pain intensity including Visual Analogue Scale (VAS) (Nilsson, 1995;Nilsson et al, 1997), the Modified Von Korff Scale (Haas et al, 2010), Numerical Rating Scale (NRS) (Chaibi et al, 2017;Haas et al, 2018), Numeric Pain Rating Scale (NPRS) (Dunning et al, 2016) and the Visual/Numerous Analog Scale (VAS/NAS) (Borusiak et al, 2010). For disability; the Modified Von Korff Scale (Haas et al, 2010), Neck Disability Index (NDI) (Dunning et al, 2016) and the Headache Impact test (HIT-6) were utilized (Haas et al, 2018). For pain frequency; mean of 30 days/month (Chaibi et al, 2017), mean days with headache in the last 4 weeks (Haas et al, 2010(Haas et al, , 2018 and headache days in the week (Dunning et al, 2016) were used.…”

Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years. A randomised clinical trial

“…Spinal manipulation is not uncommon for children with headache, as it is the presenting symptom for 11-20% of school-aged children and adolescents in chiropractic practice (18)(19)(20). Nevertheless, with the exception of one small study where the children only received a single manipulative treatment (21), which is not common practice (16,22), there has not been any formal investigation into the effectiveness of spinal manipulation for children with recurrent headache.…”