Original Article
Dose Response for Chiropractic Care of Chronic Cervicogenic Headache and Associated Neck Pain: A Randomized Pilot Study

https://doi.org/10.1016/j.jmpt.2004.10.007Get rights and content

Objective

To acquire information for designing a large clinical trial and determining its feasibility and to make preliminary estimates of the relationship between headache outcomes and the number of visits to a chiropractor.

Design

Randomized, controlled trial.

Setting

Private practice in a college outpatient clinic and in the community.

Subjects

Twenty-four adults with chronic cervicogenic headache.

Methods

Patients were randomly allocated to 1, 3, or 4 visits per week for 3 weeks. All patients received high-velocity low-amplitude spinal manipulation. Doctor of Chiropractics could apply up to 2 physical modalities at each visit from among heat and soft tissue therapy. They could also recommend modification of daily activities and rehabilitative exercises. Outcomes included 100-point Modified Von Korff pain and disability scales, and headaches in last 4 weeks.

Results

Only 1 participant was insufficiently compliant with treatment (3 of 12 visits), and 1 patient was lost to follow-up. There was substantial benefit in pain relief for 9 and 12 treatments compared with 3 visits. At 4 weeks, the advantage was 13.8 (P = .135) for 3 visits per week and 18.7 (P = .041) for 4 visits per week. At the 12-week follow-up, the advantage was 19.4 (P = .035) for 3 visits per week and 18.1 (P = .048) for 4 visits per week.

Conclusion

A large clinical trial on the relationship between pain relief and the number of chiropractic treatments is feasible. Findings give preliminary support for the benefit of larger doses, 9 to 12 treatments, of chiropractic care for the treatment of cervicogenic headache.

Section snippets

Design

This study was a prospective, randomized, controlled trial (Fig 1). Twenty-four participants were randomized to 1 of 3 treatment groups by using an equal allocation algorithm (n = 8 per group). Design adaptive randomization was used to balance potential predictors of outcomes across groups (baseline HA pain and disability, neck pain and disability, and treating chiropractor).21., 22. Group allocation was concealed before randomization; data required by the allocation program were entered at the

Results

The staff conducted 86 phone screens (Fig 1). Of these, 57 were ineligible or not interested. The study chiropractors conducted 29 screening physical examinations. Four were ineligible and 1 was a no show. Twenty-four participants were randomized over 8 months. The typical participant was a white woman, age 40, with a college degree (Table 1). The total sample mean scores were: HA pain, 52.6 (SD = 17.4); HA disability, 37.7 (SD = 23.5); number of HA, 16.6 (SD = 8.7); neck pain, 56.3 (SD =

Discussion

Our pilot study showed the feasibility of a larger randomized trial. Participants were willing to be randomized, follow the treatment protocol, and complete the baseline and mail follow-up questionnaires. Only 1 person dropped out of the study because of disappointment that treatment visits were not an hour long. Noncompliance with the treatment schedule was minimal (1 person). Perhaps the success with these feasibility criteria can be attributed to 3 design strategies. We included 2 baseline

Conclusion

A large clinical trial on the relationship between cervicogenic HA outcomes and treatments from a chiropractor is feasible. Findings suggest the benefit of 9 to 12 visits over 3 weeks for the treatment of HA/neck pain and disability. A larger number of visits than 12 in 3 weeks may be required for maximum relief and durability of outcomes.

Acknowledgment

The authors thank David Corll, DC, for serving as the clinician for this study.

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    Funded by a grant from The Oregon Craniofacial Complementary and Alternative Medicine Center, National Center for Complementary and Alternative Medicine/National Institutes of Health (under P50 AT00076).

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