Pilot Study of Spinal Manipulation for Chronic Neck Pain
Pilot Study of Spinal Manipulation for Chronic Neck Pain
This study is designed to determine whether a medicine that can produce temporary amnesia
 (midazolam) can be used to block the memory of treatment with spinal manipulation. This is
 important since any study that is designed to determine whether spinal manipulation is
 effective would be better if patients were not aware of whether or not they were treated.
 This would allow a true assessment of treatment effects without the complication of a strong
 placebo effect that manipulative treatment may produce.
There has been growing recognition of the high frequency with which Americans utilize
 complementary and alternative health care providers and that annually about 10% of the
 population is treated by a chiropractor. While chiropractors employ several types of
 treatment, spinal manipulation is the most important and unique of these therapies. Over 90%
 of the spinal manipulations performed in the U.S. are done by chiropractors with most of the
 remainder performed by osteopathic physicians. The annual number of chiropractic visits in
 the U.S. has been estimated at approximately 100 per 100 person-years.

 Spinal manipulation and chiropractic have been controversial at least partially due to a
 paucity of clinical scientific evidence of benefit. For example, reviews of the literature on
 randomized clinical trials (RCT's) of manipulative treatment for back pain have variably
 found evidence of benefit or insufficient evidence of benefit. A review of the existing
 clinical trials of spinal manipulation for neck pain concluded that most of the five existing
 RCT's were of relatively poor quality and that, despite some evidence for very short-term
 benefit, studies of higher quality will be needed in order to determine whether there is
 clinical benefit for this condition. This issue is important since neck pain is the second
 most common reason for presentation to chiropractors.

 There are several difficulties in researching the effects of spinal manipulation. Most of the
 conditions that are treated (i.e., back and neck pain) do not have a well-defined
 pathophysiology. Therefore, it is not possible to study treatment by evaluating the effects
 of treatment on physiological variables. The lack of a proven pathophysiology also leads to
 heterogeneous study populations with large variability in response to treatment. This makes
 it necessary to use large experimental populations in order to detect any effects of
 treatment. There is heavy reliance on subjective outcome measures in neck and back pain
 research, making these clinical trials particularly sensitive to placebo or "nonspecific"
 effects. The use of blinded subjects is the accepted method of dealing with these issues, but
 blinding is particularly difficult to achieve when investigating physical interventions,
 particularly those where the therapist can't be blinded as to whether s/he is delivering an
 actual or sham treatment.

 The present proposal is in response to a request for applications for pilot studies to
 establish the methodological feasibility and strengthen the scientific rationale for
 proceeding to full-scale RCTs on the use of chiropractic or osteopathy to manage or treat
 musculoskeletal injuries and disorders. One of the stated goals of this request for
 applications is to refine the control strategy for studies of manipulative therapy. The
 proposed study will examine whether an amnestic agent, midazolam, can be used to blind
 subjects to their experimental group in a double-blind, pilot RCT. This proposal is similar
 to a study by Sloop et al who used diazepam to produce amnesia in a study of spinal
 manipulation for chronic neck pain. The present study will utilize an agent with more
 specific amnestic effects and will also address several methodological problems with their
 study. If successful, the methods employed in this pilot study may permit a high degree of
 blinding in full scale RCT's of spinal manipulation.
This study will enroll patients with chronic neck pain (more than 3 months duration) with
 or without occipitally-based head pain and without signs of radiculopathy or myelopathy.
 They must have pain of at least moderate intensity (by their report and by a score of at
 least 3 out of 10 on a visual analogue pain scale) on at least four days out of a week and
 have had some limitations of activity on a weekly basis due to their neck pain. These
 subjects should not have had spinal manipulative treatment for at least two years and
 should not have had any adverse reactions to manipulative treatment or to benzodiazepines.
 They may not be regular users of benzodiazepine medications. They also should not be
 currently enrolled in an ongoing physical therapy program, though they may be taking
 analgesics, anti-inflammatories or other medications for their problem. They may continue
 with any ongoing exercise program. Subjects will also be excluded if they are pregnant,
 lactating or plan to be pregnant, if they have significant cardiac or pulmonary disease or
 if they plan on relocating during the course of the study. The subjects will also be
 evaluated by a trained and experienced manipulative practitioner (see below) for the
 presence of lesions which would be amenable to manipulation and by a medical physician for
 the absence of any contraindications to manipulative treatments.