Jennifer M. Dexheimer

Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Pilot Study

OBJECTIVES The purpose of this pilot study was to investigate the feasibility of a randomized clinical trial of shoe orthotics for chronic low back pain. METHODS The study recruited 50 patients with chronic low back pain through media advertising in a midwestern suburban area. Medical history and a low back examination were completed at a chiropractic clinic. Subjects were randomized to either a treatment group receiving custom-made shoe orthotics or a wait-list control group. After 6 weeks, the wait-list control group also received custom-made orthotics. This study measured change in perceived pain levels (Visual Analog Scale) and functional health status (Oswestry Disability Index) in patients with chronic low back pain at the end of 6 weeks of orthotic treatment compared with no treatment and at the end of 12 weeks of orthotic treatment. RESULTS This study showed changes in back pain and disability with the use of shoe orthotics for 6 weeks compared with a wait-list control group. It appears that improvement was maintained through the 12-week visit, but the subjects did not continue to improve during this time. CONCLUSIONS This pilot study showed that the measurement of shoe orthotics to reduce low back pain and discomfort after 6 weeks of use is feasible. A larger clinical trial is needed to verify these results.

Quantification of cavitation and gapping of lumbar zygapophyseal joints during spinal manipulative therapy

OBJECTIVES The purpose of this study was to use previously validated methods to quantify and relate 2 phenomena associated with chiropractic spinal manipulative therapy (SMT): (1) cavitation and (2) the simultaneous gapping (separation) of the lumbar zygapophyseal (Z) joint spaces. METHODS This was a randomized, controlled, mechanistic clinical trial with blinding. Forty healthy participants (18-30 years old) without a history of low-back pain participated. Seven accelerometers were affixed to the skin overlying the spinous processes of L1 to L5 and the S1 and S2 sacral tubercles. Two additional accelerometers were positioned 3 cm left and right lateral to the L4/L5 interspinous space. Participants were randomized into group 1, side-posture SMT (n = 30), or group 2, side-posture positioning (SPP, n = 10). Cavitations were determined by accelerometer recordings during SMT and SPP (left side = upside for both groups); gapping (gapping difference) was determined by the difference between pre- and postintervention magnetic resonance imaging scan joint space measurements. Results of mean gapping differences were compared. RESULTS Upside SMT and SPP joints gapped more than downside joints (0.69 vs -0.17 mm, P < .0001). Spinal manipulative therapy upside joints gapped more than SPP upside joints (0.75 vs 0.52 mm, P = .03). Spinal manipulative therapy upside joints gapped more in men than in women (1.01 vs 0.49 mm, P < .002). Overall, joints that cavitated gapped more than those that did not (0.56 vs 0.22 mm, P = .01). No relationship was found between the occurrence of cavitation and gapping with upside joints alone (P = .43). CONCLUSIONS Zygapophyseal joints receiving chiropractic SMT gapped more than those receiving SPP alone; Z joints of men gapped more than those of women, and cavitation indicated that a joint had gapped but not how much a joint had gapped.

A Pilot Randomized Controlled Trial of Flexion-Distraction Dosage for Chiropractic Treatment of Lumbar Spinal Stenosis

OBJECTIVE The purpose of this pilot clinical trial was to assess the feasibility of recruiting older adults with lumbar spinal stenosis (LSS) into a clinical trial that used different dosages of flexion-distraction manipulation. METHODS This randomized controlled trial used a 4-group design. Three groups consisted of chiropractic flexion-distraction manipulation applied at different dosages (8, 12, or 18 treatments). The fourth group was given 8 treatments of placebo care. Feasibility measures included recruitment goals, adherence to various treatment schedules, credibility of the placebo treatment, and rates of adverse events. The primary outcome measure was the Swiss Spinal Stenosis Questionnaire, a validated self-report of LSS symptom severity and physical function. RESULTS The recruitment and adherence goals of the study were met with a total of 60 subjects randomized (n = 15 per group) and most subjects attending at least 75% of their scheduled visits. No adverse events were reported by any of the subjects in the trial. Our placebo treatment did not appear to be credible; most subjects correctly guessed that they were receiving a placebo treatment. Between-group effect size estimates were small, indicating larger samples are needed for future studies. CONCLUSION This pilot study showed that it is feasible to recruit patients with LSS and that most subjects will adhere to a 6-week treatment schedule. The information gained from this trial will be useful to inform the design of larger trials.

Recruitment Methods and Costs for a Randomized, Placebo-Controlled Trial of Chiropractic Care for Lumbar Spinal Stenosis: A Single-Site Pilot Study

OBJECTIVE The purpose of this article is to describe the methods for recruitment in a clinical trial on chiropractic care for lumbar spinal stenosis. METHODS This randomized, placebo-controlled pilot study investigated the efficacy of different amounts of total treatment dosage over 6 weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects were recruited for this study through several media venues, focusing on successful and cost-effective strategies. Included in our efforts were radio advertising, newspaper advertising, direct mail, and various other low-cost initiatives. RESULTS Of the 1211 telephone screens, 60 responders (5.0%) were randomized into the study. The most successful recruitment method was radio advertising, generating more than 64% of the calls (776 subjects). Newspaper and magazine advertising generated approximately 9% of all calls (108 subjects), and direct mail generated less than 7% (79 subjects). The total direct cost for recruitment was

Distribution of Cavitations as Identified with Accelerometry During Lumbar Spinal Manipulation

40 740 or

Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial

679 per randomized patient. The costs per randomization were highest for direct mail (

Advancing health promotion through massage therapy practice: A cross-sectional survey study

995 per randomization) and lowest for newspaper/magazine advertising (

Changes in Blood Pressure After Various Forms of Therapeutic Massage: A Preliminary Study

558 per randomization). CONCLUSIONS Success of recruitment methods may vary based on target population and location. Planning of recruitment efforts is essential to the success of any clinical trial.

Side-effects of massage therapy: A cross-sectional study of 100 clients

OBJECTIVE This project determined the location and distribution of cavitations (producing vibrations and audible sounds) in the lumbar zygapophyseal (Z) joints that were targeted by spinal manipulative therapy (SMT). METHODS This randomized, controlled, clinical study assessed 40 healthy subjects (20 men, 20 women) 18 to 30 years of age who were block randomized into SMT (group 1, n = 30) or side-posture positioning only (group 2; control, n = 10) groups. Nine accelerometers were placed on each patient (7 on spinous processes/sacral tubercles of L1-S2 and 2 placed 3 cm left and right lateral to the L4/L5 interspinous space). Accelerometer recordings were made during side-posture positioning (groups 1 and 2) and SMT (group 1 only). The SMT was delivered by a chiropractic physician with 19 years of practice experience and included 2 high-velocity, low-amplitude thrusts delivered in rapid succession. Comparisons using χ(2) or McNemar test were made between number of joints cavitating from group 1 vs group 2, upside (contact side for SMT) vs downside, and Z joints within the target area (L3/L4, L4L5, L5/S1) vs outside the target area (L1/L2, L2/L3, sacroiliac). RESULTS Fifty-six cavitations were recorded from 46 joints of 40 subjects. Eight joints cavitated more than once. Group 1 joints cavitated more than group 2 joints (P < .0001), upside joints cavitated more than downside joints (P < .0001), and joints inside the target area cavitated more than those outside the target area (P < .01). CONCLUSIONS Most cavitations (93.5%) occurred on the upside of SMT subjects in segments within the target area (71.7%). As expected, SMT subjects cavitated more frequently than did subjects with side-posture positioning only (96.7% vs 30%). Multiple cavitations from the same Z joints had not been previously reported.

Magnetic Resonance Imaging Zygapophyseal Joint Space Changes (Gapping) in Low Back Pain Patients following Spinal Manipulation and Side Posture Positioning: A Randomized Controlled Mechanisms Trial with Blinding

OBJECTIVES To investigate the efficacy of shoe orthotics with and without chiropractic treatment for chronic low back pain compared with no treatment. DESIGN Randomized controlled trial. SETTING Integrative medicine teaching clinic at a university. PARTICIPANTS Adult subjects (N=225) with symptomatic low back pain of ≥3 months were recruited from a volunteer sample. INTERVENTIONS Subjects were randomized into 1 of 3 treatment groups (shoe orthotic, plus, and waitlist groups). The shoe orthotic group received custom-made shoe orthotics. The plus group received custom-made orthotics plus chiropractic manipulation, hot or cold packs, and manual soft tissue massage. The waitlist group received no care. MAIN OUTCOME MEASURES The primary outcome measures were change in perceived back pain (numerical pain rating scale) and functional health status (Oswestry Disability Index) after 6 weeks of study participation. Outcomes were also assessed after 12 weeks and then after an additional 3, 6, and 12 months. RESULTS After 6 weeks, all 3 groups demonstrated significant within-group improvement in average back pain, but only the shoe orthotic and plus groups had significant within-group improvement in function. When compared with the waitlist group, the shoe orthotic group demonstrated significantly greater improvements in pain (P<.0001) and function (P=.0068). The addition of chiropractic to orthotics treatment demonstrated significantly greater improvements in function (P=.0278) when compared with orthotics alone, but no significant difference in pain (P=.3431). Group differences at 12 weeks and later were not significant. CONCLUSIONS Six weeks of prescription shoe orthotics significantly improved back pain and dysfunction compared with no treatment. The addition of chiropractic care led to higher improvements in function.