A randomized control trial to determine the effectiveness and physiological effects of spinal manipulation and spinal mobilization compared to each other and a sham condition in patients with chronic low back pain: Study protocol for The RELIEF Study

Abstract

Background: Low back pain (LBP) is one of the most common reasons for seeking medical care. Manipulative therapies are a common treatment for LBP. Few studies have compared the effectiveness of different types of manipulative therapies. Moreover, the physiologic mechanisms underlying these treatments are not fully understood. Herein, we present the study protocol for The Researching the Effectiveness of Lumbar Interventions for Enhancing Function Study (The RELIEF Study).

Methods and study design: The RELIEF Study is a Phase II RCT with a nested mechanistic design. It is a single-blinded, sham-controlled study to test the mechanisms and effectiveness of two manual therapy techniques applied to individuals (n = 162; 18-45 years of age) with chronic LBP. The clinical outcome data from the mechanistic component will be pooled across experiments to permit an exploratory Phase II RCT investigating the effectiveness. Participants will be randomized into one of three separate experiments that constitute the mechanistic component to determine the muscular, spinal, and cortical effects of manual therapies. Within each of these experimental groups study participants will be randomly assigned to one of the three treatment arms: 1) spinal manipulation, 2) spinal mobilization, or 3) sham laser therapy. Treatments will be delivered twice per week for 3-weeks.

Discussion: This data from this will shed light on the mechanisms underlying popular treatments for LBP. Additionally, the coupling of this basic science work in the context of a clinical trial will also permit examination of the clinical efficacy of two different types of manipulative therapies.

Trial registration: ClinicalTrials.gov NCT01854892.

Keywords: Low back pain; Manual therapies; Mobilization; Muscle energy; Spinal manipulation.

Figure 1

Two neural pathways suggested to form the basis of a pain-spasm-pain cycle. Left side: Nociceptive afferents (N) transmit feedback via excitatory interneurons (E) to the alpha motor neurons (α) that cause increased muscle activation (spasm). Right side: Nociceptive afferents (N) provide excitatory input on the gamma motor neurons (γ) that increase the sensitivity of the muscle spindles (s), which activate alpha motoneurons via excitatory interneurons (E) further increasing muscle activation and pain. From Van Dien et al., J Electromyography Kinesiol, 2003.

Figure 2

Detailed overview of study protocol.