Effectiveness of spinal manipulation in addition to pharmacological treatment in fibromyalgia: A blinded randomized trial

Abstract

Background It has been suggested that spinal manipulation may alter sensorimotor integration in the central nervous system and therefore may be used to treat central sensitization syndromes. Objective To investigate the effectiveness of spinal manipulation in addition to pharmacological treatment in patients with fibromyalgia. Design A single‐center, randomized, and placebo‐controlled trial with three parallel arms Setting Outpatient clinics at a tertiary health care facility. Participants Female patients aged 18‐55 years receiving pharmacological treatment. Interventions Spinal manipulation, sham manipulation, and control groups. Patients in the spinal manipulation group received high‐velocity low‐amplitude manipulation treatment twice a week for 3 weeks. Patients in the sham group received an application that was very similar to the active treatment but was not expected to have any real therapeutic effect. Patients in the control group continued to receive pharmacological therapy. Main Outcome Measures The primary outcome, pain score (visual analog scale), and secondary outcomes, pressure pain threshold (PPT), Revised Fibromyalgia Impact Questionnaire (FIQR), Widespread Pain Index (WPI), and Fibromyalgia Severity Score (FSS) were measured before, 1 month, and 3 months after randomization. Results Sixty patients with a mean age of 41.7 years (SD = 8.0) were enrolled in the study. A mixed‐design repeated analysis of covariance was used to test the data. At 1 month after randomization, pain scores did not differ between groups. At 3 months after randomization, the spinal manipulation group had a significantly lower pain score (adjusted mean = 4.3 cm, SE: 0.4) than the control group (adjusted mean = 6.8 cm, SE: 0.4) and the sham manipulation group (adjusted mean = 5.7 cm, SE: 0.4). PPT did not differ between groups at any time point. FIQR, WPI, and FSS showed some improvement 1 or 3 months after randomization in favor of the spinal manipulation group. Conclusions Spinal manipulation used in addition to pharmacological treatment in young/middle‐aged female patients with fibromyalgia could be an effective treatment for pain, disease severity, and functionality.

Placebo analgesia in physical and psychological interventions: Systematic review and meta‐analysis of three‐armed trials

“… c Ince et al. (2023) recruited only patients who were taking medication for fibromyalgia, but drug regimens did not change significantly during the study. …”

“…Most trials investigated manual therapy interventions ( n = 10, 59%) (Bialosky et al., 2014; Cerritelli et al., 2015; Chaibi et al., 2017; Hasuo et al., 2022; Hensel et al., 2015; Ince et al., 2023; Licciardone et al., 2010; Moraska et al., 2017; Ozgul et al., 2023; Paulo et al., 2021), followed by mindfulness and other relaxation interventions ( n = 3, 18%) (Amirova et al., 2017; Loose et al., 2021; Schmidt et al., 2011). One trial each investigated pain self‐management programmes (Allen et al., 2010), cognitive‐behavioural therapy (Ashar et al., 2022), exercises (Krauß et al., 2014) and Reiki (Sisman & Arslan, 2022).…”

“…Detuned ultrasound devices were used in five cases (31%), controlling for manual therapy interventions (Hensel et al., 2015; Licciardone et al., 2010; Moraska et al., 2017; Ozgul et al., 2023) or exercise (Krauß et al., 2014). Manual control interventions were also used five times; in the form of simulated manoeuvres (Bialosky et al., 2014; Chaibi et al., 2017; Hasuo et al., 2022; Ince et al., 2023), controlling mainly for spinal manipulation therapy, or soft touch application controlling for craniosacral therapy (Cerritelli et al., 2015). The remaining control interventions classed as ‘other’ included educational attention controls used in a pain self‐management trial (Allen et al., 2010), open‐label saline injection in a cognitive‐behavioural trial (Ashar et al., 2022), patient positioning on a treatment bench without further manipulation, used in a myofascial release study (Paulo et al., 2021) and simulated hands‐off Reiki (Sisman & Arslan, 2022).…”

“…Participants were reported as supposed to be blinded to group allocation in nine control intervention arms (53%) (Amirova et al., 2017; Bialosky et al., 2014; Cerritelli et al., 2015; Chaibi et al., 2017; Ince et al., 2023; Loose et al., 2021; Moraska et al., 2017; Schmidt et al., 2011; Sisman & Arslan, 2022). Blinding was not an objective in five control intervention arms (29%) (Ashar et al., 2022; Hasuo et al., 2022; Krauß et al., 2014; Ozgul et al., 2023; Paulo et al., 2021), one of which only blinded participants to another active comparator, not the main investigational treatment (Krauß et al., 2014).…”

“…Other (educational attention control, simulated hands-off manoeuvre, multicomponent therapist interaction, mimicked patient body positioning, floatation tank with altered settings, white noise and saline injection)Ince et al (2023) recruited only patients who were taking medication for fibromyalgia, but drug regimens did not change significantly during the study.…”