Does a Prolonged Sham Theta Burst Stimulation Intervention Regimen Outperform Standard Care in Terms of Functional Recovery and Pain Relief After an Upper Limb Fracture?

Abstract

Objective: In a recent sham-controlled 13-session prolonged continuous theta burst stimulation intervention protocol, recovery from upper limb fracture at both 1 and 3 months was better than anticipated in patients assigned to the sham intervention group. To determine whether potential placebo effect and close patient monitoring affected recovery, the current study aimed to compare clinical outcomes between sham-treated participants who also received standard care with similarly injured patients who only received standard care.

Methods: Twenty participants with isolated upper limb fractures from the sham group were seen 13 times post-fracture (1 baseline session, 10 treatments, and 2 follow-ups [1 and 3 months]) over 3 months. They completed the self-reported Disabilities of Arm, Shoulder, and Hand (DASH) questionnaire and the Numerical Rating Scale for pain assessment at 1 and 3 months post-fracture. Two control groups were recruited: 43 participants at 1 month post-fracture and another 40 participants at 3 months post-fracture. These control groups completed the same questionnaires online, without any lab visits.

Results: At 1 month, patients from the sham group reported significantly less functional impairments on the DASH (p = .010). At 3 months, significantly more patients from the control group reported functional limitations (72.5% versus sham's 40%, p = .015).

Conclusions: Although preliminary, these findings suggest clinically significant beneficial effects of the sham intervention over the standard care groups. This positive sham intervention effect may be attributed to a placebo response that includes the placebo effect associated with sham rTMS, but also the impact of various factors such as the close monitoring of the injury.