An Additive Effect of Instrument-Assisted Soft Tissue Mobilization with Spinal Manipulation in Cervicogenic Headache: a Randomized Controlled Trial.

Introduction: There is a multitude of evidence supporting the use of manual and manipulative therapy techniques for patients with cervicogenic headache (CGH). However, evidence in finding and comparing the efficacy of instrument assisted soft tissue mobilization with manual therapy in unilateral cervicogenic headache is lacking. Therefore, the objective of the study is to find and compare the long term effects of instrument assisted soft tissue mobilization along with spinal manipulation therapy in patients with cervicogenic headache.

Methods: It is a randomized, single-blinded controlled study conducted at University hospital. Overall, 64 participants with CGH were divided into spinal manipulation therapy group (SMT; n = 32) and spinal manipulation therapy with instrument assisted soft tissue mobilization (ISM) group (SMT + ISM; n = 32) and they received the respective treatment for 4 weeks. In addition, both groups received 10 min of heat therapy and neck isometric exercises three times a day. The primary (CGH frequency) and secondary (CGH pain intensity, CGH disability neck pain frequency, pain intensity, pain threshold, neck disability index and quality of life) scores were measured at baseline, after 4 weeks, and at 6 months.

Results: The reports of the SMT and SMT + ISM group were compared. Following 4 weeks of training, and at 6 months follow up the SMT + ISM group showed more significant changes in the primary outcome (CGH frequency) with a -4.3 [(95% confidence interval (CI) -4.80 to -3.79] and -1.7 (95% CI -1.92 to -1.47), when compared with the SMT group alone (p = 0.001). The secondary outcomes (CGH pain intensity, CGH disability, neck pain frequency, neck pain intensity, neck disability index, and quality of life) also shows more significant changes in the SMT + ISM group than the SMT group (p = 0.001). The same gradual improvement can be seen in the above variables at 6 months follow up. At the same time, neck pain threshold level does not show any improvement at 4 weeks (p ≥ 0.05) but shows a statistical difference at 6 months follow up. No such adverse effects or consequences were noted during or after the intervention.

Conclusions: The study concluded that spinal manipulation therapy with instrument assisted soft tissue mobilization provided better long-term outcomes in patients with cervicogenic headache. This study provided a piece of sound physical therapy evidence for a widespread and costly clinical condition, such as cervicogenic headache.

Clinical trial registration: The trial was registered prospectively in the Indian clinical trial registry with CTRI/2020/06/026243 on 30/06/2020.