RESUMEN
OBJECTIVES: To compare the effects of acupuncture and medical training therapy in combination or individually with usual care on quality of life, depression, and anxiety in patients with tension-type headache. METHODS: In this single-center, prospective, randomized, controlled, unblinded trial, 96 adults (38.7(+/-13.3) years of age; 75 females/20 males/one dropout) with frequent episodic or chronic tension-type headache were randomized to one of four treatment groups (n = 24). The treatment groups received six weeks of either acupuncture or medical training therapy as monotherapies or in combination (12 interventions each), or usual care. We assessed depressiveness (PHQ-9), anxiety (GAD-7), and health-related quality of life (SF-12) as secondary outcome parameters at baseline, six weeks, three months, and six months after initiation of treatment. Linear mixed models were calculated. RESULTS: Both, acupuncture (baseline to six-weeks change scores: mean: -2(standard deviation: 2.5 points), three months: -2.4(2.4), six-months -2.7(3.6)) and the combination of acupuncture and medical training therapy (-2.7(4.9), -2.2(4.0), -2.2(4.2)) (each within-group p < .05) significantly reduced depressiveness-scores (PHQ-9) to a greater extent than medical training therapy (-0.3(2.0), -0.5(1.6), -0.9(2.6)) or usual care alone (-0.8(2.9), 0.1(2.8), 0.2(3.6)). We found similar results with anxiety scores and the physical sum scores of the SF-12. No severe adverse events occurred. CONCLUSIONS: Acupuncture and the combination of acupuncture and medical training therapy elicit positive effects on depression, anxiety, quality of life, and symptom intensity in patients with episodic and chronic tension-type headache. Acupuncture appears to play a central role in mediating the therapeutic effects, underscoring the clinical relevance of this treatment. An additive benefit of the combination of both therapies does not appear to be relevant.Trial registration: Registered on 11 February 2019. German Clinical Trials Register, DRKS00016723.
Asunto(s)
Terapia por Acupuntura , Cefalea de Tipo Tensional , Adulto , Femenino , Humanos , Masculino , Terapia por Acupuntura/métodos , Ansiedad/terapia , Depresión/terapia , Estudios Prospectivos , Calidad de Vida , Cefalea de Tipo Tensional/diagnóstico , Persona de Mediana EdadRESUMEN
Context ⢠Low-back pain (LBP) is a prevalent and potentially crippling condition for which treatment is often unsatisfactory from the perspectives of physicians, patients, and payers. The application of the fascial distortion model (FDM), an integrated concept for the diagnosis and manipulative treatment of musculoskeletal disorders, is conceptually promising for LBP but has not been investigated systematically. Objective ⢠The study intended to provide proof of concept to establish the noninferiority of the FDM treatment as opposed to the therapy recommended by the German National Disease Management Guideline (NDMG) for acute LBP. Design ⢠The study was a prospective, nonrandomized, controlled, parallel-group trial. Setting ⢠The study took place in a private practice for surgery and orthopedics. Participants ⢠Seventy-seven outpatients with acute LBP with an average age of 42.6 ± 13.5 y, 50.6% of whom were male, took part in the study. Intervention ⢠Participants in the intervention group (FDM group) received osteopathic manipulative treatments according to the FDM, whereas the control group (NDMG group) received an active control treatment following the NDMG. Outcome Measures ⢠Comparing the FDM group (n = 39) and the NDMG group (n = 38), the study measured pain (visual analog scale, patient diary), functional (FFbH-R) and self-reported vocational status, and use of medication (patient diary) at baseline and after 1, 4 and 12 wk of treatment. Results ⢠The study found marked improvements of the symptoms in both groups, with a faster onset of efficacy and significantly less medication under the FDM treatment. Conclusions ⢠FDM appears to be effective with regard to pain relief and functional improvement for LBP.