Chronic pain
Conditions
Interventions
in the second week, two clusters received the intervention and three did not
in the third week, three clusters received the intervention and two did not
in the fourth week, four clusters received the intervention and one did not
This is an open-label clinical trial with a stepped wedge randomization design. The intervention consisted of the application of Biokybernetik Smit, a complementary therapy of German origin developed
however, 40 individuals participated, divided into five groups of eight individuals each (clusters). In the first week, one cluster received the intervention (case) while four did not (control)
and in the fifth week, all five clusters received the intervention. The study concluded after the sixth week of intervention, although care sessions continued until all clusters had received six sessi
E02.190
Sponsors
Faculdade de Saúde Pública da USP
Faculdade de Saúde Pública da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age 18 years or older; of both sexes; complaint of musculoskeletal pain symptoms in any part of the body for more than 3 months
Exclusion criteria
Exclusion criteria: Age below 18 years; with no musculoskeletal pain for more than 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: An improvement in pain is expected, as measured by scores on the Brief Pain Inventory. ;Observed outcome 1: Regarding pain, a general improvement gradient was observed, with an average reduction of 18.8 points (out of a total of 110) in the Brief Pain Inventory (BPI) score per intervention (p < 0.05). In other words, each intervention led to an average decrease of 18.8 points in the BPI score. These effects remained significant after adjustment for confounding variables. An additional analysis by dimension showed an average reduction of 6.3 points (out of 40) in the pain intensity dimension per intervention (p < 0.05), and an average reduction of 12.53 points (out of 70) in the pain interference dimension per intervention (p < 0.05). ;Expected outcome 2: An improvement in quality of life is expected, as measured by the scores on the World Health Organization Quality of Life – BREF (WHOQOL-BREF).;Observed outcome 2: Regarding the effect of the intervention on quality of life, the analysis showed a general improvement gradient, with an average increase of 2.8 points in the overall WHOQOL-BREF score per intervention (p < 0.05). In other words, each intervention resulted in a 2.8-point increase in the overall WHOQOL-BREF score (p < 0.05). These effects were also observed after adjusting for confounding variables. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes were expected. | — |
Countries
Brazil
Contacts
Public ContactMariana Sato
Faculdade de Saúde Pública da Universidade de São Paulo
Outcome results
None listed