A New Approach to Assess Blinding for Transcranial Direct Current Stimulation Treatment in Patients with Fibromyalgia. A Randomized Clinical Trial
Correct blinding is essential for preventing potential biases. The aim of this study was to assess the blinding of participants and a therapist following treatment with transcranial direct current stimulation in subjects with fibromyalgia using James’ and Bang’s blinding indexes. Eighty subjects wer...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2021-10-01
|
| Series: | Brain Sciences |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-3425/11/10/1335 |
| _version_ | 1797515124711358464 |
|---|---|
| author | Rubén Arroyo-Fernández Juan Avendaño-Coy Rafael Velasco-Velasco Rocío Palomo-Carrión Elisabeth Bravo-Esteban Asunción Ferri-Morales |
| author_facet | Rubén Arroyo-Fernández Juan Avendaño-Coy Rafael Velasco-Velasco Rocío Palomo-Carrión Elisabeth Bravo-Esteban Asunción Ferri-Morales |
| author_sort | Rubén Arroyo-Fernández |
| collection | DOAJ |
| description | Correct blinding is essential for preventing potential biases. The aim of this study was to assess the blinding of participants and a therapist following treatment with transcranial direct current stimulation in subjects with fibromyalgia using James’ and Bang’s blinding indexes. Eighty subjects were randomly allocated either active or sham stimulation groups in an intervention of five sessions lasting 20 min each. A questionnaire was delivered to both the therapist and patients after the last session to record their guess of which treatment had been applied. No differences between the groups were noted at baseline in terms of demographic or clinical data. James’ BI was 0.83 (CI 95%: 0.76–0.90) for the patients and 0.55 (CI 95%: 0.45–0.64) for the therapist. Bang’s BI for subjects was −0.08 (CI 95%: −0.24–0.09) and −0.8 (CI 95%: −0.26–0.1) for the active and sham transcranial direct current stimulation groups, respectively. Bang’s BI for the therapist was 0.21 (CI 95%: −0.02–0.43) and 0.13 (CI 95%: −0.09–0.35) for the active and sham transcranial direct current stimulation groups, respectively. Protocols of active and sham transcranial direct current stimulation applied in this study have shown satisfactory blinding of the therapist and subjects with fibromyalgia. |
| first_indexed | 2024-03-10T06:41:10Z |
| format | Article |
| id | doaj.art-21dbb0bf9b3046b28acd49baab5772d4 |
| institution | Directory Open Access Journal |
| issn | 2076-3425 |
| language | English |
| last_indexed | 2024-03-10T06:41:10Z |
| publishDate | 2021-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Brain Sciences |
| spelling | doaj.art-21dbb0bf9b3046b28acd49baab5772d42023-11-22T17:37:36ZengMDPI AGBrain Sciences2076-34252021-10-011110133510.3390/brainsci11101335A New Approach to Assess Blinding for Transcranial Direct Current Stimulation Treatment in Patients with Fibromyalgia. A Randomized Clinical TrialRubén Arroyo-Fernández0Juan Avendaño-Coy1Rafael Velasco-Velasco2Rocío Palomo-Carrión3Elisabeth Bravo-Esteban4Asunción Ferri-Morales5Physiotherapy Unit, Nª Sª del Prado Hospital, 45600 Talavera de la Reina, SpainFaculty of Physiotherapy and Nursing, University of Castilla-La Mancha, 45071 Toledo, SpainFaculty of Physiotherapy and Nursing, University of Castilla-La Mancha, 45071 Toledo, SpainFaculty of Physiotherapy and Nursing, University of Castilla-La Mancha, 45071 Toledo, SpainFaculty of Physiotherapy and Nursing, University of Castilla-La Mancha, 45071 Toledo, SpainFaculty of Physiotherapy and Nursing, University of Castilla-La Mancha, 45071 Toledo, SpainCorrect blinding is essential for preventing potential biases. The aim of this study was to assess the blinding of participants and a therapist following treatment with transcranial direct current stimulation in subjects with fibromyalgia using James’ and Bang’s blinding indexes. Eighty subjects were randomly allocated either active or sham stimulation groups in an intervention of five sessions lasting 20 min each. A questionnaire was delivered to both the therapist and patients after the last session to record their guess of which treatment had been applied. No differences between the groups were noted at baseline in terms of demographic or clinical data. James’ BI was 0.83 (CI 95%: 0.76–0.90) for the patients and 0.55 (CI 95%: 0.45–0.64) for the therapist. Bang’s BI for subjects was −0.08 (CI 95%: −0.24–0.09) and −0.8 (CI 95%: −0.26–0.1) for the active and sham transcranial direct current stimulation groups, respectively. Bang’s BI for the therapist was 0.21 (CI 95%: −0.02–0.43) and 0.13 (CI 95%: −0.09–0.35) for the active and sham transcranial direct current stimulation groups, respectively. Protocols of active and sham transcranial direct current stimulation applied in this study have shown satisfactory blinding of the therapist and subjects with fibromyalgia.https://www.mdpi.com/2076-3425/11/10/1335transcranial direct current stimulationfibromyalgiaplaceboblindingJames’ indexBang’s index |
| spellingShingle | Rubén Arroyo-Fernández Juan Avendaño-Coy Rafael Velasco-Velasco Rocío Palomo-Carrión Elisabeth Bravo-Esteban Asunción Ferri-Morales A New Approach to Assess Blinding for Transcranial Direct Current Stimulation Treatment in Patients with Fibromyalgia. A Randomized Clinical Trial Brain Sciences transcranial direct current stimulation fibromyalgia placebo blinding James’ index Bang’s index |
| title | A New Approach to Assess Blinding for Transcranial Direct Current Stimulation Treatment in Patients with Fibromyalgia. A Randomized Clinical Trial |
| title_full | A New Approach to Assess Blinding for Transcranial Direct Current Stimulation Treatment in Patients with Fibromyalgia. A Randomized Clinical Trial |
| title_fullStr | A New Approach to Assess Blinding for Transcranial Direct Current Stimulation Treatment in Patients with Fibromyalgia. A Randomized Clinical Trial |
| title_full_unstemmed | A New Approach to Assess Blinding for Transcranial Direct Current Stimulation Treatment in Patients with Fibromyalgia. A Randomized Clinical Trial |
| title_short | A New Approach to Assess Blinding for Transcranial Direct Current Stimulation Treatment in Patients with Fibromyalgia. A Randomized Clinical Trial |
| title_sort | new approach to assess blinding for transcranial direct current stimulation treatment in patients with fibromyalgia a randomized clinical trial |
| topic | transcranial direct current stimulation fibromyalgia placebo blinding James’ index Bang’s index |
| url | https://www.mdpi.com/2076-3425/11/10/1335 |
| work_keys_str_mv | AT rubenarroyofernandez anewapproachtoassessblindingfortranscranialdirectcurrentstimulationtreatmentinpatientswithfibromyalgiaarandomizedclinicaltrial AT juanavendanocoy anewapproachtoassessblindingfortranscranialdirectcurrentstimulationtreatmentinpatientswithfibromyalgiaarandomizedclinicaltrial AT rafaelvelascovelasco anewapproachtoassessblindingfortranscranialdirectcurrentstimulationtreatmentinpatientswithfibromyalgiaarandomizedclinicaltrial AT rociopalomocarrion anewapproachtoassessblindingfortranscranialdirectcurrentstimulationtreatmentinpatientswithfibromyalgiaarandomizedclinicaltrial AT elisabethbravoesteban anewapproachtoassessblindingfortranscranialdirectcurrentstimulationtreatmentinpatientswithfibromyalgiaarandomizedclinicaltrial AT asuncionferrimorales anewapproachtoassessblindingfortranscranialdirectcurrentstimulationtreatmentinpatientswithfibromyalgiaarandomizedclinicaltrial AT rubenarroyofernandez newapproachtoassessblindingfortranscranialdirectcurrentstimulationtreatmentinpatientswithfibromyalgiaarandomizedclinicaltrial AT juanavendanocoy newapproachtoassessblindingfortranscranialdirectcurrentstimulationtreatmentinpatientswithfibromyalgiaarandomizedclinicaltrial AT rafaelvelascovelasco newapproachtoassessblindingfortranscranialdirectcurrentstimulationtreatmentinpatientswithfibromyalgiaarandomizedclinicaltrial AT rociopalomocarrion newapproachtoassessblindingfortranscranialdirectcurrentstimulationtreatmentinpatientswithfibromyalgiaarandomizedclinicaltrial AT elisabethbravoesteban newapproachtoassessblindingfortranscranialdirectcurrentstimulationtreatmentinpatientswithfibromyalgiaarandomizedclinicaltrial AT asuncionferrimorales newapproachtoassessblindingfortranscranialdirectcurrentstimulationtreatmentinpatientswithfibromyalgiaarandomizedclinicaltrial |