The objective of this study is to verify whether the combined approach (osteopathic manipulative treatment -OMT- and cognitive training -CT) is more effective in the long term than the individual approaches (OMT or CT) in patients with chronic lumbar pain, evaluating the Numeric Rating Scale (NRS) and the Rolland-Morris Disability Questionnaire (RMDQ) questionnaire
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
216
This intervention is a combination of manipulative osteopathic treatment and cognitive training to be administered each week for a 12-week study period
manual treatment using osteopathic procedure. 8 sessions for a 12 week study period
administration of non-steroid inflammatory drug according to international guidelines
Santa Lucia Foundation
Rome, Lazio, Italy
Niguarda hospital
Milan, Lombardy, Italy
Orthoplus
Bolzano, Trentino-Alto Adige, Italy
Change in NRS at 3 months
Change from Baseline Numeric Rating Scale (NRS) of Pain at 3 months. NRS values range from 0-10, where 10 means highest pain and 0 no pain
Time frame: 3 months
Change in RMDQ at 3 months
Change from Baseline Rolland Morris Disability Questionnaire (RMDQ) at 3 months. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability)
Time frame: 3 months
Changes in CSI
Baseline changes in Central Sensitization index (CSI). CSI values ranges from 0 to 100. A score of more than 40 indicates the presence of central sensitisation.
Time frame: 1 month - 3 month - 6 month
Changes in Oswestry
Baseline changes in Oswestry Low Back Pain Disability Questionnaire. The questionnaire range is from 0 to 100. Zero is equated with no disability and 100 is the maximum disability possible
Time frame: 1 month - 3 month - 6 month
BPQ
Baseline Changes in Body Perception Questionnaire
Time frame: 1 month - 3 month - 6 month
Changes in DASS-21
Baseline changes in Depression Anxiety Stress Scales-21. The scale ranges from 0 to 36, where 36 indicates severe depression, anxiety and stress
Time frame: 1 month - 3 month - 6 month
Changes in SF-36
Baseline changes in the Short Form-36. The questionnaire is a health survey ranging from 0 to 100. The lower the score the more disability.
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Time frame: 1 month - 3 month - 6 month
Rate of AER
Number of participants with Adverse Events Reporting (AER) calculated by the rates
Time frame: 1 month - 3 month - 6 month
Changes in SCWT
Baseline changes in Stroop Color and Word Test. Word, color, and color-word T-Scores of 40 or less are considered "low." Word, color, and color-word T-Scores above 40 or are considered "normal."
Time frame: 1 month - 3 month - 6 month
TMT
Trail Making Test
Time frame: 1 month - 3 month - 6 month
Change in NRS at 1 month
Change from Baseline Numeric Rating Scale (NRS) of Pain at 1 month. NRS values range from 0-10, where 10 means highest pain and 0 no pain
Time frame: 1 month
Change in NRS at 6 months
Change from Baseline Numeric Rating Scale (NRS) of Pain at 6 months. NRS values range from 0-10, where 10 means highest pain and 0 no pain
Time frame: 6 months
Change in RMDQ at 1 month
Change from Baseline Rolland Morris Disability Questionnaire (RMDQ) at 1 month. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability)
Time frame: 1 month
Change in RMDQ at 6 months
Change from Baseline Rolland Morris Disability Questionnaire (RMDQ) at 6 months. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability)
Time frame: 6 months