Low Back Pain
Conditions
Keywords
osteopathic manipulative treatment, cognitive therapy, chronic low back pain, pain, disability
Brief summary
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
Interventions
manual treatment using osteopathic procedure. 8 sessions for a 12 week study period
OTHERusual care
administration of non-steroid inflammatory drug according to international guidelines
OTHERosteopathic treatment + cognitive training
This intervention is a combination of manipulative osteopathic treatment and cognitive training to be administered each week for a 12-week study period
Sponsors
Hospital General Universitario Santa Lucia
Niguarda Hospital
Orthoplus
Come Collaboration
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* aged between 30 and 65 y * diagnosis of aspecific chronic low back pain * minimum of 3 on the NRS score
Exclusion criteria
* Neuropathic pain or chronic widespread pain * Low back spinal surgery in the last three years * Low back spinal surgery to osteoporosis and/or traumatic fractures * Rheumatic disease * Pregnancy or having a baby in the last 12 months * Painful disease in evidence through RX, MRI or CT in the last 6 months (listesis, moderate arthrosis, severe, algodystrophy etc.). * The subjects have not to be treated with physical or manual therapies or psychotherapy in the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in NRS at 3 months | 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 |
| Change in RMDQ at 3 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BPQ | 1 month - 3 month - 6 month | Baseline Changes in Body Perception Questionnaire |
| Changes in DASS-21 | 1 month - 3 month - 6 month | Baseline changes in Depression Anxiety Stress Scales-21. The scale ranges from 0 to 36, where 36 indicates severe depression, anxiety and stress |
| Changes in SF-36 | 1 month - 3 month - 6 month | 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. |
| Rate of AER | 1 month - 3 month - 6 month | Number of participants with Adverse Events Reporting (AER) calculated by the rates |
| Changes in SCWT | 1 month - 3 month - 6 month | 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. |
| Changes in CSI | 1 month - 3 month - 6 month | 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. |
| Change in NRS at 1 month | 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 |
| Change in NRS at 6 months | 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 |
| Change in RMDQ at 1 month | 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) |
| Change in RMDQ at 6 months | 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) |
| TMT | 1 month - 3 month - 6 month | Trail Making Test |
| Changes in Oswestry | 1 month - 3 month - 6 month | 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 |
Countries
Italy
Contacts
Primary ContactFrancesco Cerritelli, PhD
Outcome results
None listed