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| Name | Class |
|---|---|
| Hospital General Universitario Santa Lucia | OTHER |
| Niguarda Hospital | OTHER |
| Orthoplus | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OMT+CT | Experimental | It consists of 8 sessions of osteopathic treatment and two 20-min sessions of cognitive training per week per 2 months |
|
| osteopathic treatment | Active Comparator | It consists of 8 sessions of osteopathic treatment throughout the 2-month study period |
|
| usual care | Other | patients will continue the routine care as established by international guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| osteopathic treatment + cognitive training | Other | This intervention is a combination of manipulative osteopathic treatment and cognitive training to be administered each week for a 12-week study period |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month - 3 month - 6 month |
| Changes in Oswestry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Cerritelli, PhD | Contact | +393394332801 | francesco.cerritelli@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Cerritelli, PhD | Come Collaboration | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Lucia Foundation | Rome | Lazio | 00179 | Italy |
available upon request
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| osteopathic treatment | Other | manual treatment using osteopathic procedure. 8 sessions for a 12 week study period |
|
| usual care | Other | administration of non-steroid inflammatory drug according to international guidelines |
|
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
| 1 month - 3 month - 6 month |
| BPQ | Baseline Changes in Body Perception Questionnaire | 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 | 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. | 1 month - 3 month - 6 month |
| Rate of AER | Number of participants with Adverse Events Reporting (AER) calculated by the rates | 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." | 1 month - 3 month - 6 month |
| TMT | Trail Making Test | 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 | 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 | 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) | 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) | 6 months |
| Niguarda hospital | Milan | Lombardy | 20161 | Italy |
|
| Orthoplus | Bolzano | Trentino-Alto Adige | 39100 | Italy |
|
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D026741 | Physical Therapy Modalities |