Effects of Osteopathic Treatment With Cognitive Training on Low Back Pain

Study Overview
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Brief Summary
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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

Official Title
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Effects of Osteopathic Treatment in Combination With Cognitive Training on Low Back Pain Patients: a Randomised Sham-controlled Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: osteopathic treatment + cognitive training
* Other: osteopathic treatment
* Other: usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMT+CT<br>It consists of 8 sessions of osteopathic treatment and two 20-min sessions of cognitive training per week per 2 months | Other: osteopathic treatment + cognitive training<br>* This intervention is a combination of manipulative osteopathic treatment and cognitive training to be administered each week for a 12-week study period<br>|
| Active Comparator: osteopathic treatment<br>It consists of 8 sessions of osteopathic treatment throughout the 2-month study period | Other: osteopathic treatment<br>* manual treatment using osteopathic procedure. 8 sessions for a 12 week study period<br>|
| Other: usual care<br>patients will continue the routine care as established by international guidelines | Other: usual care<br>* administration of non-steroid inflammatory drug according to international guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, osteopathic manipulative treatment, cognitive therapy, chronic low back pain, disability