Effects of Osteopathic Treatment With Cognitive Training on Low Back Pain

Not Applicable

• Conditions: Low Back Pain

• Registration Number: NCT04277039
• Lead Sponsor: Come Collaboration

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-18
• Study First Posted: 2020-02-20
• Last Update Posted: 2020-02-20
• Study Start: 2020-03-01
• Primary Completion: 2021-03-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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."
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 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)
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.
BPQ	1 month - 3 month - 6 month	Baseline Changes in Body Perception Questionnaire
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
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
TMT	1 month - 3 month - 6 month	Trail Making Test
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
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.
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)

Trial Locations

Locations (3)

Santa Lucia Foundation; 🇮🇹 Roma, Lazio, Italy

Niguarda hospital; 🇮🇹 Milan, Lombardia, Italy

Orthoplus; 🇮🇹 Bolzano, Trentino, Italy