Effects of Osteopathic Treatment With Cognitive Training on Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04277039
• Other study ID #: COME-01-20
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: February 2020
• Source: Come Collaboration
• Contact: Francesco Cerritelli, PhD
• Phone: +393394332801
• Email: francesco.cerritelli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: June 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• osteopathic 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
• osteopathic treatment
manual treatment using osteopathic procedure. 8 sessions for a 12 week study period
• usual care
administration of non-steroid inflammatory drug according to international guidelines

Locations

Country	Name	City	State
Italy	Orthoplus	Bolzano	Trentino
Italy	Niguarda hospital	Milan	Lombardia
Italy	Santa Lucia Foundation	Roma	Lazio

Sponsors (4)

Lead Sponsor	Collaborator
Come Collaboration	Hospital General Universitario Santa Lucia, Niguarda Hospital, Orthoplus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	BPQ	Baseline Changes in Body Perception Questionnaire	1 month - 3 month - 6 month
Secondary	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
Secondary	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
Secondary	Rate of AER	Number of participants with Adverse Events Reporting (AER) calculated by the rates	1 month - 3 month - 6 month
Secondary	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
Secondary	TMT	Trail Making Test	1 month - 3 month - 6 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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