Effects of Osteopathic Treatment With Cognitive Training on Low Back Pain

Come Collaboration

Status: Unknown

Conditions: Low Back Pain

Treatments: Other: osteopathic treatment + cognitive training; Other: osteopathic treatment; Other: usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04277039

COME-01-20

Details and patient eligibility

About

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

Enrollment: 216 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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216 participants in 3 patient groups

OMT+CT

Experimental group

Description:

It consists of 8 sessions of osteopathic treatment and two 20-min sessions of cognitive training per week per 2 months

Treatment:

Other: osteopathic treatment + cognitive training

osteopathic treatment

Active Comparator group

Description:

It consists of 8 sessions of osteopathic treatment throughout the 2-month study period

Treatment:

Other: osteopathic treatment

usual care

Other group

Description:

patients will continue the routine care as established by international guidelines

Treatment:

Other: usual care