Exercise and Mindfulness in Patients With Non-specific Chronic Low Back Pain: The BACKFIT Project

IBS Granada

Status: Active, not recruiting

Conditions: Low Back Pain

Treatments: Behavioral: Exercise; Behavioral: Exercise + mindfulness; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05443880

IBS.Granada

Details and patient eligibility

About

Chronic low back pain is among the most common health problems seen in primary care, and is responsible for disability and absenteeism in our country. In most cases, it is attributed to a non-specific cause and classified as non-specific chronic low back pain (NSCLBP). Taking into consideration that multidimensional programs usually present more effectiveness reducing pain than unimodal programs, the current research investigates the role of unexplored multidimensional program (exercise and mindfulness) in NSCLBP. The primary aim of this project is to determine the effectiveness of a supervised exercise program (intervention 1) and a supervised exercise program + mindfulness (intervention 2) on pain, disability, trunk muscle endurance/strength, quality of life and gait parameters in patients with NSCLBP.

Enrollment: 105 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be previously diagnosed with NSCLBP pain by a healthcare professional according to the criteria established by O'Sullivan et al.
• Intend to participate in the intervention and perform all the tests included in the study.
• Able to read and understand informed consent, as well as the objective of the study.
• Able to walk and move without outside help.
• Able to communicate without problems
• Be between 18 and 65 years old.

Exclusion criteria

• Having spondylolysis, spondylolisthesis, canal stenosis, degenerative disc disease, and/or disc herniation, tumor, trauma or fracture of the lumbar and lower limbs, Cauda equina syndrome, and radicular leg pain (given that spine degeneration issues are commonly present in asymptomatic individuals and increase with age, only serious lumbar structural disorders were considered).
• Having lumbar surgery as source of pain.
• Having acute or terminal illness.
• Having medical prescription that prevents the performance of the tests.
• Having injury or circumstance that makes it impossible to perform the tests correctly.
• Having other physical or mental illness that prevents participating in the intervention.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Exercise

Experimental group

Description:

The exercise intervention will undergo a exercise program 2 days / week (45 minutes per session) during a period of 8 weeks.

Treatment:

Behavioral: Exercise

Exercise + mindfulness

Experimental group

Description:

The exercise + mindfulness intervention will carry out a an exercise intervention together with mindfulness intervention 1 day / week (2.5 hour per session).

Treatment:

Behavioral: Exercise + mindfulness

Control

Other group

Description:

The control group will be provided with the usual care received in the Physical Medicine and Rehabilitation Service: stretching, breathing and motor control exercises 2 days / week (45 minutes per session) during a period of 8 weeks

Treatment:

Other: Control group