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

Not Applicable

Active, not recruiting

• Conditions: Low Back Pain
• Interventions: Behavioral: Exercise; Behavioral: Exercise + mindfulness; Other: Control group

• Registration Number: NCT05443880
• Lead Sponsor: IBS Granada

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-07-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	The exercise intervention will undergo a exercise program 2 days / week (45 minutes per session) during a period of 8 weeks.
Exercise + mindfulness	Exercise + mindfulness	The exercise + mindfulness intervention will carry out a an exercise intervention together with mindfulness intervention 1 day / week (2.5 hour per session).
Control	Control group	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

Primary Outcome Measures

Name	Time	Method
Change from baseline Muscular fitness at 2 months: lower body strength	Change from baseline at 2 months (Postest minus Retest)	It will be measured by the 30s chair stand test. Upper body strength (maximal isometric strength) will be measured with the handgrip strength test (TKK dynamometer).
Change from baseline Muscular fitness at 5 months: lower body strength	Change from baseline at 5 months (Retest minus Pretest)	It will be measured by the 30s chair stand test. Upper body strength (maximal isometric strength) will be measured with the handgrip strength test (TKK dynamometer).
Change from baseline Muscular fitness at 2 months: The trunk muscle strength/endurance	Change from baseline at 2 months (Postest minus Retest)	It will be measured with the Biering-Sørensen test and the plank test.
Change from baseline Muscular fitness at 5 months: The trunk muscle strength/endurance	Change from baseline at 5 months (Retest minus Pretest)	It will be measured with the Biering-Sørensen test and the plank test.
Change from baseline Muscular fitness at 2 months: upper body strength	Change from baseline at 2 months (Postest minus Retest)	It will be measured with the handgrip strength test (TKK 5101 Grip-D; Takey, Tokyo, Japan dynamometer).
Change from baseline Muscular fitness at 5 months: upper body strength	Change from baseline at 5 months (Retest minus Pretest)	It will be measured with the handgrip strength test (TKK 5101 Grip-D; Takey, Tokyo, Japan dynamometer).

Trial Locations

Locations (1)

IBS.Granada; 🇪🇸 Granada, Spain