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

NCT05443880 | Completed DMC

• 1 other identifier: IBS.Granada
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Exercise, mindfulness, sedentary behaviour, strength, pain

Outcome Measures

Primary Outcomes (6)

• Change from baseline Muscular fitness at 2 months: The trunk muscle strength/endurance

  It will be measured with the Biering-Sørensen test and the plank test.

  Change from baseline at 2 months (Postest minus Retest)

• Change from baseline Muscular fitness at 5 months: The trunk muscle strength/endurance

  It will be measured with the Biering-Sørensen test and the plank test.

  Change from baseline at 5 months (Retest minus Pretest)

• Change from baseline Muscular fitness at 2 months: lower body strength

  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 at 2 months (Postest minus Retest)

• Change from baseline Muscular fitness at 5 months: lower body strength

  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 at 5 months (Retest minus Pretest)

• Change from baseline Muscular fitness at 2 months: upper body strength

  It will be measured with the handgrip strength test (TKK 5101 Grip-D; Takey, Tokyo, Japan dynamometer).

  Change from baseline at 2 months (Postest minus Retest)

• Change from baseline Muscular fitness at 5 months: upper body strength

  It will be measured with the handgrip strength test (TKK 5101 Grip-D; Takey, Tokyo, Japan dynamometer).

  Change from baseline at 5 months (Retest minus Pretest)

Other Outcomes (26)

• Change from baseline Pressure pain threshold (PPT) in the lower back at 2 months

  Change from baseline at 2 months (Postest minus Retest)

• Change from baseline Pressure pain threshold (PPT) in the lower back at 5 months

  Change from baseline at 5 months (Retest minus Pretest)

• Change from baseline Disability due to pain at 2 months

  Change from baseline at 2 months (Postest minus Retest)

Study Arms (3)

Exercise

EXPERIMENTAL

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

Behavioral: Exercise

Exercise + mindfulness

EXPERIMENTAL

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

Behavioral: Exercise + mindfulness

Control

OTHER

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

Other: Control group

Interventions

Exercise BEHAVIORAL

The exercise intervention will focus on working the core muscles, starting with low-intensity isometric contraction of the core muscles that stabilize the trunk; increasing intensity by performing functional tasks (phase 1: independent isometric contraction of transversus-abdominis and multifidus, phase 2: co-contraction and functional tasks of the deep trunk muscles; phase 3: functional task with load; phase 4: functional task with unstable surface)

Exercise

Exercise + mindfulness BEHAVIORAL

The Mindfulness Based Stress Reduction (MBSR) program will strictly follow the protocol developed by Jon Kabat Zinn. Each session will include three activities: the presentation of a topic, moments of dialogue and exploration in group (using appreciative inquiry) and a Mindfulness practice. Participants will be provided with workbooks, audios with guided meditations, and instructions for practice at home. In addition, the Exercise + mindfulness intervention will include the exercise program described in the exercise intervention.

Exercise + mindfulness

Control group OTHER

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.

Control

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IBS Granada: lead
• European Social Fund: collaborator
• University Hospital Virgen de las Nieves: collaborator
• Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental: collaborator

Study Sites (1)

IBS.Granada

Granada, Spain

Location

MeSH Terms

Conditions

Low Back Pain; Motor Activity; Pain

Interventions

Exercise; Mindfulness; Control Groups

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: July 5, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)