Multimodal Intervention in Patients With Non-specific Chronic Low Back Pain: the HEALTHY BACK Project

NCT06114264 | Completed

• 1 other identifier: iBSGranada
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is one of the most common health problems seen in the primary care. Chronic low back pain is localized between the inferior limit of the ribs and the sacral region, and persist more than 12 weeks. In most cases, it is attributed to a non-specific cause and classified as non-specific chronic low back pain (NSCLBP). No previous study has included a multimodal supervised program in patients with NSCLBP. The primary aim of this study is to determine the effectiveness of exercise + behaviour change + education + mindfulness programs (intervention 1) and an intervention including intervention 1 following functional resistance training (Intervention 2) on endogenous pain modulation, disability, muscle strength/endurance, quality of life, gait parameters, levels of physical activity, sedentary behaviour and psychological health in patients with NSCLBP.

Conditions

Pain, Chronic; Neurologic Manifestations; Back Pain; Low Back Pain; Behavior, Health

Keywords

exercise; behaviour change; education; mindfulness; pain; strength

Outcome Measures

Primary Outcomes (9)

• Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 2 months

  It will be measured using the sphygmomanometer on the upper arm contralateral to the most painful lumbar side.

  Change from baseline at 2 months (Posttest minus Pretest)

• Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 3.5 months

  It will be measured using the sphygmomanometer on the upper arm contralateral to the most painful lumbar side.

  Change from baseline at 3.5 months (Posttest minus Pretest)

• Change from baseline Conditioned Pain Modulation (CPM) in the lower back at 5 months

  It will be measured using the sphygmomanometer on the upper arm contralateral to the most painful lumbar side.

  Change from baseline at 5 months (Retest minus Pretest)

• Change from baseline Temporal Sumation of Pain (TSP) in the lower back at 2 months

  It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).

  Change from baseline at 2 months (Posttest minus Pretest)

• Change from baseline Temporal Sumation of Pain (TSP) in the lower back at 3.5 months

  It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).

  Change from baseline at 3.5 months (Posttest minus Pretest)

• Change from baseline Temporal Sumation of Pain (TSP) in the lower back at 5 months

  It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).

  Change from baseline at 5 months (Posttest minus Pretest)

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

  It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).

  Change from baseline at 2 months (Posttest minus Pretest)

• Change from baseline Pressure pain threshold (PPT) in the lower back at 3.5 months control and intervention group 1

  It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).

  Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)

• Change from baseline Pressure pain threshold (PPT) in the lower back at 5 months control and intervention group 1

  It will be measured using a hand-held standard pressure algometer (FPK 20, Wagner Instruments, Greenwich, CT, USA).

  Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)

Secondary Outcomes (78)

• Change from baseline Disability due to pain at 2 months

  Change from baseline at 2 months (Posttest minus Pretest)

• Change from baseline Disability due to pain at 3.5 months

  Change from baseline at 3.5 months (Posttest minus Pretest)

• Change from baseline Disability due to pain at 5 months control and intervention group 1

  Change from baseline at 5 months control and intervention group 1 (Retest minus Pretest)

• Change from baseline Pain intensity at 2 months

  Change from baseline at 2 months (Posttest minus Pretest)

• Change from baseline Pain intensity at 3.5 months control and intervention group 1

  Change from baseline at 3.5 months control and intervention group 1 (Posttest minus Pretest)

Study Arms (2)

Control Group

SHAM COMPARATOR

This group will not receive any treatment during the intervention period.

Other: Control group

Multimodal + Resistance Program

EXPERIMENTAL

Multimodal program including exercise program 2 days / week (45 minutes per session) during a period of 8 weeks + Behaviour change program daily /24 hours via a wrist-worn activity prompting device during a period of 8 weeks + Education program 2 days / week (1.5 hour per session, except the final session lasting 2 hours) during a period of 3 weeks + Mindfulness intervention 1 day / week (2.5 hour per session) during a period of 8 weeks, and will continue with an extended exercise program (functional resistance training) additionally 3 days / week (50 minutes per session) during 8 weeks.

Behavioral: Multimodal + Resistance Programs

Interventions

Multimodal + Resistance Programs BEHAVIORAL

Exercise: will focus on working the all body by performing functional tasks. Behaviour change: An 'idle alert' of the wrist-worn activity prompter will be set to vibrate after 45 min without movement. Participants will be encouraged to take a 1-2 min activity break. Education: The basic contents will explain to the patient the main mechanism of chronic pain (pain as a protective system, consequences, etc). 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 and a Mindfulness practice. Resistance functional exercises will replicate functional movements, such as standing from a bed, carrying bags, picking up groceries from the ground, etc.

Multimodal + Resistance Program

Control group OTHER

No experimental intervention. The group will receive the same multimodal intervention as the experimental group when the experimental period is over.

Control Group

Eligibility Criteria

• Age: 18 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 al1.
• 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.

You may not qualify if:

• Be under 20 years or over 65 years old.
• 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
• Instituto de Salud Carlos III: collaborator
• University Hospital Virgen de las Nieves: collaborator

Study Sites (1)

iBS.Granada

Granada, Granada, 18012, Spain

Location

Related Publications (1)

• Tsiarleston G, Lopez-Fernandez MD, Pavon-Munoz R, Aguilera-Garcia I, Lopez-Corchon M, Delgado-Fernandez M, Castellote-Caballero MY, Donoso B, Mesa-Ruiz AM, Pozuelo-Calvo R, Rios-Ortiz AM, Alvarez-Corral G, Marin-Jimenez N, Martinez-Garcia D, Chirosa Rios IJ, Segura-Jimenez V. Multimodal intervention based on physical exercise, mindfulness, behaviour change and education to improve pain and health in patients with chronic primary low back pain: a study protocol of the HEALTHYBACK randomised controlled trial. BMJ Open Sport Exerc Med. 2024 Nov 21;10(4):e002188. doi: 10.1136/bmjsem-2024-002188. eCollection 2024.

  PMID: 39610994 DERIVED

MeSH Terms

Conditions

Chronic Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Health Behavior; Motor Activity; Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

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: October 10, 2023
• First Posted: November 2, 2023
• Study Start: January 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)