Online Pilates in Individuals With Chronic Low Back Pain

NCT05578365 | Unknown

• 1 other identifier: LBPOP22-2
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effects of the Pilates method, performed online, in individuals with chronic low back pain. This is a randomized controlled trial consisting of two arms.

Conditions

Low Back Pain; Chronic Pain

Keywords

low back pain; Exercise Movement Techniques; Exercise; Chronic Pain; Telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Pain sensation

  Painful sensation measured by numerical pain rating scale (11 points scale)

  Change from baseline in pain sensation at eight weeks after the intervention

Secondary Outcomes (3)

• Functional performance associated to back pain

  Change from baseline in functional performance at eight weeks after the intervention

• Kinesiophobia

  Change from baseline in kinesiophobia at eight weeks after the intervention

• Patient global impression of change

  The Patient global impression of change after eight weeks of intervention

Study Arms (2)

Pilates Group

EXPERIMENTAL

Pilates method exercise program, performed online, 8 weeks long, twice a week + information on self-management and pain education once a week.

Other: Pilates method

Control Group

ACTIVE COMPARATOR

Information on self-management of low back pain, pain education, and changes in lifestyle habits once a week during 8 weeks.

Other: Pain education

Interventions

Pilates method OTHER

Individuals in the Pilates group will perform specific exercises online. There will be 16 sessions, lasting 60 minutes, with 10 minutes of warm-up, 30 to 40 minutes of exercises focusing on the trunk stabilizers muscles, and 10 minutes of cool-down with relaxation, stretching, or meditation. In addition, the individuals will have access to the same information of the control group.

Pilates Group

Pain education OTHER

Individuals in the control group will receive information on self-management of low back pain, pain education, and changes in lifestyle habits once a week during 8 weeks.

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women with a history of chronic nonspecific low back pain (for more than 12 weeks) and minimum pain intensity of 3 on numerical pain rating scale.

You may not qualify if:

• Symptoms related to serious pathologies (such as fever, changes in sensibility, weight loss, constant pain);
• Recent history of spinal fracture, cancer, inflammatory diseases, nerve root involvement, spinal pathologies (such as ankylosing spondylitis, herniated disc with radiculopathy, advanced osteoporosis, spondylolysis, spondylolisthesis);
• Central neurological diseases (such as Parkinson's and stroke), psychiatric (such as depression or schizophrenia);
• Autoimmune diseases;
• Orthopedic surgery in the last year;
• Severe cardiovascular diseases;
• Decompensated metabolic diseases;
• Pregnancy.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Motor Activity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Liane B Macedo, PhD

CONTACT

+55 (84) 3342-2287; liane.macedo@ufrn.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: October 31, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share