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Online Pilates in Individuals With Chronic Low Back Pain

Primary Purpose

Low Back Pain, Chronic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pilates method
Pain education
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, Exercise Movement Techniques, Exercise, Chronic Pain, Telerehabilitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pilates Group

    Control Group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Functional performance associated to back pain
    Functional performance associated with low back pain measured by Roland Morris Disability Questionnaire (24 items - more items is related to worse disability)
    Kinesiophobia
    Kinesiophobia measured by Tampa Scale of Kinesiophobia (17 to 68 points)
    Patient global impression of change
    Patient global impression of change measured by a scale with seven points, where 1 is equal to no change or worse and 7 is much better

    Full Information

    First Posted
    October 10, 2022
    Last Updated
    October 14, 2022
    Sponsor
    Universidade Federal do Rio Grande do Norte
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05578365
    Brief Title
    Online Pilates in Individuals With Chronic Low Back Pain
    Official Title
    Effects of an Online Pilates Protocol in Individuals With Chronic Low Back Pain: Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 31, 2022 (Anticipated)
    Primary Completion Date
    March 2023 (Anticipated)
    Study Completion Date
    April 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Rio Grande do Norte

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    Low back pain is one of the main causes of disability in the world, and physical inactivity is associated with its development. In this sense, Pilates can be used both in the treatment and preventively for this symptomatology. Thus, the aim 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 involving men and women between 18 and 60 years of age with a history of non-specific chronic low back pain and a minimum pain intensity equal to 3 points on the numeric pain scale. Research participants will perform a pre-intervention (EV1) and post-intervention (EV2) assessment, both online. Pain sensation, functional performance, kinesiophobia and perception of global change will be the outcomes evaluated through the following instruments: Numerical Pain Scale, Roland Morris Questionnaire, Tampa Scale for kinesiophobia and Patient Global Impression of Change Scale. Participants included in the study will be randomized into two groups with separate interventions, both lasting eight weeks: online Pilates group and control group. The control group will receive information about self-management of low back pain, pain education, and changes in lifestyle habits; the Pilates group, besides having access to the same information as the control group, will undergo 16 Pilates sessions performed online (2 times/week). The statistical analysis will be done through the independent t test and the Mann-whitney test to investigate the differences between the groups (Pilates online x control), while the paired t test and the Wilcoxon test will be applied to evaluate the effect of the time variable (Pre x Post), considering a significance level of 5%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain, Chronic Pain
    Keywords
    low back pain, Exercise Movement Techniques, Exercise, Chronic Pain, Telerehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    78 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pilates Group
    Arm Type
    Experimental
    Arm Description
    Pilates method exercise program, performed online, 8 weeks long, twice a week + information on self-management and pain education once a week.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Information on self-management of low back pain, pain education, and changes in lifestyle habits once a week during 8 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Pilates method
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Pain education
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pain sensation
    Description
    Painful sensation measured by numerical pain rating scale (11 points scale)
    Time Frame
    Change from baseline in pain sensation at eight weeks after the intervention
    Secondary Outcome Measure Information:
    Title
    Functional performance associated to back pain
    Description
    Functional performance associated with low back pain measured by Roland Morris Disability Questionnaire (24 items - more items is related to worse disability)
    Time Frame
    Change from baseline in functional performance at eight weeks after the intervention
    Title
    Kinesiophobia
    Description
    Kinesiophobia measured by Tampa Scale of Kinesiophobia (17 to 68 points)
    Time Frame
    Change from baseline in kinesiophobia at eight weeks after the intervention
    Title
    Patient global impression of change
    Description
    Patient global impression of change measured by a scale with seven points, where 1 is equal to no change or worse and 7 is much better
    Time Frame
    The Patient global impression of change after eight weeks of intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liane B Macedo, PhD
    Phone
    +55 (84) 3342-2287
    Email
    liane.macedo@ufrn.br

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Online Pilates in Individuals With Chronic Low Back Pain

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