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Effect of Pilates and Segmental Stabilization in Elderly People With Low Back Pain

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pilates Group
Segmental Stabilization group
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Chronic Pain, Exercise Therapy, Physical Therapy Modalities

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Non-specific low back pain for at least 3 months.
  • Intensity of pain equal to or greater than 3 cm.

Exclusion Criteria:

  • Specific low back pain.
  • Neurological involvement (radiculopathy, myelopathy).
  • Previous spinal surgery.
  • Any impediment to performing the exercises.
  • Having had recent surgeries.
  • Being on treatment for low back pain
  • Not having cognitive ability to perform the exercises or be submitted to the proposed assessments
  • Missing appointments three times in a row.

Sites / Locations

  • University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pilates Group

Segmental Stabilization Group

Arm Description

Participants will undergo 16 sessions, twice a week on alternate days through the following Pilates Method exercises: Pelvic Curl, Leg lift Supine, One leg circle modified and Hundred modified. There will be 4 sets of 5 repetitions in the first week, 6 repetitions in the second week, 7 repetitions in the third week, 8 repetitions in the fourth week, 9 repetitions in the fifth week, 10 repetitions in the sixth to eighth week.

Participants will undergo 16 consultations, twice a week on alternate days through the following Segmental Stabilization exercises: multifidus in prone position, transverse abdomen in four supports, transverse abdomen in dorsal decubitus and transverse abdomen associated with multifidus in position orthostatic. There will be 4 sets of 10 repetitions of 10 seconds in all appointments.

Outcomes

Primary Outcome Measures

Change from baseline in pain on the Numerical Pain Scale at week 16, 3 and 6 months after the end of treatment
The Numerical Pain Scale is a scale from 0 to 10, with 0 meaning total absence of pain and 10 the maximum bearable pain level by the patient. Change = Baseline, week 16, 3 and 6 months after the end of treatment.
Change from baseline in functional disability on the Oswestry Disability Index at week 16, 3, and 6 months after the end of treatment
The Oswestry Disability Index is a validated instrument for the Portuguese language with high reliability for a Brazilian population. The index is calculated by adding the total score (each section is from 0 to 5) and the total points equal to the sum of the points of the 10 sections. Interpretation is performed by means of percentage: 0% to 20% minimal disability, 21% to 40% moderate disability, 41% to 60% severe disability, 61% to 80% disability, 81% to 100% patient bedridden or exaggerating symptoms.

Secondary Outcome Measures

Change from baseline to Kinesiophobia on the Tampa Kinesiophobia Scale at week 16, 3, and 6 months after the end of treatment.
The Tampa scale of kinesiophobia consists of a self-administered questionnaire consisting of 17 questions that address pain and symptom intensity. The scores range from 1 to 4, with the answer "strongly disagree" equaling 1 point, "partially disagree" with 2 points, "partially agree" with 3 points, "strongly agree" with 4 points. To obtain the final total score, it is necessary to invert the scores of questions 4, 8, 12 and 16. The final score can be a minimum of 17 and a maximum of 68 points, the higher the score, the higher the degree of kinesiophobia
Change from baseline for confidence in balance to specific activities on the Activities-Specific Balance Confidence Scale at week 16, 3, and 6 months after the end of treatment.
The ABC scale - Activities-Specific Balance Confidence or Confidence in Balance for Specific Activities was developed to numerically quantify the level of confidence in carrying out specific activities without losing balance or becoming unstable. The higher the score, the greater the confidence to perform the activities.
Change from baseline to transversus abdominis muscle activation in the pressure biofeedback unit at 16 weeks, 3 and 6 months after the end of treatment.
The pressure biofeedback unit is a reliable instrument for the analysis of transversus abdominis muscle contraction. The lower the pressure, the greater the ability to activate this muscle.

Full Information

First Posted
September 8, 2021
Last Updated
September 8, 2021
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05047562
Brief Title
Effect of Pilates and Segmental Stabilization in Elderly People With Low Back Pain
Official Title
Effect of Pilates Method and Segmental Stabilization in Elderly People With Chronic Non-specific Low Back Pain: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

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
INTRODUCTION: Low back pain is an important health condition with great consequences from the socioeconomic point of view and is associated with high costs for the health system, absenteeism at work and reduced functional performance. It is considered one of the most relevant health problems in the elderly, with point prevalence estimates higher than for other musculoskeletal conditions. It can be defined as any pain between the last ribs and the lower gluteal folds, with or without pain in the lower limbs, manifesting itself acutely, subacutely or chronically. OBJECTIVE: To compare the effect of the Pilates method versus segmental stabilization in elderly people with chronic low back pain. METHOD: 60 elderly people with chronic low back pain will participate in the study and will be randomized into two groups: Pilates Group (GP) and Segmental Stabilization Group (SG). The two treatments will have 16 individual sessions, twice a week. Pain will be assessed using the visual analogue pain scale; functional disability, using the Oswestry disability index; excessive fear of movement and physical activity, by the Tampa scale of kinesiophobia; level of confidence in the balance for specific activities, by the ABC scale and; activation of the transversus abdominis muscle by pressure biofeedback. Individuals will be evaluated in four moments: before the first session, after the last session, three and six months after the end of the treatment to verify the effects in the medium term. Patient allocation and assessments will be performed by a blind examiner. Data will be analyzed using the ANOVA procedure and Tukey's Multiple Comparison test. The significance level will be 5%. A hipótese deste estudo é que o grupo que realiza exercícios de Pilates obtém ganhos mais obtem que o grupo que realiza exercícios de estabilização segmentar em todas as variáveis ao final do tratamento.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Chronic Pain, Exercise Therapy, Physical Therapy Modalities

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pilates Group
Arm Type
Active Comparator
Arm Description
Participants will undergo 16 sessions, twice a week on alternate days through the following Pilates Method exercises: Pelvic Curl, Leg lift Supine, One leg circle modified and Hundred modified. There will be 4 sets of 5 repetitions in the first week, 6 repetitions in the second week, 7 repetitions in the third week, 8 repetitions in the fourth week, 9 repetitions in the fifth week, 10 repetitions in the sixth to eighth week.
Arm Title
Segmental Stabilization Group
Arm Type
Active Comparator
Arm Description
Participants will undergo 16 consultations, twice a week on alternate days through the following Segmental Stabilization exercises: multifidus in prone position, transverse abdomen in four supports, transverse abdomen in dorsal decubitus and transverse abdomen associated with multifidus in position orthostatic. There will be 4 sets of 10 repetitions of 10 seconds in all appointments.
Intervention Type
Other
Intervention Name(s)
Pilates Group
Intervention Description
16 Pilates exercise sessions twice a week for 2 months.
Intervention Type
Other
Intervention Name(s)
Segmental Stabilization group
Intervention Description
16 sessions of segmental stabilization exercises, 2 times a week for 2 months.
Primary Outcome Measure Information:
Title
Change from baseline in pain on the Numerical Pain Scale at week 16, 3 and 6 months after the end of treatment
Description
The Numerical Pain Scale is a scale from 0 to 10, with 0 meaning total absence of pain and 10 the maximum bearable pain level by the patient. Change = Baseline, week 16, 3 and 6 months after the end of treatment.
Time Frame
Baseline, week 16, 3 and 6 months after completion of treatment.
Title
Change from baseline in functional disability on the Oswestry Disability Index at week 16, 3, and 6 months after the end of treatment
Description
The Oswestry Disability Index is a validated instrument for the Portuguese language with high reliability for a Brazilian population. The index is calculated by adding the total score (each section is from 0 to 5) and the total points equal to the sum of the points of the 10 sections. Interpretation is performed by means of percentage: 0% to 20% minimal disability, 21% to 40% moderate disability, 41% to 60% severe disability, 61% to 80% disability, 81% to 100% patient bedridden or exaggerating symptoms.
Time Frame
Baseline, week 16, 3 and 6 months after completion of treatment.
Secondary Outcome Measure Information:
Title
Change from baseline to Kinesiophobia on the Tampa Kinesiophobia Scale at week 16, 3, and 6 months after the end of treatment.
Description
The Tampa scale of kinesiophobia consists of a self-administered questionnaire consisting of 17 questions that address pain and symptom intensity. The scores range from 1 to 4, with the answer "strongly disagree" equaling 1 point, "partially disagree" with 2 points, "partially agree" with 3 points, "strongly agree" with 4 points. To obtain the final total score, it is necessary to invert the scores of questions 4, 8, 12 and 16. The final score can be a minimum of 17 and a maximum of 68 points, the higher the score, the higher the degree of kinesiophobia
Time Frame
Baseline, week 16, 3 and 6 months after completion of treatment.
Title
Change from baseline for confidence in balance to specific activities on the Activities-Specific Balance Confidence Scale at week 16, 3, and 6 months after the end of treatment.
Description
The ABC scale - Activities-Specific Balance Confidence or Confidence in Balance for Specific Activities was developed to numerically quantify the level of confidence in carrying out specific activities without losing balance or becoming unstable. The higher the score, the greater the confidence to perform the activities.
Time Frame
Baseline, week 16, 3 and 6 months after completion of treatment.
Title
Change from baseline to transversus abdominis muscle activation in the pressure biofeedback unit at 16 weeks, 3 and 6 months after the end of treatment.
Description
The pressure biofeedback unit is a reliable instrument for the analysis of transversus abdominis muscle contraction. The lower the pressure, the greater the ability to activate this muscle.
Time Frame
Baseline, week 16, 3 and 6 months after completion of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-specific low back pain for at least 3 months. Intensity of pain equal to or greater than 3 cm. Exclusion Criteria: Specific low back pain. Neurological involvement (radiculopathy, myelopathy). Previous spinal surgery. Any impediment to performing the exercises. Having had recent surgeries. Being on treatment for low back pain Not having cognitive ability to perform the exercises or be submitted to the proposed assessments Missing appointments three times in a row.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ariela Cruz
Phone
5524992192494
Email
ariela.tcruz@usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariela Cruz
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amelia Marques
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
University of Sao Paulo
City
Sao Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariela Cruz
Phone
5524992192494
Email
ariela.tcruz@usp.br

12. IPD Sharing Statement

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Effect of Pilates and Segmental Stabilization in Elderly People With Low Back Pain

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