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Pilates in Women With Chronic Low Back Pain

Primary Purpose

Back Pain, Low

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pilates exercise program
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain, Low

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • lumbar or lumbosacral pain (with or without radicular pain) for at least six months;
  • a score higher than 6/50 on the Oswestry Disability Index (ODI)
  • absence of any back treatment for the last three months.

Exclusion Criteria:

  • body mass index > 30 kg/m2
  • prior surgery of the pelvis,
  • spinal column or lower extremity
  • scoliosis;
  • systemic or degenerative disease
  • history of neurological diseases or deficits not related to back pain
  • pregnancy or hypertension.

Sites / Locations

  • Faculty of Physical Activity and Sport Sciences. University of Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EG: Exercise Group

CG: Control Group

Arm Description

Pilates exercise program (1 h x 2 sessions per week x 2 months)

Usual lifestyle

Outcomes

Primary Outcome Measures

FRR was calculated by dividing the maximal EMG amplitude during flexion by the minimum EMG amplitude at full flexion. The mean of the 3 trials performed was used to determine the FRR for each muscle for each subject.
A lower FRR indicated a greater state of muscle relaxation. Asymmetry in muscle activity between both (right and left) ES muscles was calculated as their mean difference in RMS in the three flexion-extension tasks. Asymmetry in the FRR was calculated as the absolute difference between FRR of the right and left ES muscles.

Secondary Outcome Measures

Full TFRoM was calculated as the average TFRoM from the three flexion-extension tasks.
To obtain the full trunk flexion ROM (TFRoM), the angular position of the inertial EMG sensor (attached with a kinesio-tape at T3 vertebrae) was measured from the start to the end of the flexion movement.
The version adapted to the Spanish population of the Low Back Outcome Score (LBOS) questionnaire was used to measure self-reported functional capacity.
LBOS was measured at pre-intervention (T0) and pos-intervention (T8).
A 10-cm Visual Analog Scale (VAS) was used to evaluate pain intensity
VAS was measured at pre-intervention (T0) and pos-intervention (T8).

Full Information

First Posted
February 10, 2022
Last Updated
February 21, 2022
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT05264311
Brief Title
Pilates in Women With Chronic Low Back Pain
Official Title
Effect of a Pilates Exercise Program on the Flexion-relaxation Rate in Women With Chronic
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

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 effect of a Pilates exercise program (PEP) on the flexo-relaxation ratio (FRR) of the erector spinae (ES) muscle during standing maximal trunk flexion/extension in women with chronic low-back pain (LBP). A secondary goal is to investigate the effect of PEP on full trunk flexion ROM (TFRoM), pain intensity and functional capacity and analyse their relationship with the FRR.
Detailed Description
Purpose: To evaluate the effect of a Pilates exercise program (PEP) on the flexo-relaxation ratio (FRR) of the erector spinae (ES) muscle during standing maximal trunk flexion/extension in women with chronic low-back pain (LBP). A secondary goal was to investigate the effect of PEP on full trunk flexion ROM (TFRoM), pain intensity and functional capacity and analyse their relationship with the FRR. Material and methods: Thirty women with chronic LPB were randomly assigned to either PEP (EG, n=15) or control group (CG=15). EG followed an 8-week PEP while no specific intervention was carried out on the controls. Before and after this period all variables were recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Low

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EG: Exercise Group
Arm Type
Experimental
Arm Description
Pilates exercise program (1 h x 2 sessions per week x 2 months)
Arm Title
CG: Control Group
Arm Type
No Intervention
Arm Description
Usual lifestyle
Intervention Type
Other
Intervention Name(s)
Pilates exercise program
Other Intervention Name(s)
Core strength exercise program
Intervention Description
The Pilates Exercise Program (PEP) (1 h x 2 sessions per week x 2 months) was delivered by one Pilates professional (with a mean of 6.5 years of experience in Pilates). The PEP carried out by Pilates instructor has been published in a previous study [31]. The exercises focused on core stability, posture, breathing, flexibility, strength, and muscle control, being the active awareness of the use of trunk muscles to stabilize the pelvic-lumbar region the main approach. The exercises performed were: the hundred, the rolled up, single leg circles with bent leg, spine stretch, rolling like a ball and single leg stretch. Each exercise was performed as follows: 4 repetitions of 30 seconds with 2 minutes of recovery between repetitions. In order to complete the 60 minutes session two exercises: the "superman" and the double leg bridge were added to the mentioned PEP.
Primary Outcome Measure Information:
Title
FRR was calculated by dividing the maximal EMG amplitude during flexion by the minimum EMG amplitude at full flexion. The mean of the 3 trials performed was used to determine the FRR for each muscle for each subject.
Description
A lower FRR indicated a greater state of muscle relaxation. Asymmetry in muscle activity between both (right and left) ES muscles was calculated as their mean difference in RMS in the three flexion-extension tasks. Asymmetry in the FRR was calculated as the absolute difference between FRR of the right and left ES muscles.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Full TFRoM was calculated as the average TFRoM from the three flexion-extension tasks.
Description
To obtain the full trunk flexion ROM (TFRoM), the angular position of the inertial EMG sensor (attached with a kinesio-tape at T3 vertebrae) was measured from the start to the end of the flexion movement.
Time Frame
2 months
Title
The version adapted to the Spanish population of the Low Back Outcome Score (LBOS) questionnaire was used to measure self-reported functional capacity.
Description
LBOS was measured at pre-intervention (T0) and pos-intervention (T8).
Time Frame
2 months
Title
A 10-cm Visual Analog Scale (VAS) was used to evaluate pain intensity
Description
VAS was measured at pre-intervention (T0) and pos-intervention (T8).
Time Frame
2 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: lumbar or lumbosacral pain (with or without radicular pain) for at least six months; a score higher than 6/50 on the Oswestry Disability Index (ODI) absence of any back treatment for the last three months. Exclusion Criteria: body mass index > 30 kg/m2 prior surgery of the pelvis, spinal column or lower extremity scoliosis; systemic or degenerative disease history of neurological diseases or deficits not related to back pain pregnancy or hypertension.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Ferri-Caruana, PhD
Organizational Affiliation
Department of Physical Activity and Sports. University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Activity and Sport Sciences. University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilates in Women With Chronic Low Back Pain

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