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Clinical Trials/NCT05264311
NCT05264311
Completed
Not Applicable

Effect of a Pilates Exercise Program on the Flexion-relaxation Rate in Women With Chronic

University of Valencia1 site in 1 country30 target enrollmentJune 1, 2020
ConditionsBack Pain, Low

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Back Pain, Low
Sponsor
University of Valencia
Enrollment
30
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
July 2, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marco Romagnoli

Principal Investigator

University of Valencia

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.

Outcomes

Primary Outcomes

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.

Time Frame: 2 months

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 Outcomes

  • The version adapted to the Spanish population of the Low Back Outcome Score (LBOS) questionnaire was used to measure self-reported functional capacity.(2 months)
  • A 10-cm Visual Analog Scale (VAS) was used to evaluate pain intensity(2 months)
  • Full TFRoM was calculated as the average TFRoM from the three flexion-extension tasks.(2 months)

Study Sites (1)

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