CClinicalTrials.gg
CompletedNCT05264311Updated Mar 3, 2022

Pilates in Women With Chronic Low Back Pain

An interventional study of Pilates exercise program in Back Pain, Low, sponsored by University of Valencia. Completed at 1 site in Spain. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-03.

Sponsored by University of Valencia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Jun 2020, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Back Pain, Low
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    EG: Exercise Group

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

    Other: Pilates exercise program

  • No intervention
    CG: Control Group

    Usual lifestyle

Interventions

  • OtherPilates exercise program

    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.

    Also known as: Core strength exercise program

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 months

Secondary outcomes

  1. 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.

    Time frame: 2 months

  2. 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).

    Time frame: 2 months

  3. A 10-cm Visual Analog Scale (VAS) was used to evaluate pain intensity

    VAS was measured at pre-intervention (T0) and pos-intervention (T8).

    Time frame: 2 months

07

Study locations

1 site
  • Faculty of Physical Activity and Sport Sciences. University of Valencia
    Valencia, 46010, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05264311
Lead sponsor
University of Valencia
Responsible party
Marco Romagnoli (Principal Investigator, University of Valencia) — Principal investigator
First posted
Mar 3, 2022
Start date
Jun 1, 2020
Primary completion
Jul 1, 2020
Completion
Jul 2, 2020
Last update
Mar 3, 2022

Study contacts

Ana Ferri-Caruana, PhD
principal investigator · Department of Physical Activity and Sports. University of Valencia

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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