Skip to main content
OpenTrials
Completed

NCT Number: NCT05264311

Pilates in Women With Chronic Low Back Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Back Pain, Low Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Activity and Sport Sciences. University of Valencia

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pilates exercise program

Other

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.

Other names: Core strength exercise program

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.

    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

  1. Full TFRoM was calculated as the average TFRoM from the three flexion-extension tasks.

    Time frame: 2 months

    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.

  2. The version adapted to the Spanish population of the Low Back Outcome Score (LBOS) questionnaire was used to measure self-reported functional capacity.

    Time frame: 2 months

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

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

    Time frame: 2 months

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

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2022
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.