Pilates in Women With Chronic Low Back Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain, Low
• Intervention / Treatment: Other: Pilates exercise program

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EG: Exercise Group; Pilates exercise program (1 h x 2 sessions per week x 2 months)	Other: Pilates 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.; Other Names: Core strength exercise program
No Intervention: CG: Control Group; Usual lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months
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).	2 months
A 10-cm Visual Analog Scale (VAS) was used to evaluate pain intensity	VAS was measured at pre-intervention (T0) and pos-intervention (T8).	2 months

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Principal Investigator: Ana Ferri-Caruana, PhD, Department of Physical Activity and Sports. University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 2, 2020

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: UV-INV_ETICA-1292671

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No