Pilates in Women With Chronic Low Back Pain

NCT05264311 | Completed

• 1 other identifier: UV-INV_ETICA-1292671
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain, Low

Outcome Measures

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.

  2 months

Secondary Outcomes (3)

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

  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.

  2 months

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

  2 months

Study Arms (2)

EG: Exercise Group

EXPERIMENTAL

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

Other: Pilates exercise program

CG: Control Group

NO INTERVENTION

Usual lifestyle

Interventions

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.

Also known as: Core strength exercise program

EG: Exercise Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Physical Activity and Sport Sciences. University of Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Ana Ferri-Caruana, PhD

  Department of Physical Activity and Sports. University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 3, 2022
• Study Start: June 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 2, 2020
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)