Clinical trial NCT05264311: Pilates in Women With Chronic Low Back Pain
Official title: Effect of a Pilates Exercise Program on the Flexion-relaxation Rate in Women With Chronic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain, Low
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 2 months
Secondary outcomes:
measure: Full TFRoM was calculated as the average TFRoM from the three flexion-extension tasks.
timeFrame: 2 months
measure: The version adapted to the Spanish population of the Low Back Outcome Score (LBOS) questionnaire was used to measure self-reported functional capacity.
timeFrame: 2 months
measure: A 10-cm Visual Analog Scale (VAS) was used to evaluate pain intensity
timeFrame: 2 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physical Activity and Sport Sciences. University of Valencia
Study officials:
affiliation: Department of Physical Activity and Sports. University of Valencia
name: Ana Ferri-Caruana, PhD
role: PRINCIPAL_INVESTIGATOR
References: