Pilates in Women With Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Back Pain, Low
• Interventions: Other: Pilates exercise program

• Registration Number: NCT05264311
• Lead Sponsor: University of Valencia

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.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-02
• Status Verified: 2022-02
• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-21
• Last Update Submitted: 2022-02-21
• Study First Posted: 2022-03-03
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EG: Exercise Group	Pilates exercise program	Pilates exercise program (1 h x 2 sessions per week x 2 months)

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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	LBOS was measured at pre-intervention (T0) and pos-intervention (T8).
A 10-cm Visual Analog Scale (VAS) was used to evaluate pain intensity	2 months	VAS was measured at pre-intervention (T0) and pos-intervention (T8).
Full TFRoM was calculated as the average TFRoM from the three flexion-extension tasks.	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.

Trial Locations

Locations (1)

Faculty of Physical Activity and Sport Sciences. University of Valencia; 🇪🇸 Valencia, Spain