Pilates in Women With Chronic Low Back Pain

Back Pain, Low Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05264311
• Other study ID #: UV-INV_ETICA-1292671
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: July 2, 2020

Study information

• Verified date: February 2022
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Back Pain, Low
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
Spain	Faculty of Physical Activity and Sport Sciences. University of Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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