Impact of Pilates and Myofascial Release on Women's Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: self-myofascial release combined reformer Pilates; Other: Reformer Pilates

• Registration Number: NCT06425744
• Lead Sponsor: Sahmyook University

Brief Summary

The aim of this study is to find out if Reformer Pilates and self-myofascial release are effective for pain and muscle function in women with chronic low back pain. Investigators will also look at changes in quality of life. The main questions for the study are

Can Reformer Pilates and self-myofascial release reduce pain in participants? Can Reformer Pilates and self-myofascial release change muscle function in participants? The researchers want to compare the effects of Reformer Pilates and self-myofascial release in women with chronic low back pain.

Participants will be

Group 1 Perform Reformer Pilates and self-myofascial release exercises twice a week for 6 weeks, for a total of 12 sessions.

Group 2 Perform Reformer Pilates exercises twice a week for 6 weeks, for a total of 12 sessions.

Participants will visit the Pilates Centre for an examination before and once after starting the programme.

All groups perform a home exercise training programme for 15 minutes three times a week.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-08
• Primary Completion: 2022-10-30
• Study Completion: 2022-11-05
• Status Verified: 2024-05
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

• People who have had chronic low back pain for 12 weeks or more
• Have a Korean Oswestry Disability Index (KODI) score of 17% or higher

Exclusion Criteria

• Patients with low back pain due to trauma, neurological lesions of the lower extremities, herniated disc lesions, hip, pelvic or abdominal surgery
• Patients who have received radiation or injections within the last 3 months,
• Pregnant women or patients who have given birth within the last year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental 1 group	self-myofascial release combined reformer Pilates	The experimental 1 group perform self-myofascial release and Pilates exercises.
experimental 2 group	Reformer Pilates	The experimental 2 group perform pilates exercise using reformer.

Primary Outcome Measures

Name	Time	Method
Pain severity	From enrollment to the end of treatment at 6 weeks	Pain severity is measured using a visual analogue scale, where participants mark the level of back pain they feel on a line between 0 mm and 100 mm(0: no pain, 10: worst pain imaginable).; Measurement unit is in mm, with higher scores considered more painful
Functional disability caused by low back pain	From enrollment to the end of treatment at 6 weeks	The Korean version of the Oswestry Disability Index (KODI) is used to assess functional impairment due to low back pain. This assessment consists of 10 items, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual life, social life, and travel, with each item scored on a scale of 0 to 5 for a total of 50 points. The KODI score is given as a percentage (%) of the total score. Scores are categorised as mild disability (0-20%), moderate disability (21-40%), severe disability (40-60%) and disability affecting all aspects of life (\>60%), with high test-retest reliability (r=0.92).

Secondary Outcome Measures

Name	Time	Method
Quality of life questionnaire	From enrollment to the end of treatment at 6 weeks	The European Quality of Life 5-Dimensional 5-Level Version (EQ-5D-5L) questionnaire is used to assess quality of life. This standardised tool assesses five dimensions: mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression. General health status is measured using a visual analogue scale (EQ-5D VAS). Scores on the EQ-5D index range from -0.59 to 1, with 1 being the best health. In the absence of a scoring algorithm, a summed scale score was also calculated for both versions to provide additional information about the contribution of the two additional 5L response categories.
Flexibility of lower back and hamstring	From enrollment to the end of treatment at 6 weeks	Flexibility is measured using the sit-to-stand reach test (SRT), which assesses the flexibility of the lower back and hamstrings. The score is the most distant point (cm) reached with the fingertips. The best of three trials should be recorded. Participants sit with their feet on a box, knees straight, and reach as far forward as possible. The posture is maintained for five seconds and the reach distance is recorded over three trials and averaged. The longer the distance in centimeters, the more flexible it is.
Muscular endurance	From enrollment to the end of treatment at 6 weeks	Muscular endurance is assessed using the supine bridge test (SBT), which requires participants to raise their pelvis to form a straight line from shoulder to knee. The time taken to hold the position is recorded in seconds (sec) and averaged over three trials. The longer time hold is the higher muscular endurance.

Trial Locations

Locations (1)

Pilates Dasom; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of