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

NCT06425744 | Completed

• 1 other identifier: SYU 2022-07-014
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

low back pain; Pilates; Myofasical Release; Pain; Flexibility

Outcome Measures

Primary Outcomes (2)

• Pain severity

  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

  From enrollment to the end of treatment at 6 weeks

• Functional disability caused by low back pain

  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).

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (3)

• Flexibility of lower back and hamstring

  From enrollment to the end of treatment at 6 weeks

• Muscular endurance

  From enrollment to the end of treatment at 6 weeks

• Quality of life questionnaire

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

experimental 1 group

ACTIVE COMPARATOR

The experimental 1 group perform self-myofascial release and Pilates exercises.

Other: self-myofascial release combined reformer Pilates

experimental 2 group

ACTIVE COMPARATOR

The experimental 2 group perform pilates exercise using reformer.

Other: Reformer Pilates

Interventions

self-myofascial release combined reformer Pilates OTHER

The self-myofascial release combined reformer Pilates group performs 10 minutes of self-myofascial release using the BALLance© method before beginning 20 minutes of Reformer Pilates. The 6-week program includes warm-up and breathing, main supine exercises 1 and 2, and movements targeting the sacroiliac and hip joints. All Pilates exercises are designed in a variety of positions including supine, prone, sitting and standing. All participants attend twice a week for 6 weeks, for a total of 12 sessions. And all participants performed home exercise program follows the guidelines of Geroge et al (2021) and includes myofascial release and Pilates Reformer exercises, as well as stretching exercises beneficial for chronic low back pain. The home exercises are performed three times a week for 15 minutes, and exercise materials are distributed.

experimental 1 group

Reformer Pilates OTHER

The reformer Pilates group will do 30 minutes of Pilates on the Reformer. All Pilates exercises are designed in a variety of positions including supine, prone, sitting and standing. All participants also attend twice a week for 6 weeks, for a total of 12 sessions. The home exercise program follows the guidelines of Geroge et al (2021) as well as stretching exercises beneficial for chronic low back pain. The home exercises are performed three times a week for 15 minutes, and exercise materials are distributed.

experimental 2 group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahmyook University: lead

Study Sites (1)

Pilates Dasom

Goyang-si, Gyeonggi-do, 10592, South Korea

Location

MeSH Terms

Conditions

Low Back Pain; Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 22, 2024
• Study Start: August 8, 2022
• Primary Completion: October 30, 2022
• Study Completion: November 5, 2022
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)