Effects of Assisted Sit-up Exercise vs Swiss Ball Pikes on Postpartum Low Back Pain.

NCT05355246 | Completed

• 1 other identifier: REC/Lhr/22/0503 Romaisa
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate and compare the effectiveness of assisted sit-up exercise and swiss ball pikes on the treatment of pain and disability of postpartum low back pain. The current study will compare the use of assisted sit-up exercise and swiss ball pikes. The current study is novel in a way that there is limited literature about treating postpartum low back pain with physical strengthening exercises. These two methods will be employed to see if they improve ranges along with accompanying pain and disability.

Conditions

Postpartum Disorder; Lumbar Pain Syndrome; Activation, Patient

Outcome Measures

Primary Outcomes (2)

• Numeric pain rating scale (NPRS)

  An outcome measure that is a segmented numeric version of visual analogue scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient's pain. The common format is horizontal bar or line and NPRS is anchored by terms describing pain and severity extremes.

  up to 6 weeks

• Ronald Morris Disability (RMD) questionnaire

  a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. This questionnaire has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain.

  up to 6 weeks

Study Arms (2)

assisted sit-up exercises Group

EXPERIMENTAL

Group A patients will be instructed to perform assisted sit-up exercises by lying on their back and lifting their torso. They will use their body weight to strengthen and tone the core stabilizing abdominal muscles. This exercise will perform a minimum of five and a maximum of 10 repetitions, two times a day and two days a week.

Other: assisted sit-up exercises

swiss ball pikes exercises Group

ACTIVE COMPARATOR

Group B patients will be instructed to perform swiss ball pikes by getting into the pushup position, the rest of the tops of their feet on a swiss ball. Each patient should keep her legs as straight as possible, bend their hips and try to pull their feet towards their chest so that the ball rolls forward. Hold at the top for three to four seconds, then slowly roll back to the starting position. This exercise will perform a minimum of one or two and a maximum of 10 repetitions, two times a day and two days a week. Both exercises will be performed for 12 weeks in both groups.

Other: swiss ball pikes exercises

Interventions

assisted sit-up exercises OTHER

Group A patients will be instructed to perform assisted sit-up exercises by lying on their back and lifting their torso. They will use their body weight to strengthen and tone the core stabilizing abdominal muscles. This exercise will perform a minimum of five and maximum of 10 repetitions, two times a day and two days a week. Isometrics, back stretching, and strengthening exercises will be given as a common intervention for both groups before starting treatment session.

assisted sit-up exercises Group

swiss ball pikes exercises OTHER

Group B patients will be instructed to perform swiss ball pikes by getting into the pushup position, the rest of the tops of their feet on a swiss ball. Each patient should keep her legs as straight as possible, bend her hips and try to pull her feet towards their chest so that the ball rolls forward. Hold at the top for three to four seconds, then slowly roll back to the starting position. This exercise will perform a minimum of one or two and a maximum of 10 repetitions, two times a day and two days a week. Both exercises will be performed for 12 weeks in both groups. Isometrics, back stretching, and strengthening exercises will be given as a common intervention for both groups before starting the treatment session.

swiss ball pikes exercises Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20 to 40 years.
• Back pain without leg pain for at least three months postpartum period.
• Pain intensity of numeric pain rating scale ranges between 6 to 10.
• Intensity of pain limited daily work activities.

You may not qualify if:

• Any kind of infection, malignancy, inflammation, and structural deformity present in the lumbar and pelvic region.
• Neurologic signs
• Trauma history of the lumbar and pelvic region
• Any lumber or abdominal surgery
• Pregnancy.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Victoria Hospital

Bahawalpur, Punjab Province, 54700, Pakistan

Location

Related Publications (9)

• Ha VVA, Zhao Y, Pham MN, Binns CW, Nguyen CL, Nguyen PTH, Chu TK, Lee AH. Physical Activity During Pregnancy and Postpartum Low Back Pain: A Prospective Cohort Study in Vietnam. Asia Pac J Public Health. 2019 Nov;31(8):701-709. doi: 10.1177/1010539519890148.

  PMID: 31852228 BACKGROUND

• Li YP, Cui X, Liu SC, Zhang SH, Zhao YH. Neuromuscular electrical stimulation for treating postpartum low back pain. Medicine (Baltimore). 2018 Jul;97(28):e11426. doi: 10.1097/MD.0000000000011426.

  PMID: 29995793 BACKGROUND

• Tavares P, Barrett J, Hogg-Johnson S, Ho S, Corso M, Batley S, Wishloff K, Weis CA. Prevalence of Low Back Pain, Pelvic Girdle Pain, and Combination Pain in a Postpartum Ontario Population. J Obstet Gynaecol Can. 2020 Apr;42(4):473-480. doi: 10.1016/j.jogc.2019.08.030. Epub 2019 Dec 18.

  PMID: 31864910 BACKGROUND

• Ehsani F, Sahebi N, Shanbehzadeh S, Arab AM, ShahAli S. Stabilization exercise affects function of transverse abdominis and pelvic floor muscles in women with postpartum lumbo-pelvic pain: a double-blinded randomized clinical trial study. Int Urogynecol J. 2020 Jan;31(1):197-204. doi: 10.1007/s00192-019-03877-1. Epub 2019 Apr 23.

  PMID: 31016337 BACKGROUND

• Hu X, Ma M, Zhao X, Sun W, Liu Y, Zheng Z, Xu L. Effects of exercise therapy for pregnancy-related low back pain and pelvic pain: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2020 Jan;99(3):e17318. doi: 10.1097/MD.0000000000017318.

  PMID: 32011431 BACKGROUND

• Rathore Vs. effect of swiss ball training on breath holding capacity of male physical education students.

  BACKGROUND

• Bae CR, Jin Y, Yoon BC, Kim NH, Park KW, Lee SH. Effects of assisted sit-up exercise compared to core stabilization exercise on patients with non-specific low back pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2018;31(5):871-880. doi: 10.3233/BMR-170997.

  PMID: 29889057 BACKGROUND

• Escamilla RF, Lewis C, Bell D, Bramblet G, Daffron J, Lambert S, Pecson A, Imamura R, Paulos L, Andrews JR. Core muscle activation during Swiss ball and traditional abdominal exercises. J Orthop Sports Phys Ther. 2010 May;40(5):265-76. doi: 10.2519/jospt.2010.3073.

  PMID: 20436242 BACKGROUND

• Cheng HY, Carol S, Wu B, Cheng YF. Effect of acupressure on postpartum low back pain, salivary cortisol, physical limitations, and depression: a randomized controlled pilot study. J Tradit Chin Med. 2020 Feb;40(1):128-136.

  PMID: 32227774 BACKGROUND

MeSH Terms

Conditions

Puerperal Disorders; Somatoform Disorders; Patient Participation

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ghulam Fatima, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 2, 2022
• Study Start: April 27, 2022
• Primary Completion: October 30, 2022
• Study Completion: November 30, 2022
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)