Clinical trial NCT05355246: Effects of Assisted Sit-up Exercise vs Swiss Ball Pikes on Postpartum Low Back Pain.
Official title: Effects of Assisted Sit-up Exercise Versus Swiss Ball Pikes on Pain and Disability in Patients With Postpartum Low Back Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Disorder
Lumbar Pain Syndrome
Activation, Patient
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 21
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study will be a randomized clinical trial. Subjects with postpartum low back pain meeting the predetermined inclusion and exclusion criteria will divide into two groups. Pre-assessment will be done using the Numeric Pain Rating Scale \& Roland-Morris Questionnaire as subjective measurements. Subjects in one group will be treated with assisted sit-up exercise and the other will be treated with swiss ball pikes. Each subject will receive a total of 12 treatment sessions, with 2 treatment sessions per week. Post-treatment reading for numeric pain rating scale and Roland-Morris questionnaire will be recorded after the end of the 4th, 8th, and 12th treatment session.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Numeric pain rating scale (NPRS)
timeFrame: up to 6 weeks
measure: Ronald Morris Disability (RMD) questionnaire
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bahawalpur
country: Pakistan
facility: Victoria Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Ghulam Fatima, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Rathore Vs. effect of swiss ball training on breath holding capacity of male physical education students.
citation: 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.
citation: 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.
citation: 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.