ClinicalTrials.gg
CompletedNCT05355246Updated Apr 3, 2023

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

An interventional study of assisted sit-up exercises and swiss ball pikes exercises in Postpartum Disorder, Lumbar Pain Syndrome and Activation, Patient, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-04-03.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Postpartum Disorder
  • Lumbar Pain Syndrome
  • Activation, Patient
03

In context

Puerperal Disorders

40 studies on the registry are indexed under Puerperal Disorders; 10 are open to participants now.

This study's enrollment of 21 is below the median of 81 across 32 interventional studies indexed under Puerperal Disorders.

Browse Puerperal Disorders studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Any kind of infection, , 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    assisted sit-up exercises Group

    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

  • Active comparator
    swiss ball pikes exercises Group

    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

  • Otherassisted sit-up exercises

    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.

  • Otherswiss ball pikes exercises

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 6 weeks

  2. 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.

    Time frame: up to 6 weeks

07

Study locations

1 site
  • Victoria Hospital
    Bahawalpur, Punjab 54700, Pakistan
08

References and documents

Publications

  • 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. PubMed 31852228 ↗
  • 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. PubMed 29995793 ↗
  • 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. PubMed 31864910 ↗
  • 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. PubMed 31016337 ↗
  • 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. PubMed 32011431 ↗
  • Rathore Vs. effect of swiss ball training on breath holding capacity of male physical education students.
  • 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. PubMed 29889057 ↗
  • 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. PubMed 20436242 ↗
  • 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. PubMed 32227774 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2022 to primary completion in Oct 2022, 6 months.

Of 20 interventional studies with no phase under Puerperal Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2022
First posted
May 2, 2022
StartActual
Apr 27, 2022
Primary completionActual
Oct 30, 2022
CompletionActual
Nov 30, 2022
Last update
Apr 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05355246
Responsible party
Sponsor
First posted
May 2, 2022
Start date
Apr 27, 2022
Primary completion
Oct 30, 2022
Completion
Nov 30, 2022
Last update
Apr 3, 2023

Study contacts

Ghulam Fatima, PhD*
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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