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

Primary Purpose

Postpartum Disorder, Lumbar Pain Syndrome, Activation, Patient

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
assisted sit-up exercises
swiss ball pikes exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Disorder

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Victoria Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

assisted sit-up exercises Group

swiss ball pikes exercises Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 21, 2022
Last Updated
March 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05355246
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Disorder, Lumbar Pain Syndrome, Activation, Patient

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
assisted sit-up exercises Group
Arm Type
Experimental
Arm Description
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.
Arm Title
swiss ball pikes exercises Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
assisted sit-up exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
swiss ball pikes exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric pain rating scale (NPRS)
Description
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
Title
Ronald Morris Disability (RMD) questionnaire
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghulam Fatima, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria Hospital
City
Bahawalpur
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31852228
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.
Results Reference
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PubMed Identifier
29995793
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.
Results Reference
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PubMed Identifier
31864910
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.
Results Reference
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PubMed Identifier
31016337
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.
Results Reference
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PubMed Identifier
32011431
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.
Results Reference
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Citation
Rathore Vs. effect of swiss ball training on breath holding capacity of male physical education students.
Results Reference
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PubMed Identifier
29889057
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.
Results Reference
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PubMed Identifier
20436242
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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Effects of Assisted Sit-up Exercise vs Swiss Ball Pikes on Postpartum Low Back Pain.

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