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Effects of Trunk Stabilization Versus Activation Exercises on Pain and Disability in Postpartum Lumbo-pelvic Pain (LPP)

Primary Purpose

Pelvic Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Trunk stabilization
Activation exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain focused on measuring Lumbo-pelvic Pain, Postpartum, Stabilization Exercises, Trunk Activation Exercises

Eligibility Criteria

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

Inclusion Criteria:

  • Age 20-40
  • Female after postpartum
  • Two or more positive posterior provocation test
  • Active straight leg raises
  • Pain onset during pregnancy

Exclusion Criteria:

  • Orthopedic or rheumatologic disorders
  • Intervertebral disc pathology
  • Neoplasm or previuos surgery of spine
  • History of fracture.

Sites / Locations

  • Jinnah hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Trunk stabilization

Activation exercises

Arm Description

Trunk stabilization exercises were given three times a week for two weeks.

Activation exercises exercises performed twice for 5s, with 2 min rest between them for three times a week for two weeks.

Outcomes

Primary Outcome Measures

Visual analogue scale
Pain intensity was assessed using a visual analog scale (VAS), which is a 100-mm ungraded line with two anchors. Its left and right anchors represented the minimum and maximum intensities of pain, respectively. The participants were asked to report their current pain intensity on the VAS.

Secondary Outcome Measures

Oswestry disability index
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools.

Full Information

First Posted
August 4, 2022
Last Updated
December 7, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05490810
Brief Title
Effects of Trunk Stabilization Versus Activation Exercises on Pain and Disability in Postpartum Lumbo-pelvic Pain
Acronym
LPP
Official Title
Effects of Trunk Stabilization Versus Activation Exercises on Pain and Disability in Postpartum Lumbo-pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
July 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
To compare the Effects of trunk stabilization versus activation exercises on pain and disability in postpartum lumbo-pelvic pain.
Detailed Description
Effects of stabilizing exercises on postpartum pelvic floor muscle function, lumbo-pelvic pain and disability. In results, stability exercises can help women with LPP enhance the function of their PFMs. Pregnancy and childbirth weakens PFMs and disrupts the load-transfer system in the lumbo-pelvic area. The use of PFMs in the right pattern can help these muscles operate better. Local stabilizing muscles are targeted during stabilization exercises, which increase pelvic motor control and stability. As per researcher knowledge there was limited evidence present on the comparison of trunk stabilization and trunk activation exercises. Therefore, this study was conducted to find the effectiveness of trunk stabilization versus activation exercises on disability and pain in postpartum women with lumbo-pelvic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain
Keywords
Lumbo-pelvic Pain, Postpartum, Stabilization Exercises, Trunk Activation Exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trunk stabilization
Arm Type
Experimental
Arm Description
Trunk stabilization exercises were given three times a week for two weeks.
Arm Title
Activation exercises
Arm Type
Experimental
Arm Description
Activation exercises exercises performed twice for 5s, with 2 min rest between them for three times a week for two weeks.
Intervention Type
Other
Intervention Name(s)
Trunk stabilization
Intervention Description
Trunk stabilization exercises with Static back: A roll of towel was pressed against the back and the position was held for 10 secs and then released Static gluteus: The gluts were pressed inside and hold for 10 secs and then released. Abdominal bracing: Brace your abdomen by contracting your entire abdomen. From here Perform different exercises such as raising your arms and then raising your legs. Pelvic bridging: In crook lying, engage your gluts and trunk lift your hips towards the ceiling. Hold the position for 10 secs and then release. SLR with-hold at 30 and 45 degrees: Ask the supine patient to raise the leg up-to 45 degrees and hold for 10 secs. Then raise the leg up-to 30 degrees then hold for 10 secs.
Intervention Type
Other
Intervention Name(s)
Activation exercises
Intervention Description
Activation exercises with Upper rectus abdominis (URA) and lower rectus abdominis (LRA): body supine with hips and knees flexed 90°, with feet locked. Participants flexed the trunk (i.e. crunch execution) against resistance at the level of the shoulders.. External oblique (EO) and internal oblique (IO): side-lying with the hip at the edge of the bench and feet locked by a second operator. Participants performed side-bend exercise against resistance at the level of the shoulder. Lower erector spinae (LES) and upper erector spinae (UES): prone position with ASIS at the edge of the bench and feet locked by a second operator. Participants performed a back extension against resistance at the level of the shoulders.
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
Pain intensity was assessed using a visual analog scale (VAS), which is a 100-mm ungraded line with two anchors. Its left and right anchors represented the minimum and maximum intensities of pain, respectively. The participants were asked to report their current pain intensity on the VAS.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Oswestry disability index
Description
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools.
Time Frame
2 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20-40 Female after postpartum Two or more positive posterior provocation test Active straight leg raises Pain onset during pregnancy Exclusion Criteria: Orthopedic or rheumatologic disorders Intervertebral disc pathology Neoplasm or previuos surgery of spine History of fracture.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Neelam Muneeb, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Trunk Stabilization Versus Activation Exercises on Pain and Disability in Postpartum Lumbo-pelvic Pain

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