NCT05342181

Brief Summary

To compare the effects of static exercises with dynamic core stability on pain and disability in postpartum back pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

1 month

First QC Date

February 20, 2022

Last Update Submit

April 15, 2022

Conditions

Back Pain

Keywords

Pain and disability in postpartum

Outcome Measures

Primary Outcomes (2)

  • Oswestry disability index

    Oswestry disability index (ODI) is used to measure disability. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.

    4th week

  • visual analog scale

    Visual analog scale (VAS) is usd to measure pain intensity. The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.

    4th week

Study Arms (2)

Static exercises

EXPERIMENTAL

static exercises i.e traditional exercises along with base line treatment of TENS and hot pack

Other: Static exercises

Dynamic exercises

EXPERIMENTAL

dynamic (Swiss ball) exercises along with base line treatment of TENS and hot pack

Other: Dynamic exercises

Interventions

Static exercisesOTHER

Participants will be treated with static core muscle exercises that are traditional group of exercises : 1. supine bridge 2. plank 3. oblique crunch 4. side lying with Abduction This program includes static exercises performed thrice a week for 4 weeks.This exercise comprises 5 minutes warm up and slight stretching.Rest time of 2-3 minutes with proper stretching in between sets of activity. Subjects will be requested to undertake cool down exercises, which include aerobic workouts followed by stretching exercises, at the end of each day's exercise programme. Before beginning the next session's training, the subjects will be asked if they had any discomfort.

Static exercises
Dynamic exercisesOTHER

Participants will be treated with dynamic core muscle exercises that were swiss ball exercises 1. bridging 2. straight leg raise in prone lying 3. straight leg raise with hand raise in prone lying 4. pelvic tilts This program includes static exercises performed thrice a week for 4 weeks.This exercise comprises 5 minutes warm up and slight stretching.Rest time of 2-3 minutes with proper stretching in between sets of activity. Subjects will be requested to undertake cool down exercises, which include aerobic workouts followed by stretching exercises, at the end of each day's exercise programme. Before beginning the next session's training, the subjects will be asked if they had any discomfort.

Dynamic exercises

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAge groups of 18 to 35 Without referred pain to lower limbs Women with normal delivery
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age groups of 18 to 35
  • Pain more than 4/10 on VAS
  • Without referred pain to lower limbs
  • Women with normal delivery

You may not qualify if:

  • Nulliparous women
  • Osteoporosis and OA
  • Systemic arterial hypertension
  • Hypersensitivity to electrical modalities
  • Any fracture (spine, rib) or injury
  • Any abdominal surgery
  • Any other general ailment
  • Vertebral or disc pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Back PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sara Aabroo, pp-dpt

    General hospital lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

April 22, 2022

Study Start

September 21, 2021

Primary Completion

October 25, 2021

Study Completion

November 14, 2021

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)