NCT05397899

Brief Summary

Postpartum Low back pain (PP-LBP) is more common and can lead to limitations to women's daily activity. Pregnancy related low back pain has been reported to occur in 55% to 78% women worldwide.This study is planned to determine the effects of abdominal hypopressive technique on postpartum low back pain, mobility and disability.

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 Jun 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

May 25, 2022

Last Update Submit

February 20, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale (NPRS)

    The pain score was assessed using the numeric pain rating scale (NPRS) is a scoring system, wherein the pain level was quantified on a scale of 0 (no pain) to 10 (worst possible pain). The NPRS is a valid and frequently employed method of musculoskeletal pain assessment.

    Changes from Baseline to 6th week

  • Pregnancy Mobility Index

    It is self-report mobility scale designed specifically for the pregnant women. The internal consistency (Cronbach's alpha) is 0.8 or higher indicating a good construct validity. The assumptions that the Pregnancy Mobility Index scores increase during pregnancy and decrease after delivery and that women with back or pelvic problems scored higher on the Pregnancy Mobility Index domains than women without back or pelvic pain were confirmed, indicating a good criterion validation. Its scores range from 0 to 100, in which 0 equals 'normal performance' and 100 indicates 'maximum disability

    Changes from Baseline to 6th week

  • Maternal Postpartum Quality of Life Index

    It is a sixteen-item scale, which is a valid and reliable instrument for postpartum QOL assessment. It includes items on the different aspects of postpartum QOL and can be used for the early diagnosis of impaired postpartum QOL. The QoL score ranges from 0 to 30, with higher scores indicating higher QoL.

    Changes from Baseline to 6th week

Secondary Outcomes (1)

  • Oswestry Low Back Pain Disability Index(ODI)

    Changes from Baseline to 6th week

Study Arms (2)

AHT group

EXPERIMENTAL

This group will receive Abdominal hypopressive exercises. Each AHT will be repeated 3-5 times with 1 min rest between exercises (shift to new posture, lying,sitting and standing). Between 6 and 15 hypopressive exercises (HEs) will be performed within each session based on the participant's mastery of the exercises and readiness to progress, for 6 weeks.

Other: Abdominal hypopressive Exercises (AHE)

General exercise group

ACTIVE COMPARATOR

This group will receive general exercises (Bridging, knee to chest, Straight leg rise) these will be repeated 3-5 times with 1 min rest between exercises. Between 6 and 15 repetitions will be performed within each session based on the participant's mastery of the exercises and readiness to progress. Each exercise to be repeated 3-5 times per set, and participants will be asked to perform technique once daily for 6 weeks

Other: General exercises

Interventions

Active and specific Therapeutic exercises will be used to treat postpartum low back pain in this study. AHE consisted of exhaling to their expiratory reserve volume, then holding their breath (apnea), and expanding their rib cage, to draw their abdominal wall inward and cranially without inhalation. Each exercise will have a specific frequency, intensity, and duration.

AHT group

General exercises are therapeutic exercises for core muscles for the treatment of postpartum low back pain.

General exercise group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Postpartum non-radiating low back Pain
  • LBP severity \>3 on numeric pain rating scale (NPRS)
  • Spontaneous vaginal delivery

You may not qualify if:

  • Prenatal history of low back pain
  • Caesarean section
  • Hypertension
  • Puerperium period
  • Arterial complications
  • Neurological deficit
  • Disc Bulge
  • Lumbar Radiculopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holy Family Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (6)

  • Bellido-Fernandez L, Jimenez-Rejano JJ, Chillon-Martinez R, Gomez-Benitez MA, De-La-Casa-Almeida M, Rebollo-Salas M. Effectiveness of Massage Therapy and Abdominal Hypopressive Gymnastics in Nonspecific Chronic Low Back Pain: A Randomized Controlled Pilot Study. Evid Based Complement Alternat Med. 2018 Feb 22;2018:3684194. doi: 10.1155/2018/3684194. eCollection 2018.

    PMID: 29681973BACKGROUND
  • Saleh MSM, Botla AMM, Elbehary NAM. Effect of core stability exercises on postpartum lumbopelvic pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(2):205-213. doi: 10.3233/BMR-181259.

    PMID: 30282349BACKGROUND
  • Davenport MH, Marchand AA, Mottola MF, Poitras VJ, Gray CE, Jaramillo Garcia A, Barrowman N, Sobierajski F, James M, Meah VL, Skow RJ, Riske L, Nuspl M, Nagpal TS, Courbalay A, Slater LG, Adamo KB, Davies GA, Barakat R, Ruchat SM. Exercise for the prevention and treatment of low back, pelvic girdle and lumbopelvic pain during pregnancy: a systematic review and meta-analysis. Br J Sports Med. 2019 Jan;53(2):90-98. doi: 10.1136/bjsports-2018-099400. Epub 2018 Oct 18.

    PMID: 30337344BACKGROUND
  • Da Cuna-Carrera I, Alonso-Calvete A, Soto-Gonzalez M, Lantaron-Caeiro EM. How Do the Abdominal Muscles Change during Hypopressive Exercise? Medicina (Kaunas). 2021 Jul 9;57(7):702. doi: 10.3390/medicina57070702.

    PMID: 34356983BACKGROUND
  • Juez L, Nunez-Cordoba JM, Couso N, Auba M, Alcazar JL, Minguez JA. Hypopressive technique versus pelvic floor muscle training for postpartum pelvic floor rehabilitation: A prospective cohort study. Neurourol Urodyn. 2019 Sep;38(7):1924-1931. doi: 10.1002/nau.24094. Epub 2019 Jul 11.

    PMID: 31297874BACKGROUND
  • Soriano L, Gonzalez-Millan C, Alvarez Saez MM, Curbelo R, Carmona L. Effect of an abdominal hypopressive technique programme on pelvic floor muscle tone and urinary incontinence in women: a randomised crossover trial. Physiotherapy. 2020 Sep;108:37-44. doi: 10.1016/j.physio.2020.02.004. Epub 2020 Feb 19.

    PMID: 32707289BACKGROUND

Study Officials

  • Huma Riaz, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
outcome assessor will be kept blind about the group of patients and treatment received.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This will be a Pretest-Postest Control group Design with parallel assignment of patients into two groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

May 31, 2022

Study Start

June 1, 2022

Primary Completion

November 30, 2022

Study Completion

December 31, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations