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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05397899
Other study ID # RiphahIU Asma Bhatti
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date December 31, 2022

Study information

Verified date February 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

literature suggests the use of hypopressive abdominal techniques to be effective in increasing the thickness of the abdominal muscles and hence add to the stability of the spine and alleviation of low back pain in the postpartum period. This will be a randomized controlled trial, with two groups. Participants in the experimental group will learn how to perform the "hypopressive maneuver", which 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. control group will perform general exercises. Both groups will be assessed at pre and post test (after 6weeks)


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date December 31, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Postpartum non-radiating low back Pain - LBP severity >3 on numeric pain rating scale (NPRS) - Spontaneous vaginal delivery Exclusion Criteria: - Prenatal history of low back pain - Caesarean section - Hypertension - Puerperium period - Arterial complications - Neurological deficit - Disc Bulge - Lumbar Radiculopathy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Abdominal hypopressive Exercises (AHE)
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.
General exercises
General exercises are therapeutic exercises for core muscles for the treatment of postpartum low back pain.

Locations

Country Name City State
Pakistan Holy Family Hospital Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & 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. Erratum In: Evid Based Complement Alternat Med. 2018 Sep 6;2018:3601984. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Oswestry Low Back Pain Disability Index(ODI) The Oswestry Low Back Pain Disability Index is a validated, 10-point patient-reported outcome questionnaire. It is considered the 'gold standard for measuring disability and quality of life (QoL) impairment for adults with low back pain. The Cronbach-a for the ODI is 0.75. The ODI showed excellent test- retest reliability (intraclass correlation coefficient = 0.91) Changes from Baseline to 6th week
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