Clinical trial NCT06351267: Combined Effects of Core Stability Exercises and Back Strengthening Exercises on Pregnancy-Induced Back Pain.
Official title: Combined Effects of Core Stability Exercises and Back Strengthening Exercises on Pregnancy-Induced Back Pain, Disability and Function.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be a Randomized controlled trial to check the combined effects of Core Stability Exercises with and without Back strengthening exercises in females with pregnancy-induced back pain, disability, and function so that we can examine the effect of the above techniques on pain, disability and function in pregnant females Non-probability convenience sampling technique will be used, subject following eligibility criteria from Society Hospital Nabipura Lahore will be randomly allocated in two groups. Group A participants will be given core stability exercises with back strengthening exercises, Group B participants will be given core stability exercises for 4 weeks. Assessment will be done via, Numeric Pain Rating Scale, Oswestry disability index questionnaire and Back pain Functional Scale.

Detailed description: Pregnancy-inducedBack pain causes weakness of abdominal muscles and pelvic muscles which affects core stability and back strength of pregnant women. In this study, the effects of Core Stability Exercises with and without Back strengthening exercises in pregnancy-induced back pain population will be analyzed. This study will be a randomized controlled trial. Core stability exercises and Strengthening exercises program would be applied to pregnant females with pregnancy-induced back pain. Subjects meeting the predetermined inclusion criteria will be divided into two groups. Assessment will be done using the Numeric Pain Rating Scale (NPRS), Oswestry Disability Index Questionnaire, and Back Pain Functional Scale (BPFS). Subjects in one group will be treated with core stability exercises with back strengthening exercises, and the other will be treated with core stability exercises only. Each subject will receive a total of 20 treatment sessions, with 05 treatment sessions per week. Measurements will be recorded at the start and end of the treatment session. Recorded values will be analyzed for any change using SPSS.

Eligibility criteria: Inclusion Criteria:

* Pregnant females
* Pregnant female in their second and third trimester.
* Multi gravida patient
* Low back pain intensity greater than 4 out of 10 on NPRS, indicating moderate to severe.

Exclusion Criteria:

* Placenta previa
* Bleeding or spotting
* Low back pain before pregnancy
* Pregnancy-induced hypertension
* Pudendal nerve entrapment syndrome.
* Not simultaneously partaking in pelvic floor physical therapy.
* No evoked tenderness upon palpation of levatorani sling at examination.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: up to 4 weeks
measure: Oswestry Disability Index Questionnaire
timeFrame: up to 4 weeks
measure: Back Pain Functional Scale (BPFS):
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Society Hospital Nabipura
state: Punjab
Study officials:
affiliation: Riphah International University, Lahore, Pakistan
name: Marwa Shafiq Dar, MS*
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Katonis P, Kampouroglou A, Aggelopoulos A, Kakavelakis K, Lykoudis S, Makrigiannakis A, Alpantaki K. Pregnancy-related low back pain. Hippokratia. 2011 Jul;15(3):205-10.
citation: Barbier M, Blanc J, Faust C, Baumstarck K, Ranque-Garnier S, Bretelle F. Standardized Stretching Postural postures to treat low-back pain in pregnancy: the GEMALODO randomized clinical trial. Am J Obstet Gynecol MFM. 2023 Oct;5(10):101087. doi: 10.1016/j.ajogmf.2023.101087. Epub 2023 Jul 11.