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NCT Number: NCT06351267

Combined Effects of Core Stability Exercises and Back Strengthening Exercises on Pregnancy-Induced Back Pain.

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Society Hospital Nabipura

Lahore, Punjab Province, 54700, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Core Stability Exercises

Other

Core stability exercises will be used to strengthen the core muscles, which includes sets of exercises like pelvic tilts, wall squatting, bridging, bird dog and heel walking which targets core muscles.

Back Strengthening exercises

Other

Back strengthening exercises will be used to strengthen the back muscles which include sets of exercises that target back muscles like cat-cow exercise, child pose, heel sits, and kegels.

Primary outcomes

  1. Numeric Pain Rating Scale

    Time frame: up to 4 weeks

    The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes. changes from Baseline to 4 week

  2. Oswestry Disability Index Questionnaire

    Time frame: up to 4 weeks

    The Oswestry disability index questionnaire gives subjective percentage score of level of function(disability) in activities of daily living in those rehabilitating from low back pain with level of disability in 10 everyday activities. Each item consists of 6 options with score 0-5. With 0 indicating least disability and 5 greater then total score will be calculated as percentage. 0% indicating no disability and 100% highest level of disability.

  3. Back Pain Functional Scale (BPFS):

    Time frame: up to 4 weeks

    The BPFS is a subjective scale used to measure the patient physical function after low back pain. It consists of 12 items and total score of 60. The maximum score indicates maximum physical abilities of patient. 0 being no physical abilities and 60 being no difficulty in any activity

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Combined Effects of Core Stability Exercises and Back Strengthening Exercises on Pregnancy-Induced Back Pain, Disability and Function.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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