- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05834166
Effects of Upper Back Strengthening and Postural Correction in Pregnant Females With Costal Rib Pain
Effects of Upper Back Strengthening and Postural Correction on Pain, Functional Status and Sleep Quality in Females With Costal Rib Pain in 3rd Trimester of Pregnancy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Costal rib pain is very common in pregnancy, especially during the third trimester (weeks 28 to 40). After excluding other serious conditions, this condition can also be diagnosed as intercostal myalgia, costochondritis or muscular strain. There are a lot of causes which can result in costal rib pain such as ribs flaring, hormonal changes, increase in the breast size, inflammation of the ribs cartilage and the stretch on intercostal muscles. It can thus result in pain and discomfort due to which the pregnant females find it difficult to sleep at night and also have functional limitations. The prevalence rate of upper back and costal rib pain in pregnancy is almost 47%. The findings of this study can help physiotherapists to manage the costal rib pain in pregnancy more effectively. This will add valuable knowledge to provide the patients with non-invasive and non-pharmacological options for management of costal rib pain.
There are different structured program with exercises for flexibility, balance and strengthening for the majority of skeletal muscles specifically for the spinal ones, between the 24th and 36th week of pregnancy. Strengthening exercises centered on the trunk reduce pain, improve Quality of life and Physical health in late pregnancy and at two months in the postpartum period. Strengthening exercises also ease the delivery.
Upper back strengthening will involve exercises with light-to-moderate load of free weights (body weight or resistance bands) or with stability ball. Postural correction will involve maintaining the correct posture.
Soft tissue mobilization, chest muscle stretch, trunk muscle stretch and diaphragmatic breathing exercises were incorporated as baseline exercises in both groups.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD*
- Phone Number: 051-5481826
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Ghulam Fatima, PhD*
- Phone Number: 03034073057
- Email: ghulam.fatima@riphah.edu.pk
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54700
- Avicenna Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age : 20-40 years Pregnant females in 3rd trimester
- Positive Painful rib syndrome history(6)
- Primigravida
Exclusion Criteria:
• Tietze syndrome
- Rib Fractures
- Rib tip syndrome
- Slipping Rib Syndrome
- Any recent trauma (last 6 months)
- High Risk pregnancy
- Any bony or soft tissue systemic disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Upper back strengthening and Postural correction:
Group A performed exercises for 3 weeks.
Participants performed upper back strengthening exercises and postural correction exercises for 10 to 15 minutes per session.
All exercises were performed for 3 sessions per week for a period of 4 weeks.
The re-assessment will be done at the 6th and 9th visits.
|
The treatment protocol will involve upper back strengthening exercises and postural correction exercises 3 times a week for 10 to 15 minutes.
Upper back strengthening will involve exercises with light-to-moderate load of free weights (body weight or resistance bands) or with a stability ball.
Postural correction will involve maintaining the correct posture.
|
No Intervention: Control group:
Group B: Group B will receive no intervention.
Baseline treatment will include soft tissue mobilization, chest muscle stretch, trunk muscle stretch, and diaphragmatic breathing exercises for all patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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up to 4 weeks
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Patient Specific Functional Scale
Time Frame: up to 4 weeks
|
The PSFS is an activity specific 10 points scale (0-10) in which an initial assessment and a follow up assessment is done.
Its average score is 4.5.
The rater assigns different activities that are difficult to perform by the patient.
It quantifies the activity limitation and measure the functional outcomes after assessment
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up to 4 weeks
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Pittsburgh Sleep Quality Index
Time Frame: up to 4 weeks
|
The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
The sum of scores for these seven components yields one global score..
A global PSQI score greater than 5 helps to distinguish good and poor sleepers.
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up to 4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nayab Naina, MS*, Riphah International University
Publications and helpful links
General Publications
- Dunn G, Egger MJ, Shaw JM, Yang J, Bardsley T, Powers E, Nygaard IE. Trajectories of lower back, upper back, and pelvic girdle pain during pregnancy and early postpartum in primiparous women. Womens Health (Lond). 2019 Jan-Dec;15:1745506519842757. doi: 10.1177/1745506519842757.
- Kesikburun S, Guzelkucuk U, Fidan U, Demir Y, Ergun A, Tan AK. Musculoskeletal pain and symptoms in pregnancy: a descriptive study. Ther Adv Musculoskelet Dis. 2018 Nov 19;10(12):229-234. doi: 10.1177/1759720X18812449. eCollection 2018 Dec.
- Watelain E, Pinti A, Doya R, Garnier C, Toumi H, Boudet S. Benefits of physical activities centered on the trunk for pregnant women. Phys Sportsmed. 2017 Sep;45(3):293-302. doi: 10.1080/00913847.2017.1351286. Epub 2017 Jul 27.
- Zaruba RA, Wilson E. IMPAIRMENT BASED EXAMINATION AND TREATMENT OF COSTOCHONDRITIS: A CASE SERIES. Int J Sports Phys Ther. 2017 Jun;12(3):458-467.
- Germanovich A, Ferrante FM. Multi-Modal Treatment Approach to Painful Rib Syndrome: Case Series and Review of the Literature. Pain Physician. 2016 Mar;19(3):E465-71.
- Zaremba S, Mueller N, Heisig AM, Shin CH, Jung S, Leffert LR, Bateman BT, Pugsley LJ, Nagasaka Y, Duarte IM, Ecker JL, Eikermann M. Elevated upper body position improves pregnancy-related OSA without impairing sleep quality or sleep architecture early after delivery. Chest. 2015 Oct;148(4):936-944. doi: 10.1378/chest.14-2973.
- Yoo WG. Effect of thoracic stretching, thoracic extension exercise and exercises for cervical and scapular posture on thoracic kyphosis angle and upper thoracic pain. J Phys Ther Sci. 2013 Nov;25(11):1509-10. doi: 10.1589/jpts.25.1509. Epub 2013 Dec 11.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0524
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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