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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05834166
Other study ID # REC/RCR & AHS/23/0524
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date September 15, 2023

Study information

Verified date March 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

1. Study will be a Non-Randomized clinical trial to check the 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 so that we can devise a treatment protocol for females during pregnancy suffering from costal rib pain. Duration of study was 6 months, Non-probability convenient sampling technique was used, subject following eligibility criteria from Avicenna Hospital were allocated in two groups, baseline assessment was done, Group A participants were given baseline treatment along with upper back strengthening and postural correction exercises, Group B participants were given baseline treatment along with no other specific treatment for 3 weeks. On 6th and 12th day, post intervention assessment was done via, Numeric Pain Rating Scale, Patient Specific Functional Scale and Pittsburgh Sleep Quality Index. 3 sessions per week were given, data was analyzed by using SPSS version 26.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date September 15, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Upper back strengthening and Postural correction
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.

Locations

Country Name City State
Pakistan Avicenna Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Pain Rating Scale 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 up to 4 weeks
Primary Patient Specific Functional Scale 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 up to 4 weeks
Primary Pittsburgh Sleep Quality Index 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. up to 4 weeks
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