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Effects of Upper Back Strengthening and Postural Correction in Pregnant Females With Costal Rib Pain

Primary Purpose

Chest Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Upper back strengthening and Postural correction
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Pain

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Avicenna HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Upper back strengthening and Postural correction:

Control group:

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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
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.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
May 10, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05834166
Brief Title
Effects of Upper Back Strengthening and Postural Correction in Pregnant Females With Costal Rib Pain
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Upper back strengthening and Postural correction:
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group:
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Upper back strengthening and Postural correction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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
Time Frame
up to 4 weeks
Title
Patient Specific Functional Scale
Description
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
Time Frame
up to 4 weeks
Title
Pittsburgh Sleep Quality Index
Description
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.
Time Frame
up to 4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghulam Fatima, PhD*
Phone
03034073057
Email
ghulam.fatima@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD*
Phone
051-5481826
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nayab Naina, MS*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avicenna Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghulam Fatima, PhD*
Phone
03034073057
Email
ghulam.fatima@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30515249
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.
Results Reference
background
PubMed Identifier
30991911
Citation
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.
Results Reference
background
PubMed Identifier
28678599
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.
Results Reference
background
PubMed Identifier
28593100
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.
Results Reference
background
PubMed Identifier
27008303
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.
Results Reference
background
PubMed Identifier
25905714
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.
Results Reference
background
PubMed Identifier
24396221
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.
Results Reference
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Effects of Upper Back Strengthening and Postural Correction in Pregnant Females With Costal Rib Pain

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