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Effect of First Rib Mobilization With Balloon Breathing Exercises

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
First rib mobilization with balloon breathing exercises
Sponsored by
Sehat Medical Complex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age group 18-45 years Gender: Male, Female Patients with non-specific chronic neck pain referred by physician or orthopedic surgeon Computer users, mobile users and those with routine of prolonged sitting Exclusion Criteria: Any H/o neurological or vestibular disorders. Any H/o Cervical Trauma or surgery Any history of Physiotherapy treatment for the cervical region within the previous three months cardiac or respiratory insufficiency Pregnancy Neoplasm

Sites / Locations

  • Sehat Medical Complex, Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional treatment group

First rib mobilization with balloon breathing exercises group

Arm Description

Hot pack and TENS at neck for 10minutes. Therapeutic ultrasound for 5 minutes Soft tissue techniques (gliding and kneading) was applied at a slow speed for 5 minutes over the neck muscles. Gentle stretching and strengthening exercises

Patient was in supine position, placing the soles of his feet against the wall so that the ankle, knee, and thigh joints are at a 90-degree angle. The subject placed a 3-4-inch ball between his/her knees, which he/she has to maintain through the pressure of the internal thigh muscles during the whole training period and puts his/her back on the bed. Holds the right hand above the head and the left hand with the balloon. Meanwhile examiner palpated 1st rib with head in left side flexion. Patient was then asked to inhale through the nose in three-four seconds and then exhales slowly into the balloon. Then, holding the first rib in place, the patient was asked to inhale and exhale deeply again. The examiner continued applying pressure to hold the first rib in a position of relative depression during inhalation, and further depress the first rib as able during exhalation.

Outcomes

Primary Outcome Measures

Neck Disability Index (change is being assessed)
Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. 0-4points (0-8%) no disability, 5-14points ( 10 - 28%) mild disability, 15-24points (30-48% ) moderate disability, 25-34points (50- 64%) severe disability, 35-50points (70-100%) complete disability
Numeric Pain Rating Scale (change is being assessed)
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"
Single Breath Count (change is being assessed)
Participants will be requested to count out loud after maximal inspiration. The ability to reach a count of 50 is considered as normal respiratory function
Chest Wall Expansion (change is being assessed)
Take an inches tape and encircle chest around the level of nipple. Take measurements at the end of deep inspiration and expiration. Normally, a 2-5" of chest expansion can be observed

Secondary Outcome Measures

Full Information

First Posted
February 7, 2023
Last Updated
August 26, 2023
Sponsor
Sehat Medical Complex
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1. Study Identification

Unique Protocol Identification Number
NCT05732246
Brief Title
Effect of First Rib Mobilization With Balloon Breathing Exercises
Official Title
Effect of First Rib Mobilization With Balloon Breathing Exercises in Non Specific Chronic Neck Pain: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
August 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sehat Medical Complex

4. Oversight

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

5. Study Description

Brief Summary
As Non specific chronic neck pain is effecting quality of life in many ways, there are many studies evaluating the methods to treat that problem. This study aims to determine Effect of first rib mobilization with balloon breathing exercises in non specific chronic neck pain. Patients would be divided into two groups and both received conventional treatment. Group A got conventional treatment only but Group B got 1st rib mobilization with balloon breathing exercises in addition.
Detailed Description
Nonspecific chronic neck pain (NSCNP) is defined as neck pain persisting for longer than 12 weeks or after the healing period or recurring neck pain that intermittently affects an individual over a long time. Due to current life style, 22 to 70% of the population is expected to feel neck pain somewhere in their lives. People with non-specific chronic neck pain (NSCNP) present with local hyperalgesia, impaired conditioned pain modulation, low quality of life, and psychological disruptions (fear of movement, depressive symptoms, pain catastrophizing) A systematic review and meta-analysis on Respiratory dysfunction in patients with chronic neck pain reports that, patients with Chronic Neck Pain have reduced respiratory muscle strength and pulmonary function compared with asymptomatic individuals, and this difference could be clinically meaningful. As previous studies provides evidence about effect of MWM on non specific chronic neck pain and also states relation of breathing dysfunction in NSCNP so we aim to determine effect of first rib mobilization with balloon breathing exercise in addition to conventional treatment in non specific chronic neck pain. Patients would be divided into two groups and both received conventional treatment. Group A got conventional treatment only but Group B got 1st rib mobilization with balloon breathing exercises in addition.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional treatment group
Arm Type
No Intervention
Arm Description
Hot pack and TENS at neck for 10minutes. Therapeutic ultrasound for 5 minutes Soft tissue techniques (gliding and kneading) was applied at a slow speed for 5 minutes over the neck muscles. Gentle stretching and strengthening exercises
Arm Title
First rib mobilization with balloon breathing exercises group
Arm Type
Experimental
Arm Description
Patient was in supine position, placing the soles of his feet against the wall so that the ankle, knee, and thigh joints are at a 90-degree angle. The subject placed a 3-4-inch ball between his/her knees, which he/she has to maintain through the pressure of the internal thigh muscles during the whole training period and puts his/her back on the bed. Holds the right hand above the head and the left hand with the balloon. Meanwhile examiner palpated 1st rib with head in left side flexion. Patient was then asked to inhale through the nose in three-four seconds and then exhales slowly into the balloon. Then, holding the first rib in place, the patient was asked to inhale and exhale deeply again. The examiner continued applying pressure to hold the first rib in a position of relative depression during inhalation, and further depress the first rib as able during exhalation.
Intervention Type
Other
Intervention Name(s)
First rib mobilization with balloon breathing exercises
Intervention Description
Patient was in the supine position, placing the soles of his feet against the wall so that the ankle, knee, and thigh joints are at a 90-degree angle. The subject placed a 3-4-inch ball between his/her knees, which he/she has to maintain through the pressure of the internal thigh muscles during the whole training period and puts his/her back on the bed. Holds the right hand above the head and the left hand with the balloon. Meanwhile examiner would palpate 1st rib with head in left side flexion. Patient was then asked to inhale through the nose in three-four seconds and then exhales slowly into the balloon. Then, holding the first rib in place, the patient was asked to inhale and exhale deeply again. The examiner continued applying pressure to hold the first rib in a position of relative depression during inhalation, and further depressed the first rib as able during exhalation.
Primary Outcome Measure Information:
Title
Neck Disability Index (change is being assessed)
Description
Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. 0-4points (0-8%) no disability, 5-14points ( 10 - 28%) mild disability, 15-24points (30-48% ) moderate disability, 25-34points (50- 64%) severe disability, 35-50points (70-100%) complete disability
Time Frame
Change from Baseline measures at 8 weeks
Title
Numeric Pain Rating Scale (change is being assessed)
Description
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"
Time Frame
Change from Baseline measures at 8 weeks
Title
Single Breath Count (change is being assessed)
Description
Participants will be requested to count out loud after maximal inspiration. The ability to reach a count of 50 is considered as normal respiratory function
Time Frame
Change from Baseline measures at 8 weeks
Title
Chest Wall Expansion (change is being assessed)
Description
Take an inches tape and encircle chest around the level of nipple. Take measurements at the end of deep inspiration and expiration. Normally, a 2-5" of chest expansion can be observed
Time Frame
Change from Baseline measures at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age group 18-45 years Gender: Male, Female Patients with non-specific chronic neck pain referred by physician or orthopedic surgeon Computer users, mobile users and those with routine of prolonged sitting Exclusion Criteria: Any H/o neurological or vestibular disorders. Any H/o Cervical Trauma or surgery Any history of Physiotherapy treatment for the cervical region within the previous three months cardiac or respiratory insufficiency Pregnancy Neoplasm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feroza Nawaz, MSOMPT
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sehat Medical Complex, Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
55201
Country
Pakistan

12. IPD Sharing Statement

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Effect of First Rib Mobilization With Balloon Breathing Exercises

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