- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05732246
Effect of First Rib Mobilization With Balloon Breathing Exercises
Effect of First Rib Mobilization With Balloon Breathing Exercises in Non Specific Chronic Neck Pain: A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 55201
- Sehat Medical Complex, Lahore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Conventional treatment group
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 |
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|
Experimental: First rib mobilization with balloon breathing exercises group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index (change is being assessed)
Time Frame: Change from Baseline measures at 8 weeks
|
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
|
Change from Baseline measures at 8 weeks
|
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Numeric Pain Rating Scale (change is being assessed)
Time Frame: Change from Baseline measures at 8 weeks
|
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"
|
Change from Baseline measures at 8 weeks
|
|
Single Breath Count (change is being assessed)
Time Frame: Change from Baseline measures at 8 weeks
|
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
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Change from Baseline measures at 8 weeks
|
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Chest Wall Expansion (change is being assessed)
Time Frame: Change from Baseline measures at 8 weeks
|
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 |
Change from Baseline measures at 8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Feroza Nawaz, MSOMPT, University of Lahore
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
- ferozanawaz15
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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