Neck PainNCT05732246
Effect of First Rib Mobilization With Balloon Breathing Exercises
A study testing First rib mobilization with balloon breathing exercises in people with Neck Pain, run by Sehat Medical Complex at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- First rib mobilization with balloon breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Feb 2023to 24 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of First Rib Mobilization With Balloon Breathing Exercises in Non Specific Chronic Neck Pain: A Randomized Control Trial
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.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- First rib mobilization with balloon breathing exercises
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First rib mobilization with balloon breathing exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment group | No intervention | 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 |
| First rib mobilization with balloon breathing exercises group | Experimental | 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. Receives: Other: First rib mobilization with balloon breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline measures at 8 weeks
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"
Measured: Change from Baseline measures at 8 weeks
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
Measured: Change from Baseline measures at 8 weeks
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
Measured: Change from Baseline measures at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start6 Feb 2023
- Primary completion30 Jun 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehat Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waseem Javaid, Sehat Medical Complex
- Investigators
- Feroza Nawaz, MSOMPT, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732246
- Sponsor's protocol ID
- ferozanawaz15
- Status last verified
- Aug 2023
- First submitted
- 7 Feb 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of First Rib Mobilization With Balloon Breathing Exercises in Non Specific Chronic Neck Pain: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05732246
- Acronym / sponsor ID
- ferozanawaz15
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sehat Medical ComplexUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment group | No intervention | –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 |
| First rib mobilization with balloon breathing exercises group | Experimental | Other: First rib mobilization with balloon breathing exercisesPatient 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First rib mobilization with balloon breathing exercisesPatient 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. | Other | First rib mobilization with balloon breathing exercises group |
Primary outcome
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
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"
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feroza Nawaz, MSOMPT principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First rib mobilization with balloon breathing exercises in people with Neck Pain, run by Sehat Medical Complex at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Disability Index (change is being assessed) (time frame: Change from Baseline measures at 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.