Chronic Neck PainNCT05588765
Effects of Respiratory Muscle Training on Pulmonary Function
A study testing Neck stretching exercises in people with Chronic Neck Pain, run by University of Lahore at 1 site in Pakistan.
Trial summary
The study was conducted to determine the effects of respiratory muscle training on pulmonary function and musculoskeletal parameters in patients with chronic neck pain. It included 43 patients, 20-40 years old males and females having non-specific chronic neck pain for more than three months and with low maximum… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Neck stretching exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2019to 31 Aug 2019
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- . Patients having non-specific chronic neck pain with or without headache for more than three months with pain complaints at least once a week 2. Males and females both of age 20 to 40 years old 3. Patients with low maximum voluntary ventilation (MVV) values i.e., less than 110 L/min in males and 80 L/min in females
Who cannot join
- Patients already participating in physiotherapy program 2. Patients with past history of
- surgery to the cervical spine
- traumatic cervical injuries
- clinical abnormalities or surgeries of the thoracic cage or vertebral column
- severe obesity (BMI>40)
- pregnancy
Show all 9Show fewer
- smoking history/occupational industrial exposures
- chronic neuro-musculoskeletal pain in any other non-related body area
- respiratory or cardiac illness, diabetes mellitus and serious comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Respiratory Muscle Training on Pulmonary Function of Patients With Chronic Neck Pain
The study was conducted to determine the effects of respiratory muscle training on pulmonary function and musculoskeletal parameters in patients with chronic neck pain. It included 43 patients, 20-40 years old males and females having non-specific chronic neck pain for more than three months and with low maximum voluntary ventilation (MVV) values were included. Control group (n=21) received conventional physiotherapy with diaphragmatic breathing exercises and experimental group (n=23) received conventional physiotherapy with specially designed respiratory exercise protocol. It concluded that RMT in addition to conventional physiotherapy is effective to improve musculoskeletal and pulmonary parameters in CNP patients.
Read the detailed description
To determine the effects of respiratory muscle training on pulmonary function and musculoskeletal parameters in patients with chronic neck pain.
Study design: A randomized controlled trial Place and Duration of Study: Riphah Rehabilitation and Research Center in Railway General Hospital and Benazir Bhutto Hospital, Rawalpindi from January 2019 to July 2019.
Methodology: 43 patients, 20-40 years old males and females having non-specific chronic neck pain for more than three months and with low maximum voluntary ventilation (MVV) values were included. Control group (n=21) received conventional physiotherapy with diaphragmatic breathing exercises and experimental group (n=23) received conventional physiotherapy with specially designed respiratory exercise protocol. They were assessed prior to, at 2nd week and after 4 weeks of treatment.
- Conditions
- Chronic Neck Pain
- Being tested
- Neck stretching exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck stretching exercisesOther
Neck stretching exercises towards lateral flexion, ipsilateral flexion and rotation and towards flexion each for 30 sec and repeated 2-3 times
| Study group | Role | What they receive |
|---|---|---|
| Respiratory muscle endurance training | Experimental | Volume oriented incentive spirometer improves respiratory muscle endurance and chest expansion. Receives: Other: Neck stretching exercises |
| Diaphragmatic breathing exercises | Active comparator | Improvement in diaphragm contraction, chest wall symmetry and reduce activity of accessory muscle due to diaphragmatic breathing technique causes respiratory muscle endurance to improve. Receives: Other: Neck stretching exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Pulmonary Function
Determines possible obstruction or restriction is present in patients suspect-able to lung dysfunction
Measured: Baseline and 4 weeks
Change from baseline in Cloth tape measurement technique
Cloth tape measurement technique is used as an outcome measure for chest expansion in management of cardio respiratory conditions.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Mar 2019
- Primary completion31 Jul 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Collaborators
- Riphah International University
- Responsible party
- Principal investigator, Madeeha Shafiq, University of Lahore
- Investigators
- Suman Sheraz, PHD*, Principal investigator, Suman.sheraz@riphah.edu.pk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588765
- Sponsor's protocol ID
- REC/00534
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Respiratory Muscle Training on Pulmonary Function of Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT05588765
- Acronym / sponsor ID
- REC/00534
- Conditions
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Collaborators
- Riphah International University
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 20 Oct 2022 (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.
The study was conducted to determine the effects of respiratory muscle training on pulmonary function and musculoskeletal parameters in patients with chronic neck pain. It included 43 patients, 20-40 years old males and females having non-specific chronic neck pain for more than three months and with low maximum voluntary ventilation (MVV) values were included. Control group (n=21) received conventional physiotherapy with diaphragmatic breathing exercises and experimental group (n=23) received conventional physiotherapy with specially designed respiratory exercise protocol. It concluded that RMT in addition to conventional physiotherapy is effective to improve musculoskeletal and pulmonary parameters in CNP patients.
Detailed description
To determine the effects of respiratory muscle training on pulmonary function and musculoskeletal parameters in patients with chronic neck pain.
Study design: A randomized controlled trial Place and Duration of Study: Riphah Rehabilitation and Research Center in Railway General Hospital and Benazir Bhutto Hospital, Rawalpindi from January 2019 to July 2019.
Methodology: 43 patients, 20-40 years old males and females having non-specific chronic neck pain for more than three months and with low maximum voluntary ventilation (MVV) values were included. Control group (n=21) received conventional physiotherapy with diaphragmatic breathing exercises and experimental group (n=23) received conventional physiotherapy with specially designed respiratory exercise protocol. They were assessed prior to, at 2nd week and after 4 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Respiratory muscle endurance training | Experimental | Other: Neck stretching exercisesVolume oriented incentive spirometer improves respiratory muscle endurance and chest expansion. |
| Diaphragmatic breathing exercises | Active comparator | Other: Neck stretching exercisesImprovement in diaphragm contraction, chest wall symmetry and reduce activity of accessory muscle due to diaphragmatic breathing technique causes respiratory muscle endurance to improve. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- . Patients having non-specific chronic neck pain with or without headache for more than three months with pain complaints at least once a week 2. Males and females both of age 20 to 40 years old 3. Patients with low maximum voluntary ventilation (MVV) values i.e., less than 110 L/min in males and 80 L/min in females
Key exclusion criteria (9 listed)
- Patients already participating in physiotherapy program 2. Patients with past history of
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 |
|---|---|---|
| Neck stretching exercisesNeck stretching exercises towards lateral flexion, ipsilateral flexion and rotation and towards flexion each for 30 sec and repeated 2-3 times | Other | Diaphragmatic breathing exercises, Respiratory muscle endurance training |
Primary outcome
Change from baseline in Pulmonary Function
Time frame: Baseline and 4 weeks
Determines possible obstruction or restriction is present in patients suspect-able to lung dysfunction
Change from baseline in Cloth tape measurement technique
Time frame: Baseline and 4 weeks
Cloth tape measurement technique is used as an outcome measure for chest expansion in management of cardio respiratory conditions.
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 20 Oct 2022.
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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.
Suman Sheraz, PHD* principal investigator
Suman.sheraz@riphah.edu.pk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neck stretching exercises in people with Chronic Neck Pain, run by University of Lahore 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 1 inclusion and 9 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 20 Oct 2022. 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?
Change from baseline in Pulmonary Function (time frame: Baseline and 4 weeks). The study lists 2 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 20 Oct 2022.