COPDNCT06736145
Cervical Nags Effect on Accessory Muscles
A study testing Traditional Physical Therapy and Mulligan Glides in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this work is to record changes on accessory muscles especially sternocleidomastoid and scalene after applying cervical NAGs in COPD patients. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- COPD
- What is being tested?
- Traditional Physical Therapy and Mulligan Glides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Registered with history of moderate (II) to severe (III) grade COPD (for a minimum of 1 year) will be included in the study.
- Patients who are clinically stable.
Who cannot join
- Patients who have any pre-existing cervical spine disease.
- Patients who have any cardiac disease.
- Other respiratory co-morbidities
- Patients who have severe dizziness or coughing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan institute of medical sciences
Islamabad, Federal, 04485
Asmar Fatima, MSOMPT, 03336195644, asmar.fatima@riphah.edu.pk
Ghaniya Khan, MS_OMPT*, +92 332 1554725, ghaniyakhan147@gmail.com
About this study
Official title: Effects of Cervical Nags on Accessory Muscles in Patients With Copd
The aim of this work is to record changes on accessory muscles especially sternocleidomastoid and scalene after applying cervical NAGs in COPD patients.
Read the detailed description
Natural gliding movements in the spine, known as apophyseal glides, occur during breathing. These movements are believed to be important for maintaining good posture and flexibility in the spine. In COPD patients, the muscles that support the spine, like the scalene and SCM, can become tight and strained due to labored breathing. This tightness can lead to neck and shoulder pain.
While studies suggest that natural apophyseal glides improve spinal mobility, accessory muscle flexibility and reduce pain, there is room for further research on COPD patients, especially in Pakistan.
- Conditions
- COPD
- Being tested
- Traditional Physical Therapy, Mulligan Glides
- Keywords
- Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Lung Disease, COPD, COAD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Physical TherapyOther
Diaphragmatic, Pursed Lip breathing and Targeted cervical muscle stretches 10 repetitions x 1 set, 3 days/week
Total of 9 sessions were given each consisting of 40 mins.
Mulligan GlidesOther
Natural Apophyseal Glides of Cervical spine are given 3 repetitions x 3-6 sets, 3 days/week.
Diaphragmatic, Pursed Lip breathing and Targeted cervical muscle stretches 10 repetitions x 1 set, 3 days/week
Total of 9 sessions were given each consisting of 40 mins.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Physical Therapy | Active comparator | Cervical stretches and inspiratory muscle training Receives: Other: Traditional Physical Therapy |
| Mulligan Glides | Experimental | Mulligan Natural Apophyseal Glides along with cervical stretches and inspiratory muscle training Receives: Other: Mulligan Glides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tape Line
Changes from baseline ROM range of motion for cervical flexion,etension, lateral flexion and rotation is measured using tape
Measured: 3rd week
NPRS
Changes from baseline for pain is measured using NPRS. NPRS stands for Numerical Pain Rating Scale, a common method for assessing pain intensity. It's a simple scale from 0 to 10, where: 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain, 7-10 represents severe pain. Patients are asked to rate their pain by choosing a number on this scale to evaluate and monitor pain levels before and after treatment.
Measured: 3rd week
Secondary outcomes (2)
Dyspnea Index
Changes for baseline for level of Shortness of breath is measured using Dyspnea Index. The dyspnea index, also known as the Modified Medical Research Council (MMRC) scale, measures the severity of breathlessness or dyspnea. It's a 5-point scale: Grade 0: No dyspnea, Grade 1: Dyspnea during strenuous exercise, Grade 2: Dyspnea during moderate exercise, Grade 3: Dyspnea during light exercise or walking on level ground, Grade 4: Dyspnea during daily activities or at rest. This scale helps assess the impact of treatment on copd patients.
Measured: 3rd week
Tampa Scale of Kinesiophobia
Changes from baseline for level of kinesiophobia is measured using Tampa scale. The most widely used scale for assessing kinesiophobia is the Tampa Scale of Kinesiophobia (TSK). This questionnaire contains 17 items that gauge a person's fear of movement and associated with movement. Each item is rated on a 4-point Likert scale, with a higher score indicating a greater degree of kinesiophobia. It has an excellent reliability of Cronbach Alpha > 0.9 (18).
Scores for each item are added together to get a total score. Scores can range from 17 (low kinesiophobia) to 68 (high kinesiophobia). A cut-off score of 37 is often used to indicate high kinesiophobia in COPD patients.
Measured: 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 May 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asmar Fatima, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736145
- Sponsor's protocol ID
- REC/MS-PT/01938 Ghaniya Khan
- Status last verified
- Dec 2024
- First submitted
- 12 Jun 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muhammed A, Moiz JA, Singla D, Ali MS, Talwar D. Postural abnormalities in phenotypes of chronic obstructive pulmonary disease. Braz J Phys Ther. 2020 Jul-Aug;24(4):325-332. doi: 10.1016/j.bjpt.2019.05.002. Epub 2019 May 24.
PubMed 31151892Corlateanu A, Mendez Y, Wang Y, Garnica RJA, Botnaru V, Siafakas N. "Chronic obstructive pulmonary disease and phenotypes: a state-of-the-art.". Pulmonology. 2020 Mar-Apr;26(2):95-100. doi: 10.1016/j.pulmoe.2019.10.006. Epub 2019 Nov 15.
PubMed 31740261Agusti A, Vogelmeier C, Faner R. COPD 2020: changes and challenges. Am J Physiol Lung Cell Mol Physiol. 2020 Nov 1;319(5):L879-L883. doi: 10.1152/ajplung.00429.2020. Epub 2020 Sep 23. No abstract available.
PubMed 32964724Brandsma CA, de Vries M, Costa R, Woldhuis RR, Konigshoff M, Timens W. Lung ageing and COPD: is there a role for ageing in abnormal tissue repair? Eur Respir Rev. 2017 Dec 6;26(146):170073. doi: 10.1183/16000617.0073-2017. Print 2017 Dec 31.
PubMed 29212834Cardoso DM, Fregonezi GA, Jost RT, Gass R, Alberton CL, Albuquerque IM, Paiva DN, Barreto SS. Acute effects of Expiratory Positive Airway Pressure (EPAP) on different levels in ventilation and electrical activity of sternocleidomastoid and parasternal muscles in Chronic Obstructive Pulmonary Disease (COPD) patients: a randomized controlled trial. Braz J Phys Ther. 2016 Nov-Dec;20(6):525-534. doi: 10.1590/bjpt-rbf.2014.0190. Epub 2016 Sep 16.
PubMed 27683840Shiraishi M, Higashimoto Y, Sugiya R, Mizusawa H, Takeda Y, Fujita S, Nishiyama O, Kudo S, Kimura T, Fukuda K, Tohda Y. Sternocleidomastoid Muscle Thickness Correlates with Exercise Tolerance in Patients with COPD. Respiration. 2023;102(1):64-73. doi: 10.1159/000527100. Epub 2022 Nov 22.
PubMed 36412608Ahmadipoor A, Khademi-Kalantari K, Rezasoltani A, Naimi SS, Akbarzadeh-Baghban A. Assessing the Reliability of Echo Intensity of Craniovertebral Muscle Group using B-Mode Ultrasound: A Technical Note. J Biomed Phys Eng. 2021 Apr 1;11(2):257-262. doi: 10.31661/jbpe.v0i0.2009-1182. eCollection 2021 Apr.
PubMed 33937131Tanaka T, Okita M, Jenkins S, Kozu R. Clinical and Psychological Impact of Chronic Pain in People with Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2022 Apr 22;17:893-903. doi: 10.2147/COPD.S359223. eCollection 2022.
PubMed 35497375Gartner-Schmidt JL, Shembel AC, Zullo TG, Rosen CA. Development and validation of the Dyspnea Index (DI): a severity index for upper airway-related dyspnea. J Voice. 2014 Nov;28(6):775-82. doi: 10.1016/j.jvoice.2013.12.017. Epub 2014 Oct 12.
PubMed 25311596Rosa DP, Borstad JD, Pires ED, Camargo PR. Reliability of measuring pectoralis minor muscle resting length in subjects with and without signs of shoulder impingement. Braz J Phys Ther. 2016 Mar 15;20(2):176-83. doi: 10.1590/bjpt-rbf.2014.0146.
PubMed 26982455
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cervical Nags on Accessory Muscles in Patients With Copd
- ClinicalTrials.gov ID
- NCT06736145
- Acronym / sponsor ID
- REC/MS-PT/01938 Ghaniya Khan
- Conditions
- COPD
- Keywords
- Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Pulmonary Disease, Chronic Obstructive Lung Disease, COPD, COAD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 16 Dec 2024 (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 aim of this work is to record changes on accessory muscles especially sternocleidomastoid and scalene after applying cervical NAGs in COPD patients.
Detailed description
Natural gliding movements in the spine, known as apophyseal glides, occur during breathing. These movements are believed to be important for maintaining good posture and flexibility in the spine. In COPD patients, the muscles that support the spine, like the scalene and SCM, can become tight and strained due to labored breathing. This tightness can lead to neck and shoulder pain.
While studies suggest that natural apophyseal glides improve spinal mobility, accessory muscle flexibility and reduce pain, there is room for further research on COPD patients, especially in Pakistan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Physical Therapy | Active comparator | Other: Traditional Physical TherapyCervical stretches and inspiratory muscle training |
| Mulligan Glides | Experimental | Other: Mulligan GlidesMulligan Natural Apophyseal Glides along with cervical stretches and inspiratory muscle training |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Registered with history of moderate (II) to severe (III) grade COPD (for a minimum of 1 year) will be included in the study.
- Patients who are clinically stable.
Key exclusion criteria (4 listed)
- Patients who have any pre-existing cervical spine disease.
- Patients who have any cardiac disease.
- Other respiratory co-morbidities
- Patients who have severe dizziness or coughing
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 |
|---|---|---|
| Traditional Physical TherapyDiaphragmatic, Pursed Lip breathing and Targeted cervical muscle stretches 10 repetitions x 1 set, 3 days/week Total of 9 sessions were given each consisting of 40 mins. | Other | Traditional Physical Therapy |
| Mulligan GlidesNatural Apophyseal Glides of Cervical spine are given 3 repetitions x 3-6 sets, 3 days/week. Diaphragmatic, Pursed Lip breathing and Targeted cervical muscle stretches 10 repetitions x 1 set, 3 days/week Total of 9 sessions were given each consisting of 40 mins. | Other | Mulligan Glides |
Primary outcome
Tape Line
Time frame: 3rd week
Changes from baseline ROM range of motion for cervical flexion,etension, lateral flexion and rotation is measured using tape
NPRS
Time frame: 3rd week
Changes from baseline for pain is measured using NPRS. NPRS stands for Numerical Pain Rating Scale, a common method for assessing pain intensity. It's a simple scale from 0 to 10, where: 0 represents no pain, 1-3 represents mild pain, 4-6 represents moderate pain, 7-10 represents severe pain. Patients are asked to rate their pain by choosing a number on this scale to evaluate and monitor pain levels before and after treatment.
2 secondary outcomes
Dyspnea Index
Time frame: 3rd week
Tampa Scale of Kinesiophobia
Time frame: 3rd week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 31151892Muhammed A, Moiz JA, Singla D, Ali MS, Talwar D. Postural abnormalities in phenotypes of chronic obstructive pulmonary disease. Braz J Phys Ther. 2020 Jul-Aug;24(4):325-332. doi: 10.1016/j.bjpt.2019.05.002. Epub 2019 May 24.
- Background: PubMed 31740261Corlateanu A, Mendez Y, Wang Y, Garnica RJA, Botnaru V, Siafakas N. "Chronic obstructive pulmonary disease and phenotypes: a state-of-the-art.". Pulmonology. 2020 Mar-Apr;26(2):95-100. doi: 10.1016/j.pulmoe.2019.10.006. Epub 2019 Nov 15.
- Background: PubMed 32964724Agusti A, Vogelmeier C, Faner R. COPD 2020: changes and challenges. Am J Physiol Lung Cell Mol Physiol. 2020 Nov 1;319(5):L879-L883. doi: 10.1152/ajplung.00429.2020. Epub 2020 Sep 23. No abstract available.
- Background: PubMed 29212834Brandsma CA, de Vries M, Costa R, Woldhuis RR, Konigshoff M, Timens W. Lung ageing and COPD: is there a role for ageing in abnormal tissue repair? Eur Respir Rev. 2017 Dec 6;26(146):170073. doi: 10.1183/16000617.0073-2017. Print 2017 Dec 31.
- Background: PubMed 27683840Cardoso DM, Fregonezi GA, Jost RT, Gass R, Alberton CL, Albuquerque IM, Paiva DN, Barreto SS. Acute effects of Expiratory Positive Airway Pressure (EPAP) on different levels in ventilation and electrical activity of sternocleidomastoid and parasternal muscles in Chronic Obstructive Pulmonary Disease (COPD) patients: a randomized controlled trial. Braz J Phys Ther. 2016 Nov-Dec;20(6):525-534. doi: 10.1590/bjpt-rbf.2014.0190. Epub 2016 Sep 16.
- Background: PubMed 36412608Shiraishi M, Higashimoto Y, Sugiya R, Mizusawa H, Takeda Y, Fujita S, Nishiyama O, Kudo S, Kimura T, Fukuda K, Tohda Y. Sternocleidomastoid Muscle Thickness Correlates with Exercise Tolerance in Patients with COPD. Respiration. 2023;102(1):64-73. doi: 10.1159/000527100. Epub 2022 Nov 22.
- Background: PubMed 33937131Ahmadipoor A, Khademi-Kalantari K, Rezasoltani A, Naimi SS, Akbarzadeh-Baghban A. Assessing the Reliability of Echo Intensity of Craniovertebral Muscle Group using B-Mode Ultrasound: A Technical Note. J Biomed Phys Eng. 2021 Apr 1;11(2):257-262. doi: 10.31661/jbpe.v0i0.2009-1182. eCollection 2021 Apr.
- Background: PubMed 35497375Tanaka T, Okita M, Jenkins S, Kozu R. Clinical and Psychological Impact of Chronic Pain in People with Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2022 Apr 22;17:893-903. doi: 10.2147/COPD.S359223. eCollection 2022.
- Background: PubMed 25311596Gartner-Schmidt JL, Shembel AC, Zullo TG, Rosen CA. Development and validation of the Dyspnea Index (DI): a severity index for upper airway-related dyspnea. J Voice. 2014 Nov;28(6):775-82. doi: 10.1016/j.jvoice.2013.12.017. Epub 2014 Oct 12.
- Background: PubMed 26982455Rosa DP, Borstad JD, Pires ED, Camargo PR. Reliability of measuring pectoralis minor muscle resting length in subjects with and without signs of shoulder impingement. Braz J Phys Ther. 2016 Mar 15;20(2):176-83. doi: 10.1590/bjpt-rbf.2014.0146.
- Individual participant dataSharing planned: No
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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.
Asmar Fatima, MSOMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Physical Therapy and Mulligan Glides in people with COPD, run by Riphah International University 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 16 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmar Fatima, MS-OMPT (03336195644, asmar.fatima@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tape Line (time frame: 3rd week). 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?
On the ClinicalTrials.gov record for NCT06736145, which also lists 10 linked publications.
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 16 Dec 2024.