ClinicalTrials.gg
RecruitingNCT06736145Updated Dec 16, 2024

Cervical Nags Effect on Accessory Muscles

An interventional study of Traditional Physical Therapy and Mulligan Glides in COPD, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-12-16.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started May 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • COPD

Keywords

  • Airflow Obstruction, Chronic
  • Chronic Airflow Obstruction
  • Chronic Obstructive Airway Disease
  • Chronic Obstructive Pulmonary Disease
  • Chronic Obstructive Lung Disease
  • COPD
  • COAD
03

In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's planned enrollment of 36 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,176 studies on the registry; 637 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (estimated)

Study arms

  • Active comparator
    Traditional Physical Therapy

    Cervical stretches and inspiratory muscle training

    Other: Traditional Physical Therapy

  • Experimental
    Mulligan Glides

    Mulligan Natural Apophyseal Glides along with cervical stretches and inspiratory muscle training

    Other: Mulligan Glides

Interventions

  • OtherTraditional Physical Therapy

    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.

  • OtherMulligan Glides

    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.

06

What researchers measure

Primary outcomes

  1. Tape Line

    Changes from baseline ROM range of motion for cervical flexion,etension, lateral flexion and rotation is measured using tape

    Time frame: 3rd week

  2. 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.

    Time frame: 3rd week

Secondary outcomes

  1. 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.

    Time frame: 3rd week

  2. 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.

    Time frame: 3rd week

07

Study locations

1 of 1 sites recruiting
  • Pakistan institute of medical sciences
    Islamabad, Federal 04485, Pakistan
    Recruiting
08

References and documents

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 31151892 ↗
  • Corlateanu 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 31740261 ↗
  • Agusti 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 32964724 ↗
  • Brandsma 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 29212834 ↗
  • Cardoso 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 27683840 ↗
  • Shiraishi 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 36412608 ↗
  • Ahmadipoor 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 33937131 ↗
  • Tanaka 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 35497375 ↗
  • Gartner-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 25311596 ↗
  • Rosa 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Apr 2025, 11 months after the start.

Of 796 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 11 months is below that.

Counting every sponsor, half of 848 studies reached it within 24 months; a quarter within 11 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2024
First posted
Dec 16, 2024
StartActual
May 1, 2024
Primary completionEst.
Apr 30, 2025
CompletionEst.
Apr 30, 2025
Last update
Dec 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06736145
Responsible party
Sponsor
First posted
Dec 16, 2024
Start date
May 1, 2024
Primary completion
Apr 30, 2025 (estimated)
Completion
Apr 30, 2025 (estimated)
Last update
Dec 16, 2024

Study contacts

Asmar Fatima, MS-OMPT
Contact
asmar.fatima@riphah.edu.pk
03336195644
Asmar Fatima, MSOMPT
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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