NCT06736145

Brief Summary

The aim of this work is to record changes on accessory muscles especially sternocleidomastoid and scalene after applying cervical NAGs in COPD patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

12 months

First QC Date

June 12, 2024

Last Update Submit

December 12, 2024

Conditions

COPD

Keywords

Airflow Obstruction, ChronicChronic Airflow ObstructionChronic Obstructive Airway DiseaseChronic Obstructive Pulmonary DiseaseChronic Obstructive Lung DiseaseCOPDCOAD

Outcome Measures

Primary Outcomes (2)

  • Tape Line

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

    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.

    3rd week

Secondary Outcomes (2)

  • Dyspnea Index

    3rd week

  • Tampa Scale of Kinesiophobia

    3rd week

Study Arms (2)

Traditional Physical Therapy

ACTIVE COMPARATOR

Cervical stretches and inspiratory muscle training

Other: Traditional Physical Therapy

Mulligan Glides

EXPERIMENTAL

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

Other: Mulligan Glides

Interventions

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.

Traditional Physical Therapy
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.

Mulligan Glides

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan institute of medical sciences

Islamabad, Federal, 04485, Pakistan

RECRUITING

Related Publications (10)

  • 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.

    PMID: 31151892BACKGROUND

  • 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.

    PMID: 31740261BACKGROUND

  • 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.

    PMID: 32964724BACKGROUND

  • 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.

    PMID: 29212834BACKGROUND

  • 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.

    PMID: 27683840BACKGROUND

  • 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.

    PMID: 36412608BACKGROUND

  • 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.

    PMID: 33937131BACKGROUND

  • 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.

    PMID: 35497375BACKGROUND

  • 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.

    PMID: 25311596BACKGROUND

  • 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.

    PMID: 26982455BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Asmar Fatima, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmar Fatima, MS-OMPT

CONTACT

03336195644asmar.fatima@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2024

First Posted

December 16, 2024

Study Start

May 1, 2024

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

December 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)