- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06736145
Cervical Nags Effect on Accessory Muscles
Effects of Cervical Nags on Accessory Muscles in Patients With Copd
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Asmar Fatima, MS-OMPT
- Phone Number: 03336195644
- Email: asmar.fatima@riphah.edu.pk
Study Locations
-
-
Federal
-
Islamabad, Federal, Pakistan, 04485
- Recruiting
- Pakistan Institute of Medical Sciences
-
Sub-Investigator:
- Asmar Fatima, MS-OMPT
-
Contact:
- Asmar Fatima, MSOMPT
- Phone Number: 03336195644
- Email: asmar.fatima@riphah.edu.pk
-
Contact:
- Ghaniya Khan, MS_OMPT*
- Phone Number: +92 332 1554725
- Email: ghaniyakhan147@gmail.com
-
Principal Investigator:
- Ghaniya Khan, MSOMPT*
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional Physical Therapy
Cervical stretches and inspiratory muscle training
|
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. |
|
Experimental: Mulligan Glides
Mulligan Natural Apophyseal Glides along with cervical stretches and inspiratory muscle training
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3rd week
|
|
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.
|
3rd week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnea Index
Time Frame: 3rd week
|
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.
|
3rd week
|
|
Tampa Scale of Kinesiophobia
Time Frame: 3rd week
|
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. |
3rd week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Asmar Fatima, MSOMPT, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC/MS-PT/01938 Ghaniya Khan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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