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Effects of Respiratory Muscle Training on Pulmonary Function

Primary Purpose

Chronic Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Neck stretching exercises
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • . 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

Exclusion Criteria:

  • 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
    • 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

Sites / Locations

  • Suman

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Respiratory muscle endurance training

Diaphragmatic breathing exercises

Arm Description

Volume oriented incentive spirometer improves respiratory muscle endurance and chest expansion.

Improvement in diaphragm contraction, chest wall symmetry and reduce activity of accessory muscle due to diaphragmatic breathing technique causes respiratory muscle endurance to improve.

Outcomes

Primary Outcome Measures

Change from baseline in Pulmonary Function
Determines possible obstruction or restriction is present in patients suspect-able to lung dysfunction
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.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2022
Last Updated
October 18, 2022
Sponsor
University of Lahore
Collaborators
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05588765
Brief Title
Effects of Respiratory Muscle Training on Pulmonary Function
Official Title
Effects of Respiratory Muscle Training on Pulmonary Function of Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore
Collaborators
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized Control Trial
Masking
Participant
Masking Description
Seal Envelope method
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Respiratory muscle endurance training
Arm Type
Experimental
Arm Description
Volume oriented incentive spirometer improves respiratory muscle endurance and chest expansion.
Arm Title
Diaphragmatic breathing exercises
Arm Type
Active Comparator
Arm Description
Improvement in diaphragm contraction, chest wall symmetry and reduce activity of accessory muscle due to diaphragmatic breathing technique causes respiratory muscle endurance to improve.
Intervention Type
Other
Intervention Name(s)
Neck stretching exercises
Intervention Description
Neck stretching exercises towards lateral flexion, ipsilateral flexion and rotation and towards flexion each for 30 sec and repeated 2-3 times
Primary Outcome Measure Information:
Title
Change from baseline in Pulmonary Function
Description
Determines possible obstruction or restriction is present in patients suspect-able to lung dysfunction
Time Frame
Baseline and 4 weeks
Title
Change from baseline in Cloth tape measurement technique
Description
Cloth tape measurement technique is used as an outcome measure for chest expansion in management of cardio respiratory conditions.
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: . 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suman Sheraz, PHD*
Organizational Affiliation
Suman.sheraz@riphah.edu.pk
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suman
City
Islamabad
ZIP/Postal Code
00430
Country
Pakistan

12. IPD Sharing Statement

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Effects of Respiratory Muscle Training on Pulmonary Function

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