NCT05588765

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

October 3, 2022

Last Update Submit

October 18, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in Pulmonary Function

    Determines possible obstruction or restriction is present in patients suspect-able to lung dysfunction

    Baseline and 4 weeks

  • 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.

    Baseline and 4 weeks

Study Arms (2)

Respiratory muscle endurance training

EXPERIMENTAL

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

Other: Neck stretching exercises

Diaphragmatic breathing exercises

ACTIVE COMPARATOR

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

Other: Neck stretching exercises

Interventions

Neck stretching exercises towards lateral flexion, ipsilateral flexion and rotation and towards flexion each for 30 sec and repeated 2-3 times

Diaphragmatic breathing exercisesRespiratory muscle endurance training

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suman

Islamabad, 00430, Pakistan

Location

Study Officials

  • Suman Sheraz, PHD*

    Suman.sheraz@riphah.edu.pk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Seal Envelope method
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 20, 2022

Study Start

March 1, 2019

Primary Completion

July 31, 2019

Study Completion

August 31, 2019

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations