NCT06133985

Brief Summary

The aim of this randomized controlled trial is to determine the effectiveness of costovertebral joint mobilization on lung function in asthmatics. By targeting the thoracic region, costovertebral mobilization can play a valuable role in enhancing respiratory function and improving the overall well-being of individuals with respiratory conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

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

October 1, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

October 25, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

costovertebral joint mobilizationchest tightnessasthmarespiratory function

Outcome Measures

Primary Outcomes (4)

  • Assessment of respiratory function FEV1 using spirometer.

    Spirometry is one of the Pulmonary Function Test; they are useful investigations in the management of patients with respiratory disease or respiratory weakness secondary to neurological impairment. Spirometry will measure FEV1

    3 weeks

  • Assessment of respiratory function FVC using spirometer.

    Spirometry is one of the Pulmonary Function Test; they are useful investigations in the management of patients with respiratory disease or respiratory weakness secondary to neurological impairment. Spirometry will measure FVC

    3 weeks

  • Tape for chest expansion

    Chest expansion is measured using a measuring tape at 2 different levels of the rib cage. The 2 measurements of chest diameter are taken at the end of deep inspiratory and expiratory maneuvers. Upper and lower chest expansion are obtained by subtracting the inspiratory diameter from the expiratory diameter, according to the designated anatomical markers. The assessment is performed 1 measurement of upper chest expansion and then 1 measurement of the lower chest expansion consecutively, holding the measuring tape at both ends with thumb and index finger around the patient body.

    3 weeks

  • Dyspnea index

    It is used to describe their sense of breathlessness and breathing problem, and the effects of their breathing on their lives.

    3 weeks

Study Arms (2)

Costovertebral mobilizations + Conventional Physiotherapy

EXPERIMENTAL

Costovertebral mobilizations along conventional treatment patient would receive costovertebral mobilization in side lying position for 10th to 6th ribs, in sitting position for 10th to 2nd rib and in supine position for 1 rib. Frequency: 5 times/week for 3 weeks. Intensity: moderate intensity (pain free) Time: 20 mins Type: costovertebral joint mobilization to improve respiratory function and chest tightness. Conventional treatment diaphragmatic breathing exercises and pursed-lip expiration exercises. Patient will receive diaphragmatic breathing and pursed lip breathing exercise in sitting position Frequency: 5 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 30 mins Type: breathing exercises to improve respiratory function and chest tightness.

Other: Costovertebral mobilizations + Conventional PT

Conventional Physiotherapy

OTHER

diaphragmatic breathing exercises and pursed-lip expiration exercises Patient will receive diaphragmatic breathing and pursed lip breathing exercise in sitting position Frequency: 5 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 20 mins Type: breathing exercises to improve respiratory function and chest tightness.

Other: Conventional treatment

Interventions

Costovertebral mobilizations along conventional treatment patient would receive costovertebral mobilization in side lying position for 10th to 6th ribs, in sitting position for 10th to 2nd rib and in supine position for 1 rib. Frequency: 5 times/week for 3 weeks. Intensity: moderate intensity (pain free) Time: 10 mins Type: costovertebral joint mobilization to improve respiratory function and chest tightness. Conventional treatment diaphragmatic breathing exercises pursed-lip expiration exercises. Patient will receive diaphragmatic breathing and pursed lip breathing exercise in sitting position Frequency: 5 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 20 mins Type: breathing exercises to improve respiratory function and chest tightness.

Costovertebral mobilizations + Conventional Physiotherapy

diaphragmatic breathing exercises pursed-lip expiration exercises. Patient will receive diaphragmatic breathing and pursed lip breathing exercise in sitting position Frequency: 5 times/week for 3 weeks Intensity: moderate intensity (pain free) Time: 20 mins Type: breathing exercises to improve respiratory function and chest tightness.

Conventional Physiotherapy

Eligibility Criteria

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

You may qualify if:

  • Force Expiratory Volume 1/Force Vital Capacity ratio less than 0.7
  • Mild asthma (Force Expiratory Volume 1 over 70% predicted)
  • Chest tightness (inspiratory muscle tightness)
  • Altered Dyspnea index.

You may not qualify if:

  • presence of any underlying lung condition other than asthma.
  • significant cardiovascular or musculoskeletal disease that may compromise the participant's capacity to participate in physical activity;
  • active cancer.
  • uncontrolled hypertension or diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rahim Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

AsthmaRespiratory Aspiration

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Asghar Khan, DPT,DSc PT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2023

First Posted

November 18, 2023

Study Start

October 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations