| CTRI Number |
CTRI/2025/07/091881 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
“Improving Lung Function in COPD Patients: Comparing Joint Manipulation and Chest Physiotherapy” |
|
Scientific Title of Study
|
EFFECT OF 3 WEEKS JOINT MANIPULATION VERSUS CONVENTIONAL CHEST PHYSIOTHERAPY ON CHEST EXPANSION AND PULMONARY FUNCTION AMONG CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) PATIENTS WITHIN VADODARA– ANEXPERIMENTAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Silvi Bajaj |
| Designation |
PG Scholar |
| Affiliation |
Drs Kiran and Pallavi Patel Global university |
| Address |
Cardio respiratory department, Drs. Kiran and Pallavi Global University, Vadodara-Mumbai National Highway 8, Vadodara, Gujarat
Cardio respiratory department, Drs. Kiran and Pallavi Global University, Vadodara-Mumbai National Highway 8, Vadodara, Gujarat
Vadodara
GUJARAT
391240
India |
| Phone |
8320065964 |
| Fax |
|
| Email |
silvibajaj41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shreya Trivedi (PT) |
| Designation |
Assistant professor |
| Affiliation |
Drs Kiran and Pallavi Patel Global university |
| Address |
Krishna School of Physiotherapy & Rehabilitation, KPGU Krishna Edu Campus, Varnama, Vadodara
Krishna School of Physiotherapy & Rehabilitation, KPGU Krishna Edu Campus, Varnama, Vadodara
Vadodara
GUJARAT
391240
India |
| Phone |
9428639469 |
| Fax |
|
| Email |
shreyatrivedi.kspr@kpgu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Silvi Bajaj |
| Designation |
PG Scholar |
| Affiliation |
Drs Kiran and Pallavi Patel Global university |
| Address |
Cardio respiratory department, Drs. Kiran and Pallavi Global University, Vadodara-Mumbai National Highway 8, Vadodara, Gujarat
Cardio respiratory department, Drs. Kiran and Pallavi Global University, Vadodara-Mumbai National Highway 8, Vadodara, Gujarat
Vadodara
GUJARAT
391240
India |
| Phone |
8320065964 |
| Fax |
|
| Email |
silvibajaj41@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Silvi Bajaj |
| Address |
Bajaj Bhavan ghee kanta road soarathiya street kodinar gir somnath |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Silvi Bajaj |
Pranayam Lung & Heart Institute – Multispeciality Hospital |
Department of Physiotherapy, First Floor, Pranayam Lung & Heart Institute, New VIP Road, Vadodara, Gujarat, India – 390022
Vadodara
GUJARAT |
8320065964
silvibajaj41@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Chest Physiotherapy |
Patients will receive Diaphragmatic Breathing exercise and Thoracic mobility exercise without Joint Manipulation. Therapy will be provided 10 repetitions/set, 3 set/day, 3 days/week for 3 weeks. Outcomes measured will include PFT and chest wall expansion. |
| Intervention |
Joint Manipulation with conventional Chest Physiotherapy |
Patients will receive Diaphragmatic Breathing Exercise, Thoracic mobility exercise and Joint Manipulation. Joint Manipulation will be done in a prone position and 1 thrust at one level per day 3 days per week for 3 weeks. The Technique is performed for Thoracic spine T1-T10 in posteroanterior caudal and lateral directions. Pulmonary Function Test and chest wall expansion will be measured before and after intervention. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with chronic obstructive pulmonary disease (COPD) based on GOLD-stage classification of obstructive pulmonary disease severity to be included in the study.
Both male and female participations aged between 35 and 65 years. |
|
| ExclusionCriteria |
| Details |
Patients with any other cardiorespiratory conditions
Patients with neurological, musculoskeletal and metabolic conditions
Presence of tumors
Acute exacerbations of COPD
Recent thoracoabdominal surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Forced Expiratory Volume in one second, Forced Vital Capacity ratio, Chest Expansion |
At baseline (pre-intervention) and after 3 weeks (post-intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="21" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This experimental study aims to compare the effectiveness of Joint Manipulation versus Conventional Chest Physiotherapy on Chest Expansion and Pulmonary function among Chronic Obstructive Pulmonary Disease (COPD) patients within Vadodara. A total of 36 patients aged 35 to 65, diagnosed with COPD, will be recruited and randomly allocated into two groups. Group A will receive Conventional Chest Physiotherapy and group B will receive Conventional Chest Physiotherapy with Joint Manipulation for thoracic spine (T1-T10). Group A will be treated with 10 repetitions/set, 3 set/day, 3 days/week for 3 weeks and Group B will be treated with 1 thrust at one level / day, 3 days/week for 3 weeks. Outcome measures including Chest Expansion and Pulmonary Function Test (FEV1/FVC). The intervention aims to improve Lung Function, Chest Expansion and Quality of life in COPD patients. |