To compare the Effectiveness of dry cupping therapy with and without thoracic mobilization among low back pain patients:
Design
Randomized Clinical Trials (RCT).
Settings and conduct
4.2: Settings: Lahore Physiotherapy and Rehabilitation Center, Bahria International Hospital, (Lahore).
4.3: Study Duration: Within nine months of the synopsis being approved, the study will be finished.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
● 18–59 years of age (40)
● Both male and female (40)
● If the participant is having pain in the spine for the duration of more than 3 months but not radiating to the leg (28)
● Any participant who has complain of pain on a scale of 3 to 8 (moderate to severe) according to the NPRS (28)
4.6.2: Exclusion Criteria:
● If any participants has planned any flights for the next two months (28)
● Already treated with cupping therapy. (28)
● If any individual is receiving physical therapy interventions (41)
● Any individual with psychological or neurological disorders
● Any individual who are at risk of falls or having visual or auditory discrepancies
● Any participant who can’t receive cupping therapy (e.g. open wound, skin infections) (41)
● Any individual with disorders of spine or spinal cord (e.g. fractures, infection or tumors) (40)
● Sacroiliac joint dysfunctioning
Intervention groups
Participants were randomly allocated into two groups (Group A: Dry cupping therapy group with mobilization, Group B: Dry cupping therapy without mobilization). Both groups received routine physical therapy which includes 15 minutes of heat therapy.
Main outcome variables
1. Pain (Numeric Pain Rating Scale)
2. Physical Function (Oswestry Low Back Pain Disability Index Questionnaire)
3. Quality of Life (WHOQOL-BREF)
General information
Reason for update
Acronym
EDCTWWTMPFSALBPP
IRCT registration information
IRCT registration number:IRCT20250415065342N1
Registration date:2025-04-25, 1404/02/05
Registration timing:registered_while_recruiting
Last update:2025-04-25, 1404/02/05
Update count:0
Registration date
2025-04-25, 1404/02/05
Registrant information
Name
Mirza Usman Baig
Name of organization / entity
Lahore Physiotherapy and Rehabilitation Center
Country
Pakistan
Phone
+92 309 7759756
Email address
usmanbaig513@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-16, 1404/01/27
Expected recruitment end date
2025-06-11, 1404/03/21
Actual recruitment start date
2025-04-16, 1404/01/27
Actual recruitment end date
2025-06-11, 1404/03/21
Trial completion date
2025-06-12, 1404/03/22
Scientific title
Effectiveness Of Dry Cupping Therapy With And Without Thoracic Mobilization On Pain And Functional Status Among Low Back Pain Patients
Public title
Effectiveness Of Dry Cupping Therapy With And Without Thoracic Mobilization On Pain And Functional Status Among Low Back Pain Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
18–59 years of age (40)
Both male and female
If the participant is having pain in the spine for the duration of more than 3 months but not radiating to the leg (28)
Any participant who has complain of pain on a scale of 3 to 8 (moderate to severe) according to the NPRS (28)
Exclusion criteria:
If any participants has planned any flights for the next two months
Sacroiliac joint dysfunctioning
Any individual with disorders of spine or spinal cord (e.g. fractures, infection or tumors)
Any participant who can’t receive cupping therapy (e.g. open wound, skin infections)
Any individual who are at risk of falls or having visual or auditory discrepancies
Any individual with psychological or neurological disorders
If any individual is receiving physical therapy interventions
Already treated with cupping therapy
Age
From 18 years old to 59 years old
Gender
Both
Phase
1-2
Groups that have been masked
Investigator
Sample size
Target sample size:
52
More than 1 sample in each individual
Number of samples in each individual:
26
DRY CUPPING THERAPY WITH AND WITHOUT THORACIC MOBILIZATION
Actual sample size reached:
52
More than 1 sample in each individual
Actual sample size in each individual:
26
DRY CUPPING THERAPY WITH AND WITHOUT THORACIC MOBILIZATION
Randomization (investigator's opinion)
Randomized
Randomization description
Purposive sampling, also known as judgmental or selective sampling, is a non-probability sampling technique where researchers intentionally select participants based on their specific characteristics, knowledge, or experiences that are relevant to the research question.
Blinding (investigator's opinion)
Single blinded
Blinding description
The investigator is blinded. Everyone knows the treatment except the investigator.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The University of Lahore
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore
City
Lahore
Postal code
54000
Approval date
2024-10-10, 1403/07/19
Ethics committee reference number
UIPT/201/630//2024
Health conditions studied
1
Description of health condition studied
Health condition studies encompass research investigating various aspects of diseases and health conditions, including their causes, prevention, diagnosis, and treatment. These studies can be broadly categorized into clinical trials, observational studies, and epidemiological studies
ICD-10 code
m54.50
ICD-10 code description
M54.50
Primary outcomes
1
Description
1. Pain
Timepoint
8 weeks
Method of measurement
Numeric Pain Rating Scale
2
Description
• Physical Function
Timepoint
8 weeks
Method of measurement
Oswestry Low Back Pain Disability Index Questionnaire
3
Description
Quality of Life
Timepoint
8 Weeks
Method of measurement
WHOQOL-BREF
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Other
2
Description
Intervention group:
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Lahore Physiotherapy and Rehabilitation Center
Full name of responsible person
Dr. aqsa Khalid
Street address
Plaza # 100-a, Chambeli Commercial, Sector C, Bahria Town Lahore
City
Lahore
Postal code
53720
Phone
+92 309 7759756
Email
lprcenter01@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lahore Physiotherapy and Rehabilitation Center
Full name of responsible person
Mirza Usman Baig
Street address
Plaza # 100-a, Chambeli Commercial, Sector C, Bahria Town Lahore
City
Lahore
Postal code
53720
Phone
+92 309 7759756
Email
lprcenter01@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
academic funds
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Lahore Physiotherapy and Rehabilitation Center
Full name of responsible person
Dr. aqsa Khalid
Position
Clinical Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Plaza # 100-a, Chambeli Commercial, Sector C, Bahria Town Lahore
City
Lahore
Province
Punjab
Postal code
53720
Phone
+92 309 7759756
Email
lprcenter01@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lahore Physiotherapy and Rehabilitation Center
Full name of responsible person
Mirza Usman Baig
Position
CEO
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Plaza # 100-a, Chambeli Commercial, Sector C, Bahria Town Lahore
City
Lahore
Province
Punjab
Postal code
53720
Phone
+92 309 7759756
Email
lprcenter01@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Lahore Physiotherapy and Rehabilitation Center
Full name of responsible person
Mirza Usman Baig
Position
HOD
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Plaza # 100-a, Chambeli Commercial, Sector C, Bahria Town Lahore
City
Lahore
Province
Punjab
Postal code
53720
Phone
+92 309 7759756
Email
lprcenter01@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
EFFECTIVENESS OF DRY CUPPING THERAPY WITH AND WITHOUT THORACIC MOBILIZATION ON PAIN AND FUNCTIONAL STATUS AMONG LOW BACK PAIN PATIENTS
When the data will become available and for how long
it will be available in nine months for 2 years
To whom data/document is available
for everyone
Under which criteria data/document could be used
For RCTs
From where data/document is obtainable
On websites and google search engines
What processes are involved for a request to access data/document