"Cupping Therapy Combined With Conventional Physical Therapy Improves Pain and Health Related Quality of Life Among Female Patients of Low Back Pain''

August 11, 2021 updated by: Foundation University Islamabad

"Cupping Therapy Combined With Conventional PT Improves Pain and Health Related Quality of Life Among Female Patients of Low Back Pain''

A randomized control trial will be done on diagnosed Low Back Pain patients in Fauji Foundation Hospital Rawalpindi. There is a growing interest and demand in the field of Complementary And Alternative Medicine(CAM), nowadays .The purpose of the study is to determine the effects of cupping therapy combined with conventional physical therapy to exercise to lower the pain and improve the health related quality of life of the patient using the modified SF - 36 scale. The conventional physical therapy includes hot pack placed on the low back region for ten minutes, interferential current therapy was used which has four round electrodes measuring 2.75 inches placed on the desired area(low back) waveform used was IFC- 4p , having a carrier frequency of 4000 Hz and a frequency of 80/150 Hz, vector scan was off , the intensity was increased manually according to the capacity of the patient and the treatment time was 15 minutes, strenghtening exercises such as william flexion were done once in the rehabilition center and patient was given a home plan to follow twice daily with 15 repitions each.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Experimental Group (A) = This group will receive cupping therapy every month combined with conventional physical therapy whhich includes hot pack , interferential therapy and streghtening exercises for back and their outcomes wi;; be measured at baseline and at the end of 6th month treatment..

Control group (B) =this group will not receive cuppping therapy , only conventional Physical therapy will be given and their outcomes will be observed at the baseline and then after treatment of 06 months.

Data analysis techniques:

The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study within the community using the VAS scale.

A printed questionnaire will be provided to the parents after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables.

Significance of the study:

This study will make people become aware of their current physical fitness level, so the lifestyle behaviors can be modified if needed, in order to improve their quality of life This study will help create awareness among the people, it is not only economically accessible but also have very little chances of side effects This study will open new doors for researchers to do long term studies on different types of pain with different exercise types.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 46000
        • Foundation University Islamabad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female population of age between 30 to 50 years.
  2. Female patients with diagnosed low back pain.

Exclusion criteria:

Female population with cardiological, neurological, circulatory and orthopedic problems opens wounds or bone fractures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group

It includes participants receiving conventional physical therapy for low back pain female patients for a period of 6 months.

McKenzie extension exercise Protocol Moist Heat Pack for 10 mins McKenzie Extension Protocol Sequence

Static:

  1. Lying Prone
  2. Lying prone in extension
  3. Sustained extension

  4. Posture correction

    Dynamic:

  5. Extension in lying
  6. Extension in lying with clinician overpressure
  7. Extension mobilization
  8. Extension in standing
Procedure: Mckenzie Extension Protocol

Moist Heat Pack for 10 mins McKenzie Extension Protocol Sequence

Static:

  1. Lying Prone
  2. Lying prone in extension
  3. Sustained extension

  4. Posture correction

    Dynamic:

  5. Extension in lying
  6. Extension in lying with clinician overpressure
  7. Extension mobilization
  8. Extension in standing
Experimental: Experimental Group

Group (A) Involves participants receiving cupping therapy along with conventional physicla therapy for a period of 6 months .

Moist Heat Pack for 10 mins McKenzie Extension Exercise Protocol
Procedure: Mckenzie Extension Protocol

Moist Heat Pack for 10 mins McKenzie Extension Protocol Sequence

Static:

  1. Lying Prone
  2. Lying prone in extension
  3. Sustained extension

  4. Posture correction

    Dynamic:

  5. Extension in lying
  6. Extension in lying with clinician overpressure
  7. Extension mobilization
  8. Extension in standing
Procedure: Cupping
Cupping with blood letting

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Visual Analogue Scale for Pain
Time Frame: 8 weeks
8 weeks
Health Related Quality of life
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Foundation University Islamabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FUI/CTR/2020/9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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