search
Back to results

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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mckenzie Extension Protocol
Cupping
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Foundation University Islamabad

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

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: Lying Prone Lying prone in extension Sustained extension Posture correction Dynamic: Extension in lying Extension in lying with clinician overpressure Extension mobilization Extension in standing

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

Outcomes

Primary Outcome Measures

Visual Analogue Scale for Pain
Health Related Quality of life

Secondary Outcome Measures

Full Information

First Posted
August 11, 2021
Last Updated
August 11, 2021
Sponsor
Foundation University Islamabad
search

1. Study Identification

Unique Protocol Identification Number
NCT05007119
Brief Title
"Cupping Therapy Combined With Conventional Physical Therapy Improves Pain and Health Related Quality of Life Among Female Patients of Low Back Pain''
Official Title
"Cupping Therapy Combined With Conventional PT Improves Pain and Health Related Quality of Life Among Female Patients of Low Back Pain''
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 10, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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: Lying Prone Lying prone in extension Sustained extension Posture correction Dynamic: Extension in lying Extension in lying with clinician overpressure Extension mobilization Extension in standing
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Mckenzie Extension Protocol
Intervention Description
Moist Heat Pack for 10 mins McKenzie Extension Protocol Sequence Static: Lying Prone Lying prone in extension Sustained extension Posture correction Dynamic: Extension in lying Extension in lying with clinician overpressure Extension mobilization Extension in standing
Intervention Type
Procedure
Intervention Name(s)
Cupping
Intervention Description
Cupping with blood letting
Primary Outcome Measure Information:
Title
Visual Analogue Scale for Pain
Time Frame
8 weeks
Title
Health Related Quality of life
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female population of age between 30 to 50 years. Female patients with diagnosed low back pain. Exclusion criteria: Female population with cardiological, neurological, circulatory and orthopedic problems opens wounds or bone fractures.
Facility Information:
Facility Name
Foundation University Islamabad
City
Islamabad
State/Province
Federal
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs