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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05007119
Other study ID # FUI/CTR/2020/9
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 10, 2020
Est. completion date December 1, 2020

Study information

Verified date July 2020
Source Foundation University Islamabad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Mckenzie Extension 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
Cupping
Cupping with blood letting

Locations

Country Name City State
Pakistan Foundation University Islamabad Islamabad Federal

Sponsors (1)

Lead Sponsor Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale for Pain 8 weeks
Primary Health Related Quality of life 8 weeks
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