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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05649774
Other study ID # KArshad
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 14, 2022
Est. completion date January 25, 2023

Study information

Verified date January 2023
Source University of Karachi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Lower back pain has been one of the most frequently occurring musculoskeletal disorder among the females. This act as a global burden and is highly prevalent in our society. This pain can result in life long disability, loss of function and mobility among individuals. The female of the society suffers from lower back pain the most because of the under lying causes, prolong standing and stooping as well as because of hormonal changes in their bodies


Description:

After studying the prevalence of the lower back pain among the females of Pakistan, the investogator find the need to assess the type of their pain and find out the best way to ease their pains. The motive was to develop a treatment protocol whose effects last longer and is inexpensive for the management of lower back pain. Moreover, the investigator decided to study that which treatment protocol is better when compared to another and what is the role of sham treatment when given to the patients.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date January 25, 2023
Est. primary completion date January 20, 2023
Accepts healthy volunteers No
Gender Female
Age group 28 Years to 38 Years
Eligibility Inclusion Criteria: - Females who were willing to participate. - Participants with nonspecific lower back pain will only be included and screened through the screening questionnaire. Exclusion Criteria: - Post-menopausal women - Females with any diagnosed co-morbidity. - Back pain progressive to any neurological deficit - Sustained or increased back pain with loss of appetite and unexplained weight loss accompanied with fever, nausea and chills - With any known spinal or lower back pathology - Tumor of the spine - Any underlying diseases of spinal cord (i.e, ankylosing spondylosis, spondolisthesis) - With any steroid therapy for lower back pain in the past three months - Any inflammatory rheumatic disease - Sensitive skin or any skin allergy or dermatological condition - Any rehabilitative services taken for the lower back pain in the past two months - Rejection to manual conatct

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Therapy
Only Myofascial Release will be provided
Taping technique
Only Kinesiotaping will be provided
Therapy with taping
Myofascial release will be provided followed by Kinesiotaping
SHAM
Placebo Treatment will be given

Locations

Country Name City State
Pakistan Al-Tibri Medical college and hospital Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
University of Karachi

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lower Back Pain Numeric Pain Rating Scale Change from baseline to week 3
Primary Disability of lower back Oswestry Disability Index Change from baseline to week 3
Secondary Range of Motion Flexion, Extension and Lateral Bending (L and R) Change from baseline to week 3
Secondary Pain Pressure Threshold Algometer was used to check the pain pressure threshold of Thoraco lumbar fascia, Gluteus Medius, Gluteus Maximus and Tensor Fascia Latae Change from baseline to week 3
Secondary Tissue Hardness Algometer was used to check the tissue hardness of Thoraco lumbar fascia, Gluteus Medius, Gluteus Maximus and Tensor Fascia Latae Change from baseline to week 3
Secondary Quality of Life of patients with Lower back pain 36-Item Short Form Health Survey (SF-36) Change from baseline to week 3
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