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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05173948
Other study ID # UT-79-11-2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2019
Est. completion date August 30, 2020

Study information

Verified date December 2021
Source University of Tabuk
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to determine the effectiveness of Kinesio taping (KT) with Conventional Physical therapy (CPT) - Transcutaneous Electrical Nerve Stimulation (TENS) and Supervised Exercise therapy and CPT in the management of CLBP.


Description:

Chronic low back pain (CLBP) is one of the most common causes of chronic disability which leads to major social and economic consequences. The role and effectiveness of the Kinesio taping (KT) and Conventional Physical therapy (CPT) are evident from the existing literature but no comparison was found on the combination of other physical therapy techniques such as supervised exercise therapy and Transcutaneous Electrical Nerve Stimulation (TENS) with CLBP in the Kingdom of Saudi Arabia


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Pain caused by mechanical/nonspecific low back pain. - Degeneration of the spine and intervertebral disc. - The visual analog scale of pain 4 and above - Low back pain for at least three months Exclusion Criteria: - Physical therapy treatment is taken in the past 6 months period - Previous spinal surgery with fixation - Structural anomalies - Spinal cord compression - Severe osteoporosis - Acute infections - Severe cardiovascular or metabolic diseases - Pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Kinesio taping
Kinesio taping: The tape is measured from the sacrum to the 12th thoracic vertebra with forwarding flexion of the trunk. The base is affixed to the insertion in the resting position. The muscle is elongated and the base anchored with skin displacement. The tape is then affixed with 10% stretch paravertebrally over the muscle bundles up to T12. The tape is rubbed with the muscle in the elongated state.
Device:
Conventional physical therapy
Transcutaneous electrical nerve stimulation device settings, such as the frequency of 80 Hz, the pulse width of 100 µs, and symmetrical biphasic waveform. Four mediums sized (2 × 2 cm) carbon-impregnated rubber cutaneous electrodes were placed bilaterally in a standard dermatomal pattern over the most painful lumbar region. The current intensity was increased up to the patient's perception of paraesthesia. The supervised exercise therapy management consisted of stretching exercises for the back, iliopsoas, gluteal and hamstring muscles, and strengthening exercises for the abdominal and back muscles. Three sets of stretching exercises, each involving a 30-sec hold and 30-sec of rest repeated three times, were performed in three sessions per week over four weeks. One set of strengthening exercises, consisting of 10 repetitions with a 5-sec hold, was performed in three sessions per week over four weeks.

Locations

Country Name City State
Saudi Arabia University of Tabuk Tabuk North West

Sponsors (1)

Lead Sponsor Collaborator
University of Tabuk

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numerical Pain Rating Scale Pain, for the Average pain intensity over the last week was measured on a numerical pain rating scale, where 0 represented no pain and 10 represented the worst pain possible Six weeks
Primary Modified Oswestry low back pain disability questionnaire Disability were measured using the Modified Oswestry Disability Index (MODI) which is a self-rating questionnaire used to evaluate functional physical disability Six weeks
Primary Lumbar range of motion-Modified Schober test Lumbar flexion range of motion were measured by using modified Schober method Six weeks
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