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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06233955
Other study ID # Maitland Mobilization and LLLT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date March 1, 2023

Study information

Verified date January 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Osteoarthritis is a common cause of chronic pain and disability in elderly people. Objective: To evaluate the efficacy of low-level laser therapy (LLLT) in combination with Maitland mobilization and conventional physical therapy in patients with chronic knee osteoarthritis. Design: Pre-test post-test randomized control trial.


Description:

Knee OA is associated with pain and disability, high treatment costs, decreased productivity, and absence from work and thus has a substantial and growing burden on society Objective: To evaluate the efficacy of low-level laser therapy (LLLT) in combination with Maitland mobilization and conventional physical therapy in patients with chronic knee osteoarthritis. Participants: Seventy five subjects of both genders with age range from 50 to 65 years, with proven bilateral knee OA diagnosed and referred by orthopaedist were recruited for the study and randomly assigned into three groups.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date March 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 65 Years
Eligibility Inclusion Criteria: Subjects with proven bilateral Knee OA with age range 50- 65 years according to the American College of Rheumatology criteria. 2- Only patients with X-ray stages II and III osteoarthritis selected according to Kellgren & Lawrence classification system. 3- BMI equal to or less than 30 . 4- Patients with Knee pain lasted at least 6 months with intensity at least 3 on VAS scale in activities such as going up-and downstairs, sitting and squatting. 5- Patients with normal mental state. 6- Patients who are not participating in physical therapy in the recent 3 months. . Exclusion Criteria: 1. Patient with history of gout, infection, tumour, autoimmune diseases, trauma or other causes of knee pain or knee deformities. 2. Patient with neurologic dysfunction, or with history of chronic disease that may affect the study. 3. Patient with history of knee intra-articular injection in the past 6 months.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Low Level laser therapy
is a non-invasive light source treatment that generates a single wavelength of light. It emits no heat, sound, or vibration. It is also called photobiology or bio-stimulation
Other:
Maitland mobilization technique
is a process of examination; assessment and treatment of musculoskeletal disorders by manipulative physiotherapy where a chain of oscillatory joint mobilization grades based on the pathological limit of tissue are used

Locations

Country Name City State
Egypt Faculty of physical therapy Cairo university Cairo Dokki

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analogue scale Is a bidirectional 10 cm straight line with two labels, that is, "no pain" and "worst possible pain", located at either end of the line. Patients were instructed to draw a vertical mark on the line indicating their pain level where zero mean no pain and 10 means worst imaginable pain Four weeks
Primary Pressure Algometer is a handheld pressure algometer that responds linearly to force application between 0 and 5 Kg and it has a 1-cm2 round rubber tip. Four weeks
Primary Knee digital goniometry Baseline digital absolute + axis TM goniometer was used which consisted of one movable arm and one fixed arm and fulcrum Four weeks
Secondary Knee injury and osteoarthritis outcome score short form consists of a seven items measure of physical function descended from the items of the function, daily living and function, sports and recreational activity subscales of the KOOS Item responses are coded from 0 to 4, none to extreme respectively. The questionnaire is scored by summing the raw response (range 0-28) and then using the nomogram so the raw score is converted to a true interval score (0-100) where zero means no difficulty and 100 means extreme difficulty Four weeks
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