Clinical trial NCT04589858: Effect of Manual Therapies With Supervised Exercise Protocol on Pain and Functional Disability in Patients With Knee OA
Official title: Efficacy of Specified Manual Therapies in Combination With a Supervised Exercise Protocol on Managing Pain Intensity and Functional Disability in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Specified manual therapy
Strengthening exercise
Stretching exercise
Knee OA
NPRS
WOMAC
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 32
Sex: ALL
Minimum age (years): 47
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel groups randomized clinical trial
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA) is referred to a group of conditions that involve mostly the larger weight-bearing joints such as the hip, knee, and ankle. It is the result of an intricate, multifaceted, progressive softening and break-down of articular cartilage along with capsular fibrosis and re-growth of new cartilages and bones called osteophytes at the margin of the articular surfaces to increase the surface area of them.

The current study aimed to find out the efficacy of specified manual therapies in combination with a supervised exercise protocol on managing pain intensity and functional disability in patients with knee osteoarthritis.

Detailed description: Out of 70-millions older adults in the America, the majority of females have been suffering from osteoarthritis (OA) that progressively lead to chronic pain, joint stiffness, reduced mobility, muscle atrophy, poor balance, and ultimately, physical disability. Other physiological changes such as reduction in quadriceps' muscle strength and range of motion (ROM) in sagittal plane, and shortening of soft tissues around the joints collectively yield the distinctive clinical features such as articular pain; worsening on weight -bearing activities, resting/morning joint stiffness, progressive decline in physical activities and increasing to deformities/disabilities.Researchers observed the effectiveness of a structured exercise programs including an aerobic exercise program, a resistance exercise program, and a health education program in improving functional outcomes (self-reported disability) and decreasing the knee pain among older adults with knee OA at short-term and long term.the manual therapy along with supervised exercise protocol revealed a significant reduction in joint stiffness and knee pain and improvement in functional status of the patients with knee OA for short-term and long-term (1-year follow-up) than the placebo therapy (sub-therapeutic dose of ultrasound).

The study based on a randomized, pretest-posttest experimental group design, included a total of 32-participants with knee osteoarthritis randomly divided into groups A and B. Group A received a supervised exercise protocol, however group B received specified manual therapies in a combination of a supervised exercise protocol. Pain and functional disability measured with NPRS and WOMAC index respectively. Data collected on day-1st pre-intervention (baseline), day-14th posttest, and day-28th follow-up and analyzed using t-test and one-way ANOVA by keeping the level of significance at p\<0.05.

Eligibility criteria: Inclusion Criteria:

* aged between 47 to 60 years;
* mild to moderate pain in one/both knees for 3-months;
* the pain intensity score between 2 to 6 on NPRS;
* morning stiffness \<30-minutes;
* Self-reported crepitus on knee motion;
* grade 1 to 3 on Kellgren-Lawrence radiographic grading scale for Knee OA

Exclusion Criteria:

* diagnosed case of post-traumatic knee stiffness;
* history of bone infection and malignancy (osteomyelitis and tumour); neurological disorder (sciatica);
* history of joint replacement/meniscal surgery/mechanical knee pain/infection to the knee joint; suffering from severe cardiopulmonary disease (chronic obstructive pulmonary disease);
* Patient showed non-cooperation

Primary outcomes:
measure: Pain Intensity
timeFrame: 4-weeks
measure: Functional disability
timeFrame: 4-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Rehabilitation Research Chair
Study officials:
affiliation: Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia
name: AMIR IQBAL, MPT-Ortho
role: PRINCIPAL_INVESTIGATOR
References: