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Effect of Manual Therapies With Supervised Exercise Protocol on Pain and Functional Disability in Patients With Knee OA

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Supervised exercise protocol
Specified Manual Therapies
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Specified manual therapy, Strengthening exercise, Stretching exercise, Knee OA, NPRS, WOMAC

Eligibility Criteria

47 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation Research Chair

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Arm Description

Received a supervised exercise protocol including both strengthening and stretching exercises for specific muscle groups.

Received manual therapies including both myofascial mobilization and manipulation technique in addition to a supervised exercise protocol.

Outcomes

Primary Outcome Measures

Pain Intensity
Assessed by Numeric Pain Rating Scale (NPRS)
Functional disability
Assessed by WOMAC index

Secondary Outcome Measures

Full Information

First Posted
October 11, 2020
Last Updated
October 18, 2020
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT04589858
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 24, 2019 (Actual)
Primary Completion Date
November 27, 2019 (Actual)
Study Completion Date
March 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Specified manual therapy, Strengthening exercise, Stretching exercise, Knee OA, NPRS, WOMAC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm parallel groups randomized clinical trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Received a supervised exercise protocol including both strengthening and stretching exercises for specific muscle groups.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Received manual therapies including both myofascial mobilization and manipulation technique in addition to a supervised exercise protocol.
Intervention Type
Other
Intervention Name(s)
Supervised exercise protocol
Intervention Description
Strengthening exercises:It included a sets/group of exercises such as a static quad set in knee extension, standing terminal knee extension, seated leg-press, partial squats weight-lessened with arm support as needed, and step-ups Stretching Exercises:A slow, sustained stretching was performed in different positions for different group of muscles with holding time 30-seconds, a gap of 1-minute between two repetitions, and repeated 3-times per session on alternate day for 2-weeks. The stretching performed for the calf muscle, hamstring muscle, and quadriceps femoris muscle in standing, supine, and prone positions respectively.
Intervention Type
Other
Intervention Name(s)
Specified Manual Therapies
Intervention Description
Myofascial Mobilization: Patellar glide performed in all available ROM and direction such as superior-inferior and lateral-medial translation/glides of patella over patellar fossa. Myofascial manipulation technique: Manipulation of knee joint. An impulse type thrust was delivered, directed in the caudal direction to mobilize the joint in a near-full extension position.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Assessed by Numeric Pain Rating Scale (NPRS)
Time Frame
4-weeks
Title
Functional disability
Description
Assessed by WOMAC index
Time Frame
4-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
47 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AMIR IQBAL, MPT-Ortho
Organizational Affiliation
Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Research Chair
City
Riyadh
ZIP/Postal Code
11433
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Manual Therapies With Supervised Exercise Protocol on Pain and Functional Disability in Patients With Knee OA

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