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

NCT04589858 | Completed

• 1 other identifier: RRC-2019-20
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Specified manual therapy; Strengthening exercise; Stretching exercise; Knee OA; NPRS; WOMAC

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

  Assessed by Numeric Pain Rating Scale (NPRS)

  4-weeks

• Functional disability

  Assessed by WOMAC index

  4-weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Other: Supervised exercise protocol

Group B

EXPERIMENTAL

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

Other: Supervised exercise protocol; Other: Specified Manual Therapies

Interventions

Supervised exercise protocol OTHER

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.

Group A; Group B

Specified Manual Therapies OTHER

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.

Group B

Eligibility Criteria

• Age: 47 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

Rehabilitation Research Chair

Riyadh, 11433, Saudi Arabia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• AMIR IQBAL, MPT-Ortho

  Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm parallel groups randomized clinical trial

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: October 19, 2020
• Study Start: September 24, 2019
• Primary Completion: November 27, 2019
• Study Completion: March 5, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)