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CompletedNCT04589858Updated Oct 22, 2020

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

An interventional study of Supervised exercise protocol and Specified Manual Therapies in Knee Osteoarthritis, sponsored by King Saud University. Completed at 1 site in Saudi Arabia. Open to participants aged 47 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by King Saud University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Sep 2019, registered Oct 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
47 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Specified manual therapy
  • Strengthening exercise
  • Stretching exercise
  • Knee OA
  • NPRS
  • WOMAC
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 32 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

King Saud University is the lead sponsor of 164 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
47 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    Group A

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

    Other: Supervised exercise protocol

  • Experimental
    Group B

    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

  • OtherSupervised exercise protocol

    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.

  • OtherSpecified Manual Therapies

    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.

06

What researchers measure

Primary outcomes

  1. Pain Intensity

    Assessed by Numeric Pain Rating Scale (NPRS)

    Time frame: 4-weeks

  2. Functional disability

    Assessed by WOMAC index

    Time frame: 4-weeks

07

Study locations

1 site
  • Rehabilitation Research Chair
    Riyadh, 11433, Saudi Arabia
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04589858
Lead sponsor
King Saud University
Responsible party
AMIR IQBAL (Principal Investigator, King Saud University) — Principal investigator
First posted
Oct 19, 2020
Start date
Sep 24, 2019
Primary completion
Nov 27, 2019
Completion
Mar 5, 2020
Last update
Oct 22, 2020

Study contacts

AMIR IQBAL, MPT-Ortho
principal investigator · Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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