NCT06025929

Brief Summary

This study aimed to determine the effects of different manual mobilization techniques on pain, muscle strength, and functional limitations in individuals with knee osteoarthritis (Knee OA). A double-blinded pretest-posttest experimental study. This research employed a two-arm parallel group randomized comparative design. A total of thirty participants diagnosed with knee osteoarthritis were randomly assigned and equally divided into groups 1 and 2, each containing 15 participants. Both Group 1 and Group 2 underwent Maitland and Mulligan mobilization techniques, alongside a common Interferential therapy (IFT) regimen, over the course of three sessions per week for a duration of four weeks. The assessment of pain and functional disability outcomes was conducted through the application of The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores at the baseline and four weeks following the intervention. To determine the effects of the intervention within and between the groups, the outcome scores were subjected to analysis using both dependent and independent t-tests.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

August 29, 2023

Last Update Submit

September 6, 2023

Conditions

Keywords

Maitland mobilizationMulligan mobilizationKnee painInterferential therapyWOMACFunctional limitation

Outcome Measures

Primary Outcomes (1)

  • Functional limitations

    Functional limitations was assessed using the Western Ontario and McMaster Universities (WOMAC) index. It includes five questions about pain, two about stiffness, and 17 on degree of disability of activities of daily living. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.

    4 weeks

Study Arms (2)

Maitland Group

EXPERIMENTAL

Maitland Group received Maitland's mobilization techninque in addition to an intereferential therapy.

Other: Maitland's mobilization techniqueOther: Interferential Therapy (IFT)

Mulligan Group

ACTIVE COMPARATOR

Mulligan Group received Mulligan's mobilization techninque in addition to an intereferential therapy.

Other: Mulligan's mobilization techniquesOther: Interferential Therapy (IFT)

Interventions

Maitland's mobilization technique was performed on the patients with its all components, such as 1. Distraction 2. Anteroposterior glides 3. Posteroanterior glides 4. Medial glides and 5. Lateral glides.

Maitland Group

Mulligan's mobilization technique was performed on the patients with its all components using a therapeutic belt, such as 1. Medial mobilization with movement (MWM) for Knee flexion 2. Medial mobilization with movement (MWM) for Knee extension 3. Lateral mobilization with movement (MWM) for Knee flexion 4. Lateral mobilization with movement (MWM) for Knee extension.

Mulligan Group

Interferential Therapy was performed on the patients with the following parameters: career frequency 4000Hz; waveform: rectangular; sweep time: 1 second rise and fall and 5 second stay; Treatment duration: 10 minutes; sweep frequency: 10 to 130 Hz. The current intensity was adjusted until the subject reported feeling a strong tingling sensation without causing muscle contraction. A aquatic gel was applied before straping the electopads over treatment area for smooth electrical conduction.

Maitland GroupMulligan Group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sub-acute or chronic osteoarthritis of knee.
  • Age between 45-65 years.
  • Gender Male and female.
  • Subjects willing to participate in the study

You may not qualify if:

  • Presence of R.A, polyarthritis or systemic inflammatory arthropathies.
  • History of total knee arthroplasty or major knee trauma injury.
  • Fracture of lower limb within the past 6 months.
  • Hip or ankle instability, excessive weakness, surgery or major trauma injury.
  • Intra-articular steroid injection in knee joint within 3 months.
  • Cognitive problems.
  • Patient with severe cardiac or pulmonary disorders.
  • Peripheral vascular disease.
  • Tumour/malignancies/infections.
  • Metallic implants in the lower limbs.
  • Any severe deformity around the knee joint.
  • Kellgren and Lawrence (KL) system47: up to grade 0-III.
  • History of neurological and psychological disorders.
  • High risk health status- e.g.- uncontrolled hypertension, diabetes, heart disease, angina type pain, nocturnal dyspnoea, shortness of breathing, tachycardia etc.
  • Contraindications of IFT and mobilization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Sciences, College of applied Medical Science, King Saud University

Riyadh, 11433, Saudi Arabia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • AMIR IQBAL, MPT

    King Saud University

    STUDY CHAIR

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
Prinicipal Investigator

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 6, 2023

Study Start

April 10, 2017

Primary Completion

September 14, 2017

Study Completion

October 30, 2017

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations