NCT05767788

Brief Summary

Movement with mobilization (MWM) is an effective manual therapy to improve pain and function of patients with knee osteoarthritis (OA). However, immediate, and prolonged effects after prolonged MWM period was under-investigated. In this double-blinded randomized control trial, 40 patients are needed. The subjects and assessors will be blinded. Subjects in intervention group will receive MWM twice a week and corresponding home exercise for 6 weeks. Participants in control group will only receive sham treatment with light touch. The effects on knee pain in visual analogue scale (VAS); flexion and extension range of motion (ROM) by goniometer; strength by hand-held dynamometer; function by Timed Up and Go Test (TUG) and 30-second Chair Stand Test; and health-related quality of life (HRQoL) by Knee Injury and Osteoarthritis Outcome Score (KOOS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) just after, 1-month and 3-month after treatment will be compared with baseline. Six-month after treatment, KOOS and WOMAC will be conducted.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
Last Updated

March 14, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

January 31, 2023

Last Update Submit

March 2, 2023

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

  • Change of pain in the Visual Analogue Scale (VAS)

    Subjects will indicate the pain level on a 100-millimeter line with endpoints, marked "no pain" and "worst imaginable pain", at the time of assessment.

    The change before the start of treatment and after 6-week treatment

  • Change of pain in the Visual Analogue Scale (VAS)

    Subjects will indicate the pain level on a 100-millimeter line with endpoints, marked "no pain" and "worst imaginable pain", at the time of assessment.

    The change before the start of treatment and 1-month after last treatment session

  • Change of pain in the Visual Analogue Scale (VAS)

    Subjects will indicate the pain level on a 100-millimeter line with endpoints, marked "no pain" and "worst imaginable pain", at the time of assessment.

    The change before the start of treatment and 3-month after last treatment session

Secondary Outcomes (26)

  • Change of time used in the Timed Up and Go Test (TUG)

    The change before the start of treatment and after 6-week treatment

  • Change of time used in the Timed Up and Go Test (TUG)

    The change before the start of treatment and 1-month after last treatment session

  • Change of time used in the Timed Up and Go Test (TUG)

    The change before the start of treatment and 3-month after last treatment session

  • Change of number of repetitions in the 30-second Chair Stand Test (30CST)

    The change before the start of treatment and after 6-week treatment

  • Change of number of repetitions in the 30-second Chair Stand Test (30CST)

    The change before the start of treatment and 1-month after last treatment session

  • +21 more secondary outcomes

Study Arms (2)

Movement with Mobilization (MWM)

EXPERIMENTAL

Active movement with passive mobilization gliding force

Other: Movement with Mobilization (MWM)

Sham Movement with Mobilization (Sham MWM)

SHAM COMPARATOR

Active movement with passive light touch gliding force

Other: Sham Movement with Mobilization (Sham MWM)

Interventions

Movement with Mobilization (MWM)OTHER

Painful active functional knee movement is identified. The most comfortable passive medial, lateral, medial rotatory, lateral rotatory, postero-anterior, and antero-posterior glide, is applied to the knee of the patient. Three sets of 10 repetitions are applied. Corresponding home MWM exercise is taught. The treatment is conducted for 12 sessions over 6 weeks.

Movement with Mobilization (MWM)
Sham Movement with Mobilization (Sham MWM)OTHER

Painful active functional knee movement is identified. The most comfortable passive medial, lateral, medial rotatory, lateral rotatory, postero-anterior, and antero-posterior light-touch glide, is applied to the knee of the patient. Three sets of 10 repetitions are applied. Corresponding home MWM exercise is taught. The treatment is conducted for 12 sessions over 6 weeks.

Sham Movement with Mobilization (Sham MWM)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of knee OA for at least 1-year
  • Pain intensity level ≥ 3 on a 10-cm Visual Analogue Scale (VAS)
  • Both unilateral or bilateral knee pain
  • Having morning stiffness less than 30 minutes
  • Having crepitus on active movement
  • Having bony tenderness
  • Having bony enlargement

You may not qualify if:

  • Having active inflammatory or infectious knee conditions
  • Having bone integrity conditions like osteoporosis
  • Having knee joint instability
  • Having skin integrity conditions like frail skin or lower limb peripheral vascular disease
  • History of hip or knee fracture
  • History of knee surgical history
  • Use of knee corticosteroid or opioid injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Movement

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • KING HIM CHAN, BSc

    Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

  • MING HON LEE, BSc

    Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

  • YIK SING SHUM, BSc

    Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

  • YEUK LAI CHAN, BSc

    Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

  • FADI AL ZOUBI, PhD

    Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

  • MAN HA TSANG, PhD

    Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

    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
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

March 14, 2023

Study Start

December 10, 2022

Primary Completion

May 10, 2023

Study Completion

May 10, 2023

Last Updated

March 14, 2023

Record last verified: 2023-01

Locations

HK(1)