NCT05812898

Brief Summary

the aim of the study is to investigate the effect of deep front line myofascial release to selected exercises in patients with knee osteoarthritis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2023

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

January 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

April 1, 2023

Last Update Submit

February 5, 2024

Conditions

Keywords

myofascial releaseKnee osteoarthritisDeep front line

Outcome Measures

Primary Outcomes (4)

  • pain intensity

    The scale that will be used the visual analogue scale;each subject will instructed to record pain intensity on line of 100mm. Starting from no pain on the leftto the most sever pain imaginable on the right Patient will choose the point which describe his pain.the more the score toward the end the more severe pain

    up to four weeks

  • function

    The Arabic version of reduced Western Ontario and McMasters University Osteoarthritis Index (ArWOMAC) index will be used to measure functional disability.is a self-administered questionnaire consisting of 24 items divided into 3 subscales: * Pain (5 items): During walking, using stairs, in bed, sitting or lying, and standing upright * Stiffness (2 items): After first waking and later in the day Physical Function (17 items).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.Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations

    up to four weeks

  • rang of motion

    using digital inclinometer

    up to four weeks

  • joint position sense

    using digital inclinometer for target angle 30 degree knee flexion

    up to four weeks

Study Arms (2)

control group

SHAM COMPARATOR

The control group received selective exercises therapy in the form of strengthening and stretching exercises for selective muscles of hip and knee

Other: exercises

study group

EXPERIMENTAL

The study group received selective exercises therapy in the form of strengthening and stretching exercises for selective muscles of hip and knee, plus myofascial release technique of the deep front line.

Other: exercisesOther: myofascial release

Interventions

strengthening of the gluteus maximus and medius, calf muscles stretching for calf and hamstring muscles

control groupstudy group

myofascial release using instrument assisted soft tissue mobilization

study group

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mild to moderate unilateral or bilateral medial tibiofemoral OA grade II-III (K/L).
  • The age of the participants will range from 45 to 60 years old .
  • BMI ranged from 20-30 kg/m2

You may not qualify if:

  • Severe knee OA (grade IV according to K/L classification).
  • Congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee.
  • Patients receiving oral or injected corticosteroids for the last 3 months .
  • History of knee surgery/fracture.
  • Patients with ACL and meniscus injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hoda Mohamed Ahmed

Giza, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

ExerciseMyofascial Release Therapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • hoda m Ahmed, bachelor

    phyical therapist at Cairo university hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: exercise plus myofascial release of the adductor and tipialis posterior muscles.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 1, 2023

First Posted

April 14, 2023

Study Start

January 1, 2023

Primary Completion

April 1, 2023

Study Completion

May 15, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations