NCT05529914

Brief Summary

A randomized control trial will be conducted at the outpatient department of Dow Institute of Physical Medicine and Rehabilitation. A sample size of 80 is calculated using PASS version 11 software. The subjects will be first screened and those who fulfill the inclusion criteria, will be asked to fill the consent form. After selection, the participants will be randomly allocated by the help of computer generated randomization sheet, into two groups i.e. experimental and the control group. The group A will be provided with the myofascial release along with the neuromuscular training whereas the group B will only receive the neuromuscular training. Cold pack will be applied to both the groups. The neuromuscular training consists of warm-up phase, lunges, sideways exercises, wall squats, weight transfer exercises, step up and down and the cool down phase. Total 12 sessions of 35 minutes each will be given to all the participants for about 4 weeks on alternate days. Outcome measures will be analyzed by visual analogue scale (VAS) for pain assessment, goniometry for range of motion and the Knee injury and Osteoarthritis Outcome Score (KOOS) to evaluate the functional assessment of the patients at the baseline and the post intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

September 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

September 27, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

September 3, 2022

Last Update Submit

January 7, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in pain intensity on visual analogue scale after four weeks

    The Visual Analogue Scale is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between pains with similar conditions.. It is 0 to 10 cm scale. Patients rate their pain on that scale. Higher the score in centimeter, severe will be the pain experienced.

    Baseline and 4 weeks

  • Change in range of motion assessed with universal goniometer after four weeks

    The Goniometer is an instrument for the precise measurement of range of movement angles in degree , especially one used to measure the angles before and after range of motion.. Increase in the degree of angle suggests increase in range of movement.

    Baseline and 4 weeks

Secondary Outcomes (1)

  • Change in functional disability assessed with Knee injury and osteoarthritis outcome score after four weeks.

    Baseline and 4 weeks

Study Arms (2)

Myofascial release + Neuromuscular exercises + Cold pack

EXPERIMENTAL
Other: Myofascial releaseOther: Neuromuscular exercisesOther: Cold pack

Neuromuscular exercises + Cold pack

ACTIVE COMPARATOR
Other: Neuromuscular exercisesOther: Cold pack

Interventions

It is a type of physical therapy often used to treat myofascial pain syndrome with pressure.

Myofascial release + Neuromuscular exercises + Cold pack

Exercises commonly utilized in neuromuscular training programs to improve strength, balance , speed and agility. It will comprised of Warm-up, Lunges, Sideways exercises, Wall squats, Weight transfer exercise, Step up \& down, Cool-down

Myofascial release + Neuromuscular exercises + Cold packNeuromuscular exercises + Cold pack

Application of cold pack around the patient's body, and covered with dry towel

Also known as: Cold pack therapy
Myofascial release + Neuromuscular exercises + Cold packNeuromuscular exercises + Cold pack

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and Females both with the age between 40-60 years.
  • Patients with unilateral or bilateral knee osteoarthritis with pes anserine syndrome.
  • Patients with knee pain more than 3.4 cm on visual analogue scale as minimum cut of value.
  • Kellgren and Lawrence grade II and III on radiological findings.
  • Duration of knee osteoarthritis more than 3 months (chronic).

You may not qualify if:

  • Patients with any neurological disorder.
  • Knee deformities such as contractures, genu valgum and genu varum.
  • Septic knee arthritis.
  • History of ligamentous injury or meniscal tear.
  • Cancer or any other malignancy or bone tumor.
  • Any history of previous lower limb arthroplasty or other knee surgery.
  • Comorbid like diabetes mellitus.
  • Inflammatory rheumatic disease (R.A).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dow Institute of Physical Medicine and Rehabilitation

Karachi, Sindh, 74200, Pakistan

Location

Sindh Institute of Physical Medicine and Rehabilitation

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, KneeBursitis

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Farhan I Khan, PhD

    Dow University of Health Sciences

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 3, 2022

First Posted

September 7, 2022

Study Start

September 27, 2022

Primary Completion

March 30, 2023

Study Completion

April 30, 2023

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations