NCT05110326

Brief Summary

The study will be a randomized control trial and will be conducted in Pakistan Railway Hospital Rawalpindi. A sample of 60 participants will be taken. Patients will be divided into two groups (A\&B) of 30 participants in each group by sealed envelope method. Hot pack will be applied to both groups for 15 minutes at the start of intervention. ERGON Technique(IASTM) will be applied to group A along with strengthening exercise. Proprioceptive Neuromuscular Facilitation (PNF) stretching will be given to group B along with strengthening exercise. A 35 minute session will be given to the patients and 3 sessions will be given once a week. Intervention will be given for 6 weeks. The outcome measure will be Visual analog Scale (VAS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), and Active Knee Extension Test (AKE) will be measured at baseline and at the end of 6th week. Data will be analyzed by SPSS 22.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 5, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2022

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

October 26, 2021

Last Update Submit

March 15, 2023

Conditions

Keywords

knee osteoarthritisErgon TechniqueProprioceptive Neuromuscular Facilitation stretchingActive Knee Extension TestWestern Ontario and McMaster Universities Arthritis IndexVisual Analogue Scale

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale (VAS)

    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. It is used to find out the intensity of pain.

    6 Weeks

  • Western Ontario and McMaster Universities Arthritis Index(WOMAC)

    The Western Ontario and McMaster Universities Arthritis Index(WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales.

    6 Weeks

  • Active Knee Extension Test

    The Active Knee Extension Test is used to assess hamstring muscle length and the range of active knee extension in the position of hip flexion.

    6 Weeks

Study Arms (2)

ERGON Technique Group

EXPERIMENTAL

Patients in this group will receive ERGON Technique along with conventional therapy

Other: ERGON Technique

Proprioceptive Neuromuscular Facilitation(PNF) stretching Group

EXPERIMENTAL

Patients in this group will receive Proprioceptive Neuromuscular Facilitation (PNF) stretching along with conventional therapy

Other: Proprioceptive Neuromuscular Facilitation (PNF) stretching

Interventions

* Hot pack for 15 minutes. * Patient position: Prone with knee flexion approximately 45◦. * Position of therapist: Standing at the affected side of patient. * Technique:Massage cream will be applied on the hamstring and overactive or short muscle fibres that are restricted.The instrument will be applied parallel to the muscle fibers, both in a distal to proximal and them proximal to distal direction as needed.Then gentle massage stroking from the origin to the insertion will be performed using the instrument. Instrument Assisted Soft Tissue Mobilization(IASTM) will be applied for 5 minutes. * Strengthening exercises for quadriceps and hamstring will then be performed. * Isometrics exercises of Quadriceps: By placing a towel roll below the knee and press and hold for 20 seconds, 5 sets. * Isometrics exercises Hamstrings: By placing a towel roll below the knee and press and hold for 20 seconds, 5 sets. * Wall sits: For 10 seconds, 5 sets.

ERGON Technique Group

* The patient will be laid down prone and moist heat will be given for 15 minutes prior to stretching the hamstrings. * Then patient will be lying supine with hip in 90⁰ of flexion. Patient's knee will be extended until a very mild stretching sensation is felt in hamstring muscles. * Then patient will be asked to flex the knee against the resistance applied by hand of therapist. * The patient will be asked to use a force of around 50% of maximal strength and an isometric form of contraction will be gained in the hamstring muscles. The patient will hold the contraction for 8 seconds and then the therapist command to relax the hamstring muscle. * Immediately after the muscle relaxation the therapist further stretches the hamstring muscles up to a point where the subject reported a mild to moderate stretching sensation without any pain and will be held for 30 seconds. * The procedure will be repeated 3 times in every session. Strengthening Exercises: * Same as ERGON Group

Proprioceptive Neuromuscular Facilitation(PNF) stretching Group

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unilateral/bilateral osteoarthritis
  • Participants with unilateral/bilateral hamstring tightness
  • from Active Knee Extension test
  • Grade 1 and 2 in Kellgren and Lawrence criteria for knee osteoarthritis

You may not qualify if:

  • Participant failing to fall in the category below will be excluded from the study:
  • Any lower extremity injury in past 3 months
  • Any fracture or surgery done for pelvis, hip or knee.
  • Any neurological symptoms.
  • Any recent knee reconstructive surgery
  • Burns of lower extremities
  • Other musculoskeletal disorders associated with knee joint, Iliotibial band, adductor muscle and Sartorius muscle tightness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RHS Rehabilitation Centre

Islamabad, 44000, Pakistan

Location

Related Publications (1)

  • Anjum N, Sheikh RK, Omer A, Anwar K, Khan MMH, Aftab A, Awan WA. Comparison of instrument-assisted soft tissue mobilization and proprioceptive neuromuscular stretching on hamstring flexibility in patients with knee osteoarthritis. PeerJ. 2023 Dec 1;11:e16506. doi: 10.7717/peerj.16506. eCollection 2023.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Waqar Ahmed Awan, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 5, 2021

Study Start

January 10, 2022

Primary Completion

May 30, 2022

Study Completion

June 25, 2022

Last Updated

March 17, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations