NCT06913439

Brief Summary

Knee traumas termed as any injury or damage to the knee's joint which is caused by different factors like sports injury, accidents and by fall .Knee stiffness is a common complication of femoral and tibia fracture and injuries to the extensor mechanism of the knee.

Trial Health

55
Monitor

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

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

March 20, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 29, 2025

Last Update Submit

March 29, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • VISUAL ANALOG SCALE (VAS)

    The Visual Analogue Scale (VAS) uses a 10 cm line with anchors like "no pain" and "worst pain imaginable", and the score is determined by measuring the distance (in mm or cm) from the "no pain" end to the patient's mark, ranging from 0 to 100

    12 Months

  • OSTEOARTHRITS INDEX (WOMAC)

    The Oswestry Disability Index (ODI) is a questionnaire used to assess functional disability in individuals with low back pain, with scores ranging from 0% (no disability) to 100% (maximum disability), and interpreted as follows: 0-20% minimal disability, 21-40% moderate, 41-60% severe, 61-80% crippling, and 81-100% bed-bound or exaggerated symptoms

    12 Months

Study Arms (2)

Exercise Group

ACTIVE COMPARATOR
Diagnostic Test: Exercise Group

Parafin Wax Bath

EXPERIMENTAL
Combination Product: Parafin Wax Bath

Interventions

Exercise GroupDIAGNOSTIC_TEST

technique was implemented with three sets of ten repetitions on each treatment occasion for a period of 3 days/ week for 8 weeks. In this group, the adjustable couch was used to treat the patients effectively. During MWM, position of the patients was prone lying and high sitting position with swinging bilateral leg out of the couch at available various range of motion of affected knee joint. In prone lying position, the therapist was stand just behind the patient towards the affected knee joint. The mulligan belt placed at proximal tibia ends which already wrapped with the lower back of the therapist. In high or couch sitting position, the therapist was sitting on rest chair. The method using of mulligan belt was same as in prone lying position. After stabilization, the mobilization with movement (MWM) started in order with the therapist mobilized the knee joint followed by active movement of knee joint performed by the patients

Exercise Group
Parafin Wax BathCOMBINATION_PRODUCT

Group B will receive Paraffin Wax Bath Therapy in combination with standard care exercises. In this treatment, the affected knee joint will be immersed in warm paraffin wax to deliver thermotherapy, which helps reduce joint stiffness, improve circulation, and enhance joint mobility. Each paraffin wax session will last 15-20 minutes. Following the thermotherapy, participants will perform standard care exercises targeting knee mobility, flexibility, and strength. These sessions will also occur 3 times per week over a period of 8 weeks.

Parafin Wax Bath

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40 years.
  • Both Male and female
  • Fracture of the unilateral knee joint and around the knee managed with conservative treatment only.
  • Subjects with post-traumatic stiffness of knee joint having a minimum of 70º knee flexion.
  • Able to walk independently or with minimal assistance.
  • Administer patient in study after 12 weeks of knee injury.

You may not qualify if:

  • deformity of hip and knee.
  • Implant at fracture and around fracture site.
  • Subject having polyarthritis, bleeding disorders, tumors, local infection, peripheral vascular disease, leg-length discrepancy of more than one-half inch.
  • History of knee replacement or other knee surgeries within the last six months.
  • Presence of neurological conditions (e.g., stroke, multiple sclerosis) affecting gait or knee mobility.
  • Known allergy or intolerance to paraffin wax therapy or other study interventions."

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shoukat ismail medical complex

Lahore, Punjab Province, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 6, 2025

Study Start

March 20, 2025

Primary Completion

June 20, 2025

Study Completion

February 20, 2026

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations