- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06913439
Fin Wax Bath Therapy in Patients With Post-traumatic Stiffness of Knee Joint: A Randomized Controlled Trial
March 29, 2025 updated by: Muhammad Naveed Babur, Superior University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
There are many types of trauma of knee joint such as anterior cruciate ligament (ACL) tear, posterior cruciate ligament (PCL) tears, medial collateral ligament (MCL) tear, lateral collateral ligament (LCL) tear and meniscal tears etc. Post-traumatic knee stiffness is a commonest problem after knee injuries or surgical procedure.
It affects significantly patient's quality of life and making daily living activities challenging.
Paraffin wax bath therapy involves soaking targeted area in a warm paraffin wax bath pour hot liquid form wax on target area.The heat from the wax increase blood circulation in the affected areas.
Mobilization with Movement (MWM) is a type manual therapy technique includes combination of joint mobilization with movement to improve joint mobility, decrease pain and improve functional ability.
MWM play a role of application of joint mobilization and active movement simultaneously.
The researcher employs a randomized controlled trial methodology.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan
- Shoukat ismail medical complex
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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."
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Exercise Group
|
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
|
|
Experimental: Parafin Wax Bath
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VISUAL ANALOG SCALE (VAS)
Time Frame: 12 Months
|
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)
Time Frame: 12 Months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2025
Primary Completion (Estimated)
June 20, 2025
Study Completion (Estimated)
February 20, 2026
Study Registration Dates
First Submitted
March 29, 2025
First Submitted That Met QC Criteria
March 29, 2025
First Posted (Actual)
April 6, 2025
Study Record Updates
Last Update Posted (Actual)
April 6, 2025
Last Update Submitted That Met QC Criteria
March 29, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- MSRSW/Batch-Fall23/799
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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