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Paraffin Wax Bath With Joint Mobilization Technique in Post-traumatic Stiff Knee

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ClinicalTrials.gov Identifier: NCT06049303
Recruitment Status : Completed
First Posted : September 22, 2023
Last Update Posted : January 30, 2024
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Study Description
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Brief Summary:
This project will be a Randomized clinical trial conducted to check the effect of paraffin wax bath with joint mobilization technique in rehabilitation of post-traumatic stiff knee joint. Study duration will be of 8 months, convenient sampling was done, subject following eligibility criteria from Jinnah Hospital Lahore, will be randomly allocated in two groups, baseline assessment was done, Group A participants were given baseline treatment along with paraffin wax bath therapy and Maitland knee joint mobilization, Group B participants will be given baseline treatment along with Maitland knee joint mobilization. Assessments will done in 4th week and 8th week via, Numeric pain rating scale, goniometer, western Ontario and McMaster universities osteoarthritis index,4 sessions per week will given, data will analyzed by using SPSS version 25.

Condition or disease Intervention/treatment Phase
Knee Pain Chronic Other: Paraffin wax bath therapy and Maitland joint mobilization techniques Other: Maitland knee joint mobilization Not Applicable

Detailed Description:
Knee stiffness is common problem post traumatically due to process of inhibition often occurs in the early post-injury phase. This leads to the initiation of muscle atrophy within hours of the cessation of normal voluntary muscle activation further; this can result in an increase in the viscosity of synovial fluid within the joint, which provides more resistance to motion. Maitland mobilization aims to reestablish the spinning, gliding and rolling motions of the two joints. Although paraffin bath therapy has various effects such as analgesia, reducing chronic inflammation, and increasing connective tissue elasticity, it is non-invasive and has few side effects. Paraffin wax therapy, combined with exercises and the use of splints, has also been found helpful in restoring the range of movement. The current study is to explore the effect of parrafin wax bath therapy in rehabilitation of posttrumatic stiff knee range of motion, pain and functional status, and emphasize the importance of parrafin wax bath therapy adjunct with mobilization technique in treatment of knee stiffness
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Paraffin Wax Bath With Joint Mobilization Technique in Rehabilitation of Post-traumatic Stiff Knee
Actual Study Start Date : September 25, 2023
Actual Primary Completion Date : January 10, 2024
Actual Study Completion Date : January 15, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Paraffin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Paraffin wax bath therapy and Maitland joint mobilization techniques
Paraffin wax bath therapy and Maitland joint mobilization techniques
 Other: Paraffin wax bath therapy and Maitland joint mobilization techniques

In group A Patients will be treated with paraffin wax bath 20 minutes (before any physical therapy treatment)

  • (Apply a few drops of olive oil into the skin of the area. Dip/pour knee joint area into the wax and leave it in for a few seconds until a layer forms over the area. Wait for the wax to dry. Repeat this process until you have at least 10 layers of wax area to be treated.)
  • Joint mobilization technique (8-12 glides at knee joint, mobilization grade-I and grade-II will be used for pain management and relaxation, while grade III for improvement in the PROM at knee joint) will be given 4 times a week for 6 weeks (The patient will be positioned in supine lying with the knee slightly flexed and a prop placed under the distal femur. The stabilizing hand will be used to prop the distal femur and the mobilizing hand is placed over the proximal tibia just below the tibial tuberosity. The mobilization itself will be performed by a force perpendicular to the line of the tibia.)
Active Comparator: Maitland knee joint mobilization
Maitland knee joint mobilization
 Other: Maitland knee joint mobilization

Group B will have (8-12 glides at knee joint, mobilization grade-I and grade-II will be used for pain management and relaxation, while grade III for improvement in the PROM at knee joint) 4 times a week for 6 weeks.

Mobilization procedure will be same as above


Outcome Measures
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Primary Outcome Measures :
  1. NPRS [ Time Frame: 3rd day ]
    Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain

  2. WOMAC [ Time Frame: 3rd day ]
    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 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): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.

  3. Goniometer [ Time Frame: 3rd day ]
    A goniometer is an instrument which measures the available range of motion at a joint.


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 22-40 yrs.
  • Both Male and female
  • Fracture of unilateral knee joint.
  • Subject with 3-6 month after injury
  • Subjects with post traumatic stiffness of knee joint having a minimum of 70º knee flexion

Exclusion Criteria:

  • Recent injuries on knee or on adjacent areas.
  • Neurological problems
  • Subject having polyarthritis, bleeding disorders, tumors, local infection, peripheral vascular disease, leg-length discrepancy of more than one-half inch
  • Any non-traumatic cause of fractures
  • Non traumatic cause of knee stiffness
  • Malignancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06049303


Locations
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Pakistan
Jinnah Hospital Lahore, Rehab Care
Lahore, Punjab, Pakistan
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Syed Shakil ur Rehman Riphah International University, Lahore, Pakistan
More Information
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Publications:
Jawade S, Vardharajulu G, Naidu N. Comparison of effectiveness of hold-relax technique and maitlandfs mobilization in improving range of motion in posttraumatic stiffness of knee joint. Journal of Datta Meghe Institute of Medical Sciences University. 2020;15(3):402.

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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT06049303    
Other Study ID Numbers: REC/RCR&AHS/23/0134 Misbah
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: January 30, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Post-traumatic stiff knee
Range of motion
Pain
Mobilization