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

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

Tracking Information

• First Submitted Date: September 15, 2023
• First Posted Date: September 22, 2023
• Last Update Posted Date: January 30, 2024
• Actual Study Start Date: September 25, 2023
• Actual Primary Completion Date: January 10, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 15, 2023)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Paraffin Wax Bath With Joint Mobilization Technique in Post-traumatic Stiff Knee
• Official Title: Effects of Paraffin Wax Bath With Joint Mobilization Technique in Rehabilitation of Post-traumatic Stiff Knee
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Knee Pain Chronic

Intervention

• 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.)
• 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

Study Arms

• Experimental: Paraffin wax bath therapy and Maitland joint mobilization techniques
  Paraffin wax bath therapy and Maitland joint mobilization techniques
  Intervention: Other: Paraffin wax bath therapy and Maitland joint mobilization techniques
• Active Comparator: Maitland knee joint mobilization
  Maitland knee joint mobilization
  Intervention: Other: Maitland knee joint mobilization

Publications *

• Balasundaram AP, Sreerama Rajan S. Short-term effects of mobilisation with movement in patients with post-traumatic stiffness of the knee joint. J Bodyw Mov Ther. 2018 Apr;22(2):498-501. doi: 10.1016/j.jbmt.2017.06.007. Epub 2017 Jun 15.
• 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.
• Kim SG, Kang JW, Boo JH, Jin DU, Choi SJ, Song GG, Jung JH. Effectiveness of paraffin bath therapy for the symptoms and function of hand diseases: A systematic review and meta-analysis of randomized controlled trials. J Hand Ther. 2023 Jul-Sep;36(3):706-712. doi: 10.1016/j.jht.2022.10.005. Epub 2023 Mar 12.
• Riaz HM, Ashraf Cheema S. Paraffin wax bath therapy versus therapeutic ultrasound in management of post burn contractures of small joints of hand. Int J Burns Trauma. 2021 Jun 15;11(3):245-250. eCollection 2021.
• Borrell RM, Parker R, Henley EJ, Masley D, Repinecz M. Comparison of in vivo temperatures produced by hydrotherapy, paraffin wax treatment, and Fluidotherapy. Phys Ther. 1980 Oct;60(10):1273-6. doi: 10.1093/ptj/60.10.1273.
• Kaneguchi A, Ozawa J, Kawamata S, Yamaoka K. Development of arthrogenic joint contracture as a result of pathological changes in remobilized rat knees. J Orthop Res. 2017 Jul;35(7):1414-1423. doi: 10.1002/jor.23419. Epub 2017 Mar 23.
• Simas JM, Kunz RI, Brancalhao RM, Ribeiro Lde F, Bertolini GR. Effects of physical exercise on the cartilage of ovariectomized rats submitted to immobilization. Einstein (Sao Paulo). 2015 Oct-Dec;13(4):574-9. doi: 10.1590/S1679-45082015AO3418.
• Rao RV, Balthillaya G, Prabhu A, Kamath A. Immediate effects of Maitland mobilization versus Mulligan Mobilization with Movement in Osteoarthritis knee- A Randomized Crossover trial. J Bodyw Mov Ther. 2018 Jul;22(3):572-579. doi: 10.1016/j.jbmt.2017.09.017. Epub 2017 Sep 28.
• Weleslassie GG, Temesgen MH, Alamer A, Tsegay GS, Hailemariam TT, Melese H. Effectiveness of Mobilization with Movement on the Management of Knee Osteoarthritis: A Systematic Review of Randomized Controlled Trials. Pain Res Manag. 2021 May 3;2021:8815682. doi: 10.1155/2021/8815682. eCollection 2021.
• Plummer S, Leonard J. Mobilization With Movement as Therapy to Reduce Knee Pain and Increase Knee Range of Motion. J Sport Rehabil. 2022 Jun 20;31(7):950-953. doi: 10.1123/jsr.2021-0294. Print 2022 Sep 1.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 15, 2023): 34
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 15, 2024
• Actual Primary Completion Date: January 10, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Pakistan

Administrative Information

• NCT Number: NCT06049303
• Other Study ID Numbers: REC/RCR&AHS/23/0134 Misbah
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Riphah International University
• Original Responsible Party: Same as current
• Current Study Sponsor: Riphah International University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Syed Shakil ur Rehman; Riphah International University, Lahore, Pakistan

• PRS Account: Riphah International University
• Verification Date: January 2024