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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06049303
Other study ID # REC/RCR&AHS/23/0134 Misbah
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 25, 2023
Est. completion date January 15, 2024

Study information

Verified date January 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date January 15, 2024
Est. primary completion date January 10, 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years to 40 Years
Eligibility 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 70ยบ 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

Study Design


Related Conditions & MeSH terms


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.)
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

Locations

Country Name City State
Pakistan Jinnah Hospital Lahore, Rehab Care Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary NPRS 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 3rd day
Primary WOMAC 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. 3rd day
Primary Goniometer A goniometer is an instrument which measures the available range of motion at a joint. 3rd day
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