NCT06049303

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

September 15, 2023

Last Update Submit

January 28, 2024

Conditions

Keywords

Post-traumatic stiff kneeRange of motionPainMobilization

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Goniometer

    A goniometer is an instrument which measures the available range of motion at a joint.

    3rd day

Study Arms (2)

Paraffin wax bath therapy and Maitland joint mobilization techniques

EXPERIMENTAL

Paraffin wax bath therapy and Maitland joint mobilization techniques

Other: Paraffin wax bath therapy and Maitland joint mobilization techniques

Maitland knee joint mobilization

ACTIVE COMPARATOR

Maitland knee joint mobilization

Other: Maitland knee joint mobilization

Interventions

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.)

Paraffin wax bath therapy and Maitland joint mobilization techniques

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

Maitland knee joint mobilization

Eligibility Criteria

Age22 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital Lahore, Rehab Care

Lahore, Punjab Province, Pakistan

Location

Related 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.

    PMID: 29861257BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 36914488BACKGROUND
  • 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.

    PMID: 34336391BACKGROUND
  • 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.

    PMID: 7443789BACKGROUND
  • 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.

    PMID: 27601089BACKGROUND
  • 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.

    PMID: 26761556BACKGROUND
  • 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.

    PMID: 30100279BACKGROUND
  • 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.

    PMID: 34055123BACKGROUND
  • 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.

    PMID: 35728804BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Syed Shakil ur Rehman

    Riphah International University, Lahore, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 22, 2023

Study Start

September 25, 2023

Primary Completion

January 10, 2024

Study Completion

January 15, 2024

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations