Knee Pain ChronicNCT06049303
Paraffin Wax Bath With Joint Mobilization Technique in Post-traumatic Stiff Knee
A study testing Paraffin wax bath therapy and Maitland joint mobilization techniques and Maitland knee joint mobilization in people with Knee Pain Chronic, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 22 to 40 years
- Conditions the study is for
- Knee Pain Chronic
- What is being tested?
- Paraffin wax bath therapy and Maitland joint mobilization techniques and Maitland knee joint mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Sep 2023to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Paraffin Wax Bath With Joint Mobilization Technique in Rehabilitation of Post-traumatic Stiff Knee
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.
Read the 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
- Conditions
- Knee Pain Chronic
- Being tested
- Paraffin wax bath therapy and Maitland joint mobilization techniques, Maitland knee joint mobilization
- Keywords
- Post-traumatic stiff knee, Range of motion, Pain, Mobilization
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paraffin wax bath therapy and Maitland joint mobilization techniquesOther
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 mobilizationOther
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 group | Role | What they receive |
|---|---|---|
| Paraffin wax bath therapy and Maitland joint mobilization techniques | Experimental | Paraffin wax bath therapy and Maitland joint mobilization techniques Receives: Other: Paraffin wax bath therapy and Maitland joint mobilization techniques |
| Maitland knee joint mobilization | Active comparator | Maitland knee joint mobilization Receives: Other: Maitland knee joint mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3rd day
Goniometer
A goniometer is an instrument which measures the available range of motion at a joint.
Measured: 3rd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start25 Sep 2023
- Primary completion10 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Knee Pain ChronicStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil ur Rehman, Principal investigator, Riphah International University, Lahore, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049303
- Sponsor's protocol ID
- REC/RCR&AHS/23/0134 Misbah
- Status last verified
- Jan 2024
- First submitted
- 15 Sep 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29861257Jawade 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.
PubMed 36914488Riaz 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.
PubMed 34336391Borrell 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.
PubMed 7443789Kaneguchi 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.
PubMed 27601089Simas 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.
PubMed 26761556Rao 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.
PubMed 30100279Weleslassie 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.
PubMed 34055123Plummer 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.
PubMed 35728804
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Paraffin Wax Bath With Joint Mobilization Technique in Rehabilitation of Post-traumatic Stiff Knee
- ClinicalTrials.gov ID
- NCT06049303
- Acronym / sponsor ID
- REC/RCR&AHS/23/0134 Misbah
- Conditions
- Knee Pain Chronic
- Keywords
- Post-traumatic stiff knee, Range of motion, Pain, Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paraffin wax bath therapy and Maitland joint mobilization techniques | Experimental | Other: Paraffin wax bath therapy and Maitland joint mobilization techniquesParaffin wax bath therapy and Maitland joint mobilization techniques |
| Maitland knee joint mobilization | Active comparator | Other: Maitland knee joint mobilizationMaitland knee joint mobilization |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paraffin wax bath therapy and Maitland joint mobilization techniquesIn 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 | Paraffin wax bath therapy and Maitland joint mobilization techniques |
| Maitland knee joint mobilizationGroup 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 | Other | Maitland knee joint mobilization |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 29861257Balasundaram 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.
- BackgroundJawade 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: PubMed 36914488Kim 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.
- Background: PubMed 34336391Riaz 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.
- Background: PubMed 7443789Borrell 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.
- Background: PubMed 27601089Kaneguchi 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.
- Background: PubMed 26761556Simas 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.
- Background: PubMed 30100279Rao 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.
- Background: PubMed 34055123Weleslassie 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.
- Background: PubMed 35728804Plummer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed Shakil ur Rehman principal investigator
Riphah International University, Lahore, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paraffin wax bath therapy and Maitland joint mobilization techniques and Maitland knee joint mobilization in people with Knee Pain Chronic, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPRS (time frame: 3rd day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06049303, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.