Stiffness; SacroiliacNCT06913439
Fin Wax Bath Therapy in Patients With Post-traumatic Stiffness of Knee Joint: A Randomized Controlled Trial
A study testing Exercise Group and Parafin Wax Bath in people with Stiffness; Sacroiliac, run by Superior University at 1 site in Pakistan.
Trial summary
Knee traumas termed as any injury or damage to the knee's joint which is caused by different factors like sports injury, accidents and by fall .Knee stiffness is a common complication of femoral and tibia fracture and injuries to the extensor mechanism of the knee. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Stiffness; Sacroiliac
- What is being tested?
- Exercise Group and Parafin Wax Bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-40 years.
- Both Male and female
- Fracture of the unilateral knee joint and around the knee managed with conservative treatment only.
- Subjects with post-traumatic stiffness of knee joint having a minimum of 70º knee flexion.
- Able to walk independently or with minimal assistance.
- Administer patient in study after 12 weeks of knee injury.
Who cannot join
- deformity of hip and knee.
- Implant at fracture and around fracture site.
- Subject having polyarthritis, bleeding disorders, tumors, local infection, peripheral vascular disease, leg-length discrepancy of more than one-half inch.
- History of knee replacement or other knee surgeries within the last six months.
- Presence of neurological conditions (e.g., stroke, multiple sclerosis) affecting gait or knee mobility.
- Known allergy or intolerance to paraffin wax therapy or other study interventions."
Trial locations and contacts
1 site in 1 country.
About this study
Knee traumas termed as any injury or damage to the knee's joint which is caused by different factors like sports injury, accidents and by fall .Knee stiffness is a common complication of femoral and tibia fracture and injuries to the extensor mechanism of the knee.
Read the detailed description
There are many types of trauma of knee joint such as anterior cruciate ligament (ACL) tear, posterior cruciate ligament (PCL) tears, medial collateral ligament (MCL) tear, lateral collateral ligament (LCL) tear and meniscal tears etc. Post-traumatic knee stiffness is a commonest problem after knee injuries or surgical procedure. It affects significantly patient's quality of life and making daily living activities challenging. Paraffin wax bath therapy involves soaking targeted area in a warm paraffin wax bath pour hot liquid form wax on target area.The heat from the wax increase blood circulation in the affected areas. Mobilization with Movement (MWM) is a type manual therapy technique includes combination of joint mobilization with movement to improve joint mobility, decrease pain and improve functional ability. MWM play a role of application of joint mobilization and active movement simultaneously. The researcher employs a randomized controlled trial methodology.
- Conditions
- Stiffness; Sacroiliac
- Being tested
- Exercise Group, Parafin Wax Bath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise GroupDiagnostic test
technique was implemented with three sets of ten repetitions on each treatment occasion for a period of 3 days/ week for 8 weeks. In this group, the adjustable couch was used to treat the patients effectively. During MWM, position of the patients was prone lying and high sitting position with swinging bilateral leg out of the couch at available various range of motion of affected knee joint. In prone lying position, the therapist was stand just behind the patient towards the affected knee joint. The mulligan belt placed at proximal tibia ends which already wrapped with the lower back of the therapist. In high or couch sitting position, the therapist was sitting on rest chair. The method using of mulligan belt was same as in prone lying position. After stabilization, the mobilization with movement (MWM) started in order with the therapist mobilized the knee joint followed by active movement of knee joint performed by the patients
Parafin Wax BathCombination product
Group B will receive Paraffin Wax Bath Therapy in combination with standard care exercises. In this treatment, the affected knee joint will be immersed in warm paraffin wax to deliver thermotherapy, which helps reduce joint stiffness, improve circulation, and enhance joint mobility. Each paraffin wax session will last 15-20 minutes. Following the thermotherapy, participants will perform standard care exercises targeting knee mobility, flexibility, and strength. These sessions will also occur 3 times per week over a period of 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Active comparator | Not described Receives: Diagnostic Test: Exercise Group |
| Parafin Wax Bath | Experimental | Not described Receives: Combination Product: Parafin Wax Bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
VISUAL ANALOG SCALE (VAS)
The Visual Analogue Scale (VAS) uses a 10 cm line with anchors like "no pain" and "worst pain imaginable", and the score is determined by measuring the distance (in mm or cm) from the "no pain" end to the patient's mark, ranging from 0 to 100
Measured: 12 Months
OSTEOARTHRITS INDEX (WOMAC)
The Oswestry Disability Index (ODI) is a questionnaire used to assess functional disability in individuals with low back pain, with scores ranging from 0% (no disability) to 100% (maximum disability), and interpreted as follows: 0-20% minimal disability, 21-40% moderate, 41-60% severe, 61-80% crippling, and 81-100% bed-bound or exaggerated symptoms
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stiffness; SacroiliacStudies of the same condition, open and under way.
- More trials run by Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913439
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/799
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fin Wax Bath Therapy in Patients With Post-traumatic Stiffness of Knee Joint: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06913439
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/799
- Conditions
- Stiffness; Sacroiliac
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 Apr 2025 (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.
Knee traumas termed as any injury or damage to the knee's joint which is caused by different factors like sports injury, accidents and by fall .Knee stiffness is a common complication of femoral and tibia fracture and injuries to the extensor mechanism of the knee.
Detailed description
There are many types of trauma of knee joint such as anterior cruciate ligament (ACL) tear, posterior cruciate ligament (PCL) tears, medial collateral ligament (MCL) tear, lateral collateral ligament (LCL) tear and meniscal tears etc. Post-traumatic knee stiffness is a commonest problem after knee injuries or surgical procedure. It affects significantly patient's quality of life and making daily living activities challenging. Paraffin wax bath therapy involves soaking targeted area in a warm paraffin wax bath pour hot liquid form wax on target area.The heat from the wax increase blood circulation in the affected areas. Mobilization with Movement (MWM) is a type manual therapy technique includes combination of joint mobilization with movement to improve joint mobility, decrease pain and improve functional ability. MWM play a role of application of joint mobilization and active movement simultaneously. The researcher employs a randomized controlled trial methodology.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Active comparator | Diagnostic Test: Exercise Group |
| Parafin Wax Bath | Experimental | Combination Product: Parafin Wax Bath |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-40 years.
- Both Male and female
- Fracture of the unilateral knee joint and around the knee managed with conservative treatment only.
- Subjects with post-traumatic stiffness of knee joint having a minimum of 70º knee flexion.
- Able to walk independently or with minimal assistance.
Key exclusion criteria (6 listed)
- deformity of hip and knee.
- Implant at fracture and around fracture site.
- Subject having polyarthritis, bleeding disorders, tumors, local infection, peripheral vascular disease, leg-length discrepancy of more than one-half inch.
- History of knee replacement or other knee surgeries within the last six months.
- Presence of neurological conditions (e.g., stroke, multiple sclerosis) affecting gait or knee mobility.
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 |
|---|---|---|
| Exercise Grouptechnique was implemented with three sets of ten repetitions on each treatment occasion for a period of 3 days/ week for 8 weeks. In this group, the adjustable couch was used to treat the patients effectively. During MWM, position of the patients was prone lying and high sitting position with swinging bilateral leg out of the couch at available various range of motion of affected knee joint. In prone lying position, the therapist was stand just behind the patient towards the affected knee joint. The mulligan belt placed at proximal tibia ends which already wrapped with the lower back of the therapist. In high or couch sitting position, the therapist was sitting on rest chair. The method using of mulligan belt was same as in prone lying position. After stabilization, the mobilization with movement (MWM) started in order with the therapist mobilized the knee joint followed by active movement of knee joint performed by the patients | Diagnostic test | Exercise Group |
| Parafin Wax BathGroup B will receive Paraffin Wax Bath Therapy in combination with standard care exercises. In this treatment, the affected knee joint will be immersed in warm paraffin wax to deliver thermotherapy, which helps reduce joint stiffness, improve circulation, and enhance joint mobility. Each paraffin wax session will last 15-20 minutes. Following the thermotherapy, participants will perform standard care exercises targeting knee mobility, flexibility, and strength. These sessions will also occur 3 times per week over a period of 8 weeks. | Combination product | Parafin Wax Bath |
Primary outcome
VISUAL ANALOG SCALE (VAS)
Time frame: 12 Months
The Visual Analogue Scale (VAS) uses a 10 cm line with anchors like "no pain" and "worst pain imaginable", and the score is determined by measuring the distance (in mm or cm) from the "no pain" end to the patient's mark, ranging from 0 to 100
OSTEOARTHRITS INDEX (WOMAC)
Time frame: 12 Months
The Oswestry Disability Index (ODI) is a questionnaire used to assess functional disability in individuals with low back pain, with scores ranging from 0% (no disability) to 100% (maximum disability), and interpreted as follows: 0-20% minimal disability, 21-40% moderate, 41-60% severe, 61-80% crippling, and 81-100% bed-bound or exaggerated symptoms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Group and Parafin Wax Bath in people with Stiffness; Sacroiliac, run by Superior 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 6 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
VISUAL ANALOG SCALE (VAS) (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2025.