Contracture, HandNCT06198062
Effects of Paraffin Wax Therapy vs METs in Post Burn Hand Contractures
A study testing Paraffin wax bath therapy and Paraffin Wax Bath Therapy and Muscle Energy Techniques in people with Contracture, Hand, run by Riphah International University at 1 site in Pakistan.
Trial summary
The degree of the burn and the rate of scar development during healing are the main determinants of loss of hand function following thermal injury. Compared to adults, managing these injuries in children presents unique challenges due to three factors: (I) children's thin hand skin makes it difficult to protect deep… Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Contracture, Hand
- What is being tested?
- Paraffin wax bath therapy and Paraffin Wax Bath Therapy and Muscle Energy Techniques
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 5 Feb 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child with age 4 to 12 yrs
- Mild and moderate type of contracture
- Loss up to one third and two third of ranges
- Recently healed wounds to be sure that no open area exist
- Post burn contracture
- Without fragile blistering
Who cannot join
- Severe type of contractures
- Loss of more than two-third of ranges
- Any spinal cord injuries
- Children with rigid spastic contractures
- Contractures other than burn
- Wounds that have open area and risk of bleeding occurs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Paraffin Wax Bath Therapy With and Without Muscle Energy Technique in Children With Post Burn Hand Contracture
The degree of the burn and the rate of scar development during healing are the main determinants of loss of hand function following thermal injury. Compared to adults, managing these injuries in children presents unique challenges due to three factors: (I) children's thin hand skin makes it difficult to protect deep hilar structures; (II) rapid growth of the hand and fingers in the second and third years of life can cause contusion scar deformity; and (III) treatment is frequently challenging due to the young child's lack of cooperation. The manual technique known as Muscle Energy Technique (MET) primarily targets the soft tissues, although it also has significant effects on the muscles. Osteopaths and is currently utilized by a variety of manual therapy professions as a contribution to joint mobilization. This method is also known as the active muscular relaxation technique or the muscle energy technique. Exercise is necessary to maintain mobility, which in turn depends on overcoming dryness and decreased suppleness of the scar tissue across the joint, which in turn depends on preventing joint stiffness. Heat therapy for the relief of joint pain and stiffness was established using paraffin and prolonged stretching. When used as a treatment method, paraffin wax is heated to a temperature between 115 and 118 degrees.
Read the detailed description
The degree of the burn and the rate of scar development during healing are the main determinants of loss of hand function following thermal injury. Compared to adults, managing these injuries in children presents unique challenges due to three factors: (I) children's thin hand skin makes it difficult to protect deep hilar structures; (II) rapid growth of the hand and fingers in the second and third years of life can cause contusion scar deformity; and (III) treatment is frequently challenging due to the young child's lack of cooperation. The manual technique known as Muscle Energy Technique (MET) primarily targets the soft tissues, although it also has significant effects on the muscles. Osteopaths and is currently utilized by a variety of manual therapy professions as a contribution to joint mobilization. This method is also known as the active muscular relaxation technique or the muscle energy technique. Exercise is necessary to maintain mobility, which in turn depends on overcoming dryness and decreased suppleness of the scar tissue across the joint, which in turn depends on preventing joint stiffness. Heat therapy for the relief of joint pain and stiffness was established using paraffin and prolonged stretching. When used as a treatment method, paraffin wax is heated to a temperature between 115 and 118 degrees.
It will be randomized controlled trail. In which convenient sampling technique will be used. Two groups will be formed in which participants will be divided by lottery method. Group A will be treated by paraffin wax bath therapy and Group B treated by paraffin wax bath therapy with muscle energy technique. The result after statistical analysis will either show this intervention is effective or not. Result will be analyzed on SPSS
- Conditions
- Contracture, Hand
- Being tested
- Paraffin wax bath therapy, Paraffin Wax Bath Therapy and Muscle Energy Techniques
- Keywords
- Paraffin wax, METS, Contracture, Burn
- Medical subject headings
- Contracture, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paraffin wax bath therapyOther
this group receive paraffin wax. Each session will last between 40 and 50 min, 2 sessions per week, for total 6 weeks
Paraffin Wax Bath Therapy and Muscle Energy TechniquesOther
This group receive paraffin wax bath therapy along with muscle energy techniques. Each session will be conducted for 40 to 50 mins, 3 sessions in a week for total 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Paraffin wax bath therapy | Experimental | Heat therapy for the relief of joint pain and stiffness was established using paraffin and prolonged stretching. When used as a treatment method, paraffin wax is heated to a temperature between 115 and 118 degrees. One step of the paraffin treatment is cleaning. (1) Drying the damaged area and making sure the skin is covered in plastic, (2) Wrapping any small open wounds in plastic, (3) Applying paraffin wax to the affected area, (4) Stretching the affected extremity for 20 minutes, (5)Covering the area with an ACE bandage or a towel to prevent the wax from cooling too quickly Receives: Other: Paraffin wax bath therapy |
| Muscle energy technique | Experimental | Reciprocal inhibition, hypertonic antagonists can reflexively inhibiting their agonist muscle. Therefore, in the presence of short and tight antagonist muscles, restoring normal muscle tone and length should be first addressed. MET involves the subject to voluntarily contract the muscle in a precisely controlled direction against the therapist's counter force. Its therapeutic effects are to reduce pain, reduce muscle tone, stretch tightened muscles, strengthen the weak muscles, improve local circulation and mobilize joint restrictions. Anatomical structures that contribute to stiffness at the joint states that the joint capsule, surrounding inter-muscular fasciae and muscles, tendons and skin tissue account for restriction at the joint. Relaxation of the antagonist muscle occurs due to actively contracting the agonist muscle Receives: Other: Paraffin Wax Bath Therapy and Muscle Energy Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goniometer
Measuring a joint angle with a universal goniometer has moderate to excellent reliability. It can therefore, be used as a repeatable device for measuring the range of motion of the joint. According to an article the inter-tester reliability of goniometer is 0.98 and ICC is 0.99 and validity 0.97-0.98. The results of this study indicates that goniometric measurement are both valid and reliable.
Measured: 6 weeks
ABILHAND-kids Questionnaires
ABILHAND-Kids is use to measure the manual ability of hand in children. The scale used for face to face interview of the parents of the child. The interview will be conduct twice. On the first visit and after an interval of 15 days. The scale consist of different activities parents are asked to fill the questionnaire by estimating their child difficulty on three levels.
Impossible: the child is unable to perform the activity.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Dec 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contracture, HandStudies 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
- Model description
- This will be randomized control trail to see effects of Paraffin wax bath therapy with and without muscle energy technique in children with post burn hand contracture
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aiman Arif, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198062
- Sponsor's protocol ID
- REC/RCR&AHS/23/0736
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34336391
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Paraffin Wax Bath Therapy With and Without Muscle Energy Technique in Children With Post Burn Hand Contracture
- ClinicalTrials.gov ID
- NCT06198062
- Acronym / sponsor ID
- REC/RCR&AHS/23/0736
- Conditions
- Contracture, Hand
- Keywords
- Paraffin wax, METS, Contracture, Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 10 Jan 2024 (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.
The degree of the burn and the rate of scar development during healing are the main determinants of loss of hand function following thermal injury. Compared to adults, managing these injuries in children presents unique challenges due to three factors: (I) children's thin hand skin makes it difficult to protect deep hilar structures; (II) rapid growth of the hand and fingers in the second and third years of life can cause contusion scar deformity; and (III) treatment is frequently challenging due to the young child's lack of cooperation. The manual technique known as Muscle Energy Technique (MET) primarily targets the soft tissues, although it also has significant effects on the muscles. Osteopaths and is currently utilized by a variety of manual therapy professions as a contribution to joint mobilization. This method is also known as the active muscular relaxation technique or the muscle energy technique. Exercise is necessary to maintain mobility, which in turn depends on overcoming dryness and decreased suppleness of the scar tissue across the joint, which in turn depends on preventing joint stiffness. Heat therapy for the relief of joint pain and stiffness was established using paraffin and prolonged stretching. When used as a treatment method, paraffin wax is heated to a temperature between 115 and 118 degrees.
Detailed description
The degree of the burn and the rate of scar development during healing are the main determinants of loss of hand function following thermal injury. Compared to adults, managing these injuries in children presents unique challenges due to three factors: (I) children's thin hand skin makes it difficult to protect deep hilar structures; (II) rapid growth of the hand and fingers in the second and third years of life can cause contusion scar deformity; and (III) treatment is frequently challenging due to the young child's lack of cooperation. The manual technique known as Muscle Energy Technique (MET) primarily targets the soft tissues, although it also has significant effects on the muscles. Osteopaths and is currently utilized by a variety of manual therapy professions as a contribution to joint mobilization. This method is also known as the active muscular relaxation technique or the muscle energy technique. Exercise is necessary to maintain mobility, which in turn depends on overcoming dryness and decreased suppleness of the scar tissue across the joint, which in turn depends on preventing joint stiffness. Heat therapy for the relief of joint pain and stiffness was established using paraffin and prolonged stretching. When used as a treatment method, paraffin wax is heated to a temperature between 115 and 118 degrees.
It will be randomized controlled trail. In which convenient sampling technique will be used. Two groups will be formed in which participants will be divided by lottery method. Group A will be treated by paraffin wax bath therapy and Group B treated by paraffin wax bath therapy with muscle energy technique. The result after statistical analysis will either show this intervention is effective or not. Result will be analyzed on SPSS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This will be randomized control trail to see effects of Paraffin wax bath therapy with and without muscle energy technique in children with post burn hand contracture
| Arm | Type | Receives |
|---|---|---|
| Paraffin wax bath therapy | Experimental | Other: Paraffin wax bath therapyHeat therapy for the relief of joint pain and stiffness was established using paraffin and prolonged stretching. When used as a treatment method, paraffin wax is heated to a temperature between 115 and 118 degrees. One step of the paraffin treatment is cleaning. (1) Drying the damaged area and making sure the skin is covered in plastic, (2) Wrapping any small open wounds in plastic, (3) Applying paraffin wax to the affected area, (4) Stretching the affected extremity for 20 minutes, (5)Covering the area with an ACE bandage or a towel to prevent the wax from cooling too quickly |
| Muscle energy technique | Experimental | Other: Paraffin Wax Bath Therapy and Muscle Energy TechniquesReciprocal inhibition, hypertonic antagonists can reflexively inhibiting their agonist muscle. Therefore, in the presence of short and tight antagonist muscles, restoring normal muscle tone and length should be first addressed. MET involves the subject to voluntarily contract the muscle in a precisely controlled direction against the therapist's counter force. Its therapeutic effects are to reduce pain, reduce muscle tone, stretch tightened muscles, strengthen the weak muscles, improve local circulation and mobilize joint restrictions. Anatomical structures that contribute to stiffness at the joint states that the joint capsule, surrounding inter-muscular fasciae and muscles, tendons and skin tissue account for restriction at the joint. Relaxation of the antagonist muscle occurs due to actively contracting the agonist muscle |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child with age 4 to 12 yrs
- Mild and moderate type of contracture
- Loss up to one third and two third of ranges
- Recently healed wounds to be sure that no open area exist
- Post burn contracture
Key exclusion criteria (6 listed)
- Severe type of contractures
- Loss of more than two-third of ranges
- Any spinal cord injuries
- Children with rigid spastic contractures
- Contractures other than burn
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 therapythis group receive paraffin wax. Each session will last between 40 and 50 min, 2 sessions per week, for total 6 weeks | Other | Paraffin wax bath therapy |
| Paraffin Wax Bath Therapy and Muscle Energy TechniquesThis group receive paraffin wax bath therapy along with muscle energy techniques. Each session will be conducted for 40 to 50 mins, 3 sessions in a week for total 6 weeks | Other | Muscle energy technique |
Primary outcome
Goniometer
Time frame: 6 weeks
Measuring a joint angle with a universal goniometer has moderate to excellent reliability. It can therefore, be used as a repeatable device for measuring the range of motion of the joint. According to an article the inter-tester reliability of goniometer is 0.98 and ICC is 0.99 and validity 0.97-0.98. The results of this study indicates that goniometric measurement are both valid and reliable.
ABILHAND-kids Questionnaires
Time frame: 6 weeks
ABILHAND-Kids is use to measure the manual ability of hand in children. The scale used for face to face interview of the parents of the child. The interview will be conduct twice. On the first visit and after an interval of 15 days. The scale consist of different activities parents are asked to fill the questionnaire by estimating their child difficulty on three levels. Impossible: the child is unable to perform the activity.
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 13 Jun 2024.
- 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.
- 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.
Aiman Arif, MS* principal investigator
Riphah International University
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 Paraffin Wax Bath Therapy and Muscle Energy Techniques in people with Contracture, Hand, 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 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: finished, as of the sponsor's last update on 13 Jun 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?
Goniometer (time frame: 6 weeks). 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?
On the ClinicalTrials.gov record for NCT06198062, which also lists 1 linked publication.
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 13 Jun 2024.