Ankle SprainsNCT06168240
The Effect of Manual Lymphatic Drainage on Acute and Post-acute Ankle Sprain in Athletes
A study testing Manual lymphatic drainage. will be applied three days per week for four weeks. in people with Ankle Sprains, run by Sylvia Maher Mohsen Farid Hanna.
Trial summary
Manual lymphatic drainage techniques (MLDTs) are special techniques in manual therapy used in rehabilitation for treatment of physical dysfunctions and pathologies. Such practices could be done by medical team or clinicians. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Ankle Sprains
- What is being tested?
- Manual lymphatic drainage. will be applied three days per week for four weeks.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to May 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- . Basketball Athletes patients diagnosed as acute and post-acute ankle sprain. 2. Patients within 18 and 30 years old. 3. Patients with grade I, II ankle inversion sprain. 4. All participants complains of pain and moderate swelling in the ankle.
Who cannot join
- Previous ankle surgery.
- Serious pathology.
- History of fractures in the ankle joint.
- Vascular disorders.
- Grade III ankle sprain.
About this study
Official title: THE EFFECT OF MANUAL LYMPHATIC DRAINAGE ON ACUTE AND POST-ACUTE ANKLE SPRAIN IN ATHLETES
Manual lymphatic drainage techniques (MLDTs) are special techniques in manual therapy used in rehabilitation for treatment of physical dysfunctions and pathologies. Such practices could be done by medical team or clinicians. Theories on MLDTs address functions like stimulating the lymphatic system by increasing lymph circulation, facilitating the removal of waste products from body tissues, reducing edema, and decreasing the responses of sympathetic nervous system while increasing the parasympathetic nervous tone leading to a relaxed body state.
Read the detailed description
This study will examine the effect of manual lymphatic drainage on pain intensity, ankle swelling, range of motion, static and dynamic functional stability in acute and post-acute ankle sprain in athletes.
Edema treatment includes a variety of techniques; elevation, compression, electrical stimulation, ultrasound, and massage are a few of them. Profound clinical check is required to determine the kind of edema management. However, the effect of these techniques on the lymphatic system and the edema itself is questionable. Manual Lymphatic Drainage mechanism, although still under investigation, is also a valid treatment management that does not cause inflammation, reduces the absorption of waste products and excess fluid and still urges the lymphatic system to work better.
- Conditions
- Ankle Sprains
- Being tested
- Manual lymphatic drainage. will be applied three days per week for four weeks.
- Keywords
- Ankle sprain, Athletes, Manual lymphatic drainage
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual lymphatic drainage. will be applied three days per week for four weeks.Other
Also called Traditional physical therapy program that will include LASER, cold packs, manual mobilization, and exercise program). will applied three days per week for four weeks.
Training will applied 3 days a week, for a total of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | will receive Manual lymphatic drainage plus Traditional physical therapy program that will include LASER, cold packs, manual mobilization, and exercise program. Training will applied 3 days a week, for a total of 4 weeks. Receives: Other: Manual lymphatic drainage. will be applied three days per week for four weeks. |
| group B | Active comparator | will receive Traditional physical therapy program only that will include LASER, cold packs, manual mobilization, and exercise program. Training will applied 3 days a week, for a total of 4 weeks. Receives: Other: Manual lymphatic drainage. will be applied three days per week for four weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
static balance
Flamingo Balance Test to assess static balance
Measured: starting and after 4 weeks
dynamic postural balance
Star Excursion Balance Test to assess dynamic postural balance
Measured: starting and after 4 weeks
Secondary outcomes (3)
Pain intensity
Numeric Pain Rating Scale to assess pain intensity with zero score represents no pain (the better) and ten score represents maximum pain (the worest).
Measured: starting and after 4 weeks
swelling
Figure of Eight with tape measurement by tape measurement to assess swelling in centimeter
Measured: starting and after 4 weeks
range of motion
Goniometer to assess range of motion
Measured: starting and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study startFeb 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SprainsStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sylvia Maher Mohsen Farid Hanna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sylvia Maher Mohsen Farid Hanna, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168240
- Sponsor's protocol ID
- 012/003909
- Status last verified
- Feb 2024
- First submitted
- 20 Nov 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF MANUAL LYMPHATIC DRAINAGE ON ACUTE AND POST-ACUTE ANKLE SPRAIN IN ATHLETES
- ClinicalTrials.gov ID
- NCT06168240
- Acronym / sponsor ID
- 012/003909
- Conditions
- Ankle Sprains
- Keywords
- Ankle sprain, Athletes, Manual lymphatic drainage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sylvia Maher Mohsen Farid HannaUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 13 Dec 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.
Manual lymphatic drainage techniques (MLDTs) are special techniques in manual therapy used in rehabilitation for treatment of physical dysfunctions and pathologies. Such practices could be done by medical team or clinicians. Theories on MLDTs address functions like stimulating the lymphatic system by increasing lymph circulation, facilitating the removal of waste products from body tissues, reducing edema, and decreasing the responses of sympathetic nervous system while increasing the parasympathetic nervous tone leading to a relaxed body state.
Detailed description
This study will examine the effect of manual lymphatic drainage on pain intensity, ankle swelling, range of motion, static and dynamic functional stability in acute and post-acute ankle sprain in athletes.
Edema treatment includes a variety of techniques; elevation, compression, electrical stimulation, ultrasound, and massage are a few of them. Profound clinical check is required to determine the kind of edema management. However, the effect of these techniques on the lymphatic system and the edema itself is questionable. Manual Lymphatic Drainage mechanism, although still under investigation, is also a valid treatment management that does not cause inflammation, reduces the absorption of waste products and excess fluid and still urges the lymphatic system to work better.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Other: Manual lymphatic drainage. will be applied three days per week for four weeks.will receive Manual lymphatic drainage plus Traditional physical therapy program that will include LASER, cold packs, manual mobilization, and exercise program. Training will applied 3 days a week, for a total of 4 weeks. |
| group B | Active comparator | Other: Manual lymphatic drainage. will be applied three days per week for four weeks.will receive Traditional physical therapy program only that will include LASER, cold packs, manual mobilization, and exercise program. Training will applied 3 days a week, for a total of 4 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- . Basketball Athletes patients diagnosed as acute and post-acute ankle sprain. 2. Patients within 18 and 30 years old. 3. Patients with grade I, II ankle inversion sprain. 4. All participants complains of pain and moderate swelling in the ankle.
Key exclusion criteria (5 listed)
- Previous ankle surgery.
- Serious pathology.
- History of fractures in the ankle joint.
- Vascular disorders.
- Grade III ankle sprain.
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 |
|---|---|---|
| Manual lymphatic drainage. will be applied three days per week for four weeks.Also: Traditional physical therapy program that will include LASER, cold packs, manual mobilization, and exercise program). will applied three days per week for four weeks.Training will applied 3 days a week, for a total of 4 weeks. | Other | group A, group B |
Primary outcome
static balance
Time frame: starting and after 4 weeks
Flamingo Balance Test to assess static balance
dynamic postural balance
Time frame: starting and after 4 weeks
Star Excursion Balance Test to assess dynamic postural balance
3 secondary outcomes
Pain intensity
Time frame: starting and after 4 weeks
swelling
Time frame: starting and after 4 weeks
range of motion
Time frame: starting and after 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Manual lymphatic drainage. will be applied three days per week for four weeks. in people with Ankle Sprains, run by Sylvia Maher Mohsen Farid Hanna.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
static balance (time frame: starting and after 4 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?
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 12 Feb 2024.