Lateral EpicondylitisIASTMNCT05780528
Mulligan Mobilization Versus Instrument Assissted Soft Tissue Mobilization In Chronic Iateral Epicondylitis
A study testing mulligan mobilization, instrumented assisted soft tissue mobilization and conventional treatment in people with Lateral Epicondylitis, run by Cairo University.
Trial summary
this study will be conducted to compare between mulligan mobilization and instrument assisted soft tissue mobilization on pain intensity, range of motion, hand grip strength, and hand function in the treatment of chronic lateral epicondylitis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- mulligan mobilization, instrumented assisted soft tissue mobilization and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2023to 30 Jun 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients will be diagnosed with chronic lateral epicondylitis from both genders.
- Patients with chronic lateral epicondylitis were diagnosed by orthopedists. Positive clinical manifestation in all patients. Patients' age will be ranged from 18 to 80 years, Pain onset is more than 3 months. All participants must be medically stable and not be treated with analgesics or any medication which may cause misleading results.
- All patients have a body mass index between 18.5 and 29.9 kg/m2.
Who cannot join
- Patients who received an intra-articular injection for a duration of less than 3 months.
- Patients receiving oral or injected corticosteroids for the last 3 months at least.
- History of elbow surgery/fracture. Acute synovitis/arthritis including infectious. Presence of malignancy. Pregnancy. Patients with, topical lesions, contact dermatitis, and a history of cutaneous hypersensitivity
About this study
Official title: Mulligan Mobilization Versus Instrument Assissted Soft Tissue Mobilization In The Treatment Of Chronic Iateral Epicondylitis
this study will be conducted to compare between mulligan mobilization and instrument assisted soft tissue mobilization on pain intensity, range of motion, hand grip strength, and hand function in the treatment of chronic lateral epicondylitis
Read the detailed description
Lateral epicondylitis is one of the elbow conditions that affects about 1-3% of the population at large. It produces a heavy burden of workdays lost and residual impairments. Although many treatment modalities are used, few of them rest on scientific evidence and none has been proven more effective than the others. This lack of evidence on treatments for lateral epicondylitis may stem from several sources, including the possible self-limiting nature of the condition, the lack of pathophysiological data, the methodological shortcomings of available studies, and the existence of numerous factors influencing the outcome. The physiotherapeutic treatment has been shown to be effective. In general, it must include manual therapy to relieve the pain and improve the joint's range of motion (ROM), taking into account that it must be performed under the pain threshold. Mulligan mobilization with movement (MWM) is a modern technique developed by Mulligan for treating lateral epicondylitis (LE). Instrument-assisted soft tissue mobilization is a form of augmented soft tissue mobilization (IASTM) in which stainless steel instruments are utilized to apply controlled microtrauma to the affected soft tissues. sixty patients will be allocated randomly to three groups; the first one will receive mulligan mobilization with movement, the second one will receive instrument-assisted soft tissue mobilization and the third one will receive traditional therapy three times a week for four weeks
- Conditions
- Lateral Epicondylitis
- Being tested
- mulligan mobilization, instrumented assisted soft tissue mobilization, conventional treatment
- Keywords
- instrumented assisted soft tissue mobilization, Mulligan Mobilization, lateral epiconylitis
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mulligan mobilizationOther
The patients will receive mobilization with movement technique of lateral glide. the patients will be in supine subject and pronate forearm, during the application of the lateral glide by the physiotherapist, each patient was asked to perform the closure of the fist (provocative but painless gesture in the execution of the technique) for 3 sets of 10 repetitions.
instrumented assisted soft tissue mobilizationOther
the participant will receive instrumented assisted soft tissue mobilization. The participant's elbow will rest on a table. A lubricant (Vaseline) will be applied to the skin around the elbow prior to treatment and the blade will be cleaned with an alcohol pad. First, the blade will be used to find the exact areas of restriction in the common extensor origin. Then the M2T blade will be used in the treatment planes 1, 2, and 3, to apply slow strokes along the muscle, without causing any discomfort or pain, from the muscle origin to its insertion (sweeping technique)
conventional treatmentOther
the patients will receive conventional treatment in the form of Ultrasound therapy, conventional transcutaneous electrical nerve stimulation (TENS) - hot pack - stretching and strengthening exercises and wrist rest splints
| Study group | Role | What they receive |
|---|---|---|
| mulligan mobilization | Experimental | the patients will receive mulligan mobilization three times a week for four weeks Receives: Other: mulligan mobilization; Other: conventional treatment |
| instrumented assisted soft tissue mobilization | Experimental | the patients will receive instrumented assisted soft tissue mobilization three times a week for four weeks Receives: Other: instrumented assisted soft tissue mobilization; Other: conventional treatment |
| conventional treatment | Active comparator | the patients will receive conventional treatment three times a week for four weeks Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
pain will be measured by visual analogue scale. It is a vertical or horizontal 100 mm line graduated by different levels of pain, starting from 0 (no pain) till 100 (worst pain)
Measured: up to four weeks
shoulder disability
The Arabic version of Disabilities of arm, shoulder, and hand (DASH) will be used for assessing shoulder function.DASH questionnaire includes 11 items with score from 0 to 100. A score of 0 represents no disability, while a score of 100 represents the most sever
Measured: up to four weeks
Secondary outcomes (2)
range of motion
elbow and wrist range of motion will be measured by universal goniometer
Measured: up to four weeks
hand grip strength
Hand held dynamometer will be used to measure hand grip strength
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start25 Mar 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- mulligan mobilization and instrumented-assisted soft tissue mobilization
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Yehia Helmy Abdelrahem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780528
- Sponsor's protocol ID
- P.T.REC/012/004235
- Acronym
- IASTM
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mulligan Mobilization Versus Instrument Assissted Soft Tissue Mobilization In The Treatment Of Chronic Iateral Epicondylitis
- ClinicalTrials.gov ID
- NCT05780528
- Acronym / sponsor ID
- IASTM / P.T.REC/012/004235
- Conditions
- Lateral Epicondylitis
- Keywords
- instrumented assisted soft tissue mobilization, Mulligan Mobilization, lateral epiconylitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Mar 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 22 Mar 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 study will be conducted to compare between mulligan mobilization and instrument assisted soft tissue mobilization on pain intensity, range of motion, hand grip strength, and hand function in the treatment of chronic lateral epicondylitis
Detailed description
Lateral epicondylitis is one of the elbow conditions that affects about 1-3% of the population at large. It produces a heavy burden of workdays lost and residual impairments. Although many treatment modalities are used, few of them rest on scientific evidence and none has been proven more effective than the others. This lack of evidence on treatments for lateral epicondylitis may stem from several sources, including the possible self-limiting nature of the condition, the lack of pathophysiological data, the methodological shortcomings of available studies, and the existence of numerous factors influencing the outcome. The physiotherapeutic treatment has been shown to be effective. In general, it must include manual therapy to relieve the pain and improve the joint's range of motion (ROM), taking into account that it must be performed under the pain threshold. Mulligan mobilization with movement (MWM) is a modern technique developed by Mulligan for treating lateral epicondylitis (LE). Instrument-assisted soft tissue mobilization is a form of augmented soft tissue mobilization (IASTM) in which stainless steel instruments are utilized to apply controlled microtrauma to the affected soft tissues. sixty patients will be allocated randomly to three groups; the first one will receive mulligan mobilization with movement, the second one will receive instrument-assisted soft tissue mobilization and the third one will receive traditional therapy three times a week for four weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- mulligan mobilization and instrumented-assisted soft tissue mobilization
| Arm | Type | Receives |
|---|---|---|
| mulligan mobilization | Experimental | Other: mulligan mobilization, Other: conventional treatmentthe patients will receive mulligan mobilization three times a week for four weeks |
| instrumented assisted soft tissue mobilization | Experimental | Other: instrumented assisted soft tissue mobilization, Other: conventional treatmentthe patients will receive instrumented assisted soft tissue mobilization three times a week for four weeks |
| conventional treatment | Active comparator | Other: conventional treatmentthe patients will receive conventional treatment three times a week for four weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients will be diagnosed with chronic lateral epicondylitis from both genders.
- Patients with chronic lateral epicondylitis were diagnosed by orthopedists. Positive clinical manifestation in all patients. Patients' age will be ranged from 18 to 80 years, Pain onset is more than 3 months. All participants must be medically stable and not be treated with analgesics or any medication which may cause misleading results.
- All patients have a body mass index between 18.5 and 29.9 kg/m2.
Key exclusion criteria (3 listed)
- Patients who received an intra-articular injection for a duration of less than 3 months.
- Patients receiving oral or injected corticosteroids for the last 3 months at least.
- History of elbow surgery/fracture. Acute synovitis/arthritis including infectious. Presence of malignancy. Pregnancy. Patients with, topical lesions, contact dermatitis, and a history of cutaneous hypersensitivity
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 |
|---|---|---|
| mulligan mobilizationThe patients will receive mobilization with movement technique of lateral glide. the patients will be in supine subject and pronate forearm, during the application of the lateral glide by the physiotherapist, each patient was asked to perform the closure of the fist (provocative but painless gesture in the execution of the technique) for 3 sets of 10 repetitions. | Other | mulligan mobilization |
| instrumented assisted soft tissue mobilizationthe participant will receive instrumented assisted soft tissue mobilization. The participant's elbow will rest on a table. A lubricant (Vaseline) will be applied to the skin around the elbow prior to treatment and the blade will be cleaned with an alcohol pad. First, the blade will be used to find the exact areas of restriction in the common extensor origin. Then the M2T blade will be used in the treatment planes 1, 2, and 3, to apply slow strokes along the muscle, without causing any discomfort or pain, from the muscle origin to its insertion (sweeping technique) | Other | instrumented assisted soft tissue mobilization |
| conventional treatmentthe patients will receive conventional treatment in the form of Ultrasound therapy, conventional transcutaneous electrical nerve stimulation (TENS) - hot pack - stretching and strengthening exercises and wrist rest splints | Other | conventional treatment, instrumented assisted soft tissue mobilization, mulligan mobilization |
Primary outcome
pain intensity
Time frame: up to four weeks
pain will be measured by visual analogue scale. It is a vertical or horizontal 100 mm line graduated by different levels of pain, starting from 0 (no pain) till 100 (worst pain)
shoulder disability
Time frame: up to four weeks
The Arabic version of Disabilities of arm, shoulder, and hand (DASH) will be used for assessing shoulder function.DASH questionnaire includes 11 items with score from 0 to 100. A score of 0 represents no disability, while a score of 100 represents the most sever
2 secondary outcomes
range of motion
Time frame: up to four weeks
hand grip strength
Time frame: up to four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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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 mulligan mobilization, instrumented assisted soft tissue mobilization and conventional treatment in people with Lateral Epicondylitis, run by Cairo University.
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 3 inclusion and 3 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 22 Mar 2023. 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?
pain intensity (time frame: up to four 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 22 Mar 2023.