Lateral EpicondylitisNCT05447468
Influence of Proximal Motor Control in Treating Lateral Epicondylitis
A study testing Strength of lower trapezius, Strength of middle trapezius and Strength of serratus anterior in people with Lateral Epicondylitis, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the effect of scapular muscles (lower trapezius, middle trapezius and serratus anterior) strengthening on pain, pain free hand grip strength and functional outcome added to conventional physical therapy in patients with chronic Lateral Epicondylitis. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Strength of lower trapezius, Strength of middle trapezius and Strength of serratus anterior
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2022to 1 Nov 2022
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Symptoms of lateral epicondylitis from at least the past 3 months.
- Pain in at least two of the following four tests; Tomsen test, Maudsley test, Mill's test and handgrip dynamometer test.
- Their ages range from 30-50 years old.
Who cannot join
- Subjects will be excluded from the study if they have:
- Peripheral neuropathy.
- Lesions of upper limb nerves.
- History of surgery in the affected elbow 6 months ago.
- Cervical radiculopathy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic, Faculty of Physical Therapy, Cairo university
Dokki, 34518
About this study
This study will be conducted to investigate the effect of scapular muscles (lower trapezius, middle trapezius and serratus anterior) strengthening on pain, pain free hand grip strength and functional outcome added to conventional physical therapy in patients with chronic Lateral Epicondylitis.
Read the detailed description
This study will try to investigate if scapular muscles strengthening have an effective role on pain, pain free hand grip strength and function when added to conventional physical therapy in patients with LE.
- Conditions
- Lateral Epicondylitis
- Being tested
- Strength of lower trapezius, Strength of middle trapezius, Strength of serratus anterior, Pulsed ultrasound, Stretching of extensor carpi radialis brevis muscle
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength of lower trapeziusOther
Ask the patient to raise arm above the head with upper extremity in line with lower trapezius muscle fibers in prone position with the shoulder joint at 135 degrees. The patient will be asked to hold position 6 seconds and perform 3 sets of 10 repetitions and 3times per week for 6 weeks.
Strength of middle trapeziusOther
Shoulder external rotation with the shoulder abducted 90ₒ and elbow flexed 90ₒ in prone position with elbow supported on the table. The patient will be asked to hold position 6 seconds and perform 3 sets of 10 repetitions and 3times per week for 6 weeks.
Strength of serratus anteriorOther
Ask the patient to raise the arm on a wall in the plane of the scapula in standing position.
The patient will be asked to hold position 6 seconds and perform 3 sets of 10 repetitions and 3times per week for 6 weeks.
Pulsed ultrasoundOther
With a 20% duty cycle, frequency of 1 MHz and intensity of 1.5 w/cm² for 5 minutes 3 times per week for 6 weeks.
Stretching of extensor carpi radialis brevis muscleOther
Put the elbow in extension, forearm in pronation and wrist in flexion with ulnar deviation. Hold for 30s and repeat 3 times with 30s rest in between. Three times per week for 6 weeks.
Eccentric exercises of wrist extensorsOther
Ask the patient to extend elbow, pronate forearm, extend wrist and then flex the wrist slowly until full flexion is achieved. Patients should apply 3 sets of 10 repetitions 3 times per week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| scapular muscles strengthning group | Experimental | Patients in this group A will receive scapular muscles (lower trapezius, middle trapezius and serratus anterior) strengthening along with conventional physiotherapy (pulsed ultrasound, static stretching of ECRB muscle and eccentric exercises of wrist extensors) for 6 weeks. Receives: Other: Strength of lower trapezius; Other: Strength of middle trapezius; Other: Strength of serratus anterior; Other: Pulsed ultrasound; Other: Stretching of extensor carpi radialis brevis muscle; Other: Eccentric exercises of wrist extensors |
| conventional physiotherapy group | Active comparator | Patients in this group B will receive conventional physiotherapy only (pulsed ultrasound, static stretching of ECRB muscle and eccentric exercises of wrist extensors) 3 sessions per week for 6 weeks. Receives: Other: Pulsed ultrasound; Other: Stretching of extensor carpi radialis brevis muscle; Other: Eccentric exercises of wrist extensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change in pain intensity
Using Visual analouge scale (VAS), a continuous 10 cm line ranges from no pain to very severe pain which is valid and reliable tool. The patient marks on the line the point that they feel represents their pain intensity.
Measured: at baseline and after 6 weeks of intervention
Assessment of change in hand grip strength
Patient stands with the elbow in complete extension and the shoulder and radioulnar joints in neutral rotation. Ask the patient to slowly squeeze the dynamometer and to stop the instant discomfort is first felt. It will be performed three repetitions separated by a 20-second rest interval. Average of three trials will be recorded. The measurement is valid and reliable.
Measured: at baseline and after 6 weeks of intervention
Assessment of change in function
Using PRTEEQ. It is a 15-item self-reported questionnaire to measure perceived pain and disability in people with LE. It has three subscales: pain, usual activities and specific activities. Each of the items of the Patient rated tennis elbow evaluation questionnaire (PRTEEQ) is scored on a 0-10 scale, where 0 is 'no pain' or 'no difficulty' and10 is 'worst ever' or 'unable to do. Ask the patients to rate the pain and difficulty that they have experienced in the last week by marking the suitable response that reflects their current state. The total score ranges from 0 to 100, where high scores indicate greater pain and disability.
Measured: at baseline and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start15 Jul 2022 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion1 Nov 2022 (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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Mohamed, Cairo University
- Investigators
- Shereen Mohamed, physiotherapist, Principal investigator, shereenm34@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447468
- Sponsor's protocol ID
- P.T.REC/012/003304
- Status last verified
- Jul 2022
- First submitted
- 1 Jul 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Proximal Motor Control in Treating Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT05447468
- Acronym / sponsor ID
- P.T.REC/012/003304
- Conditions
- Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 7 Jul 2022 (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 investigate the effect of scapular muscles (lower trapezius, middle trapezius and serratus anterior) strengthening on pain, pain free hand grip strength and functional outcome added to conventional physical therapy in patients with chronic Lateral Epicondylitis.
Detailed description
This study will try to investigate if scapular muscles strengthening have an effective role on pain, pain free hand grip strength and function when added to conventional physical therapy in patients with LE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scapular muscles strengthning group | Experimental | Other: Strength of lower trapezius, Other: Strength of middle trapezius, Other: Strength of serratus anterior, Other: Pulsed ultrasound, Other: Stretching of extensor carpi radialis brevis muscle, Other: Eccentric exercises of wrist extensorsPatients in this group A will receive scapular muscles (lower trapezius, middle trapezius and serratus anterior) strengthening along with conventional physiotherapy (pulsed ultrasound, static stretching of ECRB muscle and eccentric exercises of wrist extensors) for 6 weeks. |
| conventional physiotherapy group | Active comparator | Other: Pulsed ultrasound, Other: Stretching of extensor carpi radialis brevis muscle, Other: Eccentric exercises of wrist extensorsPatients in this group B will receive conventional physiotherapy only (pulsed ultrasound, static stretching of ECRB muscle and eccentric exercises of wrist extensors) 3 sessions per week for 6 weeks. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Symptoms of lateral epicondylitis from at least the past 3 months.
- Pain in at least two of the following four tests; Tomsen test, Maudsley test, Mill's test and handgrip dynamometer test.
- Their ages range from 30-50 years old.
Key exclusion criteria (5 listed)
- Peripheral neuropathy.
- Lesions of upper limb nerves.
- History of surgery in the affected elbow 6 months ago.
- Cervical radiculopathy.
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 |
|---|---|---|
| Strength of lower trapeziusAsk the patient to raise arm above the head with upper extremity in line with lower trapezius muscle fibers in prone position with the shoulder joint at 135 degrees. The patient will be asked to hold position 6 seconds and perform 3 sets of 10 repetitions and 3times per week for 6 weeks. | Other | scapular muscles strengthning group |
| Strength of middle trapeziusShoulder external rotation with the shoulder abducted 90ₒ and elbow flexed 90ₒ in prone position with elbow supported on the table. The patient will be asked to hold position 6 seconds and perform 3 sets of 10 repetitions and 3times per week for 6 weeks. | Other | scapular muscles strengthning group |
| Strength of serratus anteriorAsk the patient to raise the arm on a wall in the plane of the scapula in standing position. The patient will be asked to hold position 6 seconds and perform 3 sets of 10 repetitions and 3times per week for 6 weeks. | Other | scapular muscles strengthning group |
| Pulsed ultrasoundWith a 20% duty cycle, frequency of 1 MHz and intensity of 1.5 w/cm² for 5 minutes 3 times per week for 6 weeks. | Other | conventional physiotherapy group, scapular muscles strengthning group |
| Stretching of extensor carpi radialis brevis musclePut the elbow in extension, forearm in pronation and wrist in flexion with ulnar deviation. Hold for 30s and repeat 3 times with 30s rest in between. Three times per week for 6 weeks. | Other | conventional physiotherapy group, scapular muscles strengthning group |
| Eccentric exercises of wrist extensorsAsk the patient to extend elbow, pronate forearm, extend wrist and then flex the wrist slowly until full flexion is achieved. Patients should apply 3 sets of 10 repetitions 3 times per week for 6 weeks. | Other | conventional physiotherapy group, scapular muscles strengthning group |
Primary outcome
Assessment of change in pain intensity
Time frame: at baseline and after 6 weeks of intervention
Using Visual analouge scale (VAS), a continuous 10 cm line ranges from no pain to very severe pain which is valid and reliable tool. The patient marks on the line the point that they feel represents their pain intensity.
Assessment of change in hand grip strength
Time frame: at baseline and after 6 weeks of intervention
Patient stands with the elbow in complete extension and the shoulder and radioulnar joints in neutral rotation. Ask the patient to slowly squeeze the dynamometer and to stop the instant discomfort is first felt. It will be performed three repetitions separated by a 20-second rest interval. Average of three trials will be recorded. The measurement is valid and reliable.
Assessment of change in function
Time frame: at baseline and after 6 weeks of intervention
Using PRTEEQ. It is a 15-item self-reported questionnaire to measure perceived pain and disability in people with LE. It has three subscales: pain, usual activities and specific activities. Each of the items of the Patient rated tennis elbow evaluation questionnaire (PRTEEQ) is scored on a 0-10 scale, where 0 is 'no pain' or 'no difficulty' and10 is 'worst ever' or 'unable to do. Ask the patients to rate the pain and difficulty that they have experienced in the last week by marking the suitable response that reflects their current state. The total score ranges from 0 to 100, where high scores indicate greater pain and disability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
Shereen Mohamed, physiotherapist principal investigator
shereenm34@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength of lower trapezius, Strength of middle trapezius and Strength of serratus anterior in people with Lateral Epicondylitis, run by Cairo University at 1 site in Egypt.
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 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 7 Jul 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shereen Mohamed, physiotherapist (+201153470826, shereenm34@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of change in pain intensity (time frame: at baseline and after 6 weeks of intervention). 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?
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 7 Jul 2022.