Lateral EpicondylitisPNFNCT05947968
Scapular PNF Versus Shoulder Strengthening Exercises in Patients With Lateral Epicondylitis.
A study testing Scapular PNF and Shoulder strengthening exercises in people with Lateral Epicondylitis, run by Mahmoud Essam Abu Elfetouh Ghallab at 1 site in Egypt.
Trial summary
The purpose of this study is to compare between the effect of scapular proprioceptive neuromuscular facilitation versus shoulder and scapular strengthening exercise on pain, functional outcome and grip strength in patients with lateral epicondylitis. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Scapular PNF and Shoulder strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2022to Oct 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients will be included if they have the following criteria:
- Fifty-two male and female subjects.
- Patients complaining of chronic lateral epicondylitis (more than three months).
- Age between 20-50.
Who cannot join
- Patients will be excluded if they had any of the following conditions:
- Received physiotherapy in last 3 months.
- Received corticosteroids injection in lateral epicondyle in last 3 months.
- Receiving anti-inflammatories medications on regular basis.
- Had neurologic problems in shoulder, neck and thoracic regions.
- Had history of rheumatic disease.
- Had cooperation difficulties due to cognitive disorders. All Patients will be instructed to keep away from activities that aggravate the symptoms such as grasping, lifting, knitting and using a screwdriver during the treatment period.
Trial locations and contacts
1 site in 1 country.
Mohamed Ahmed, Lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza
Mahmoud Ghallab, Master, 00201001899452, mahmoudasam93@hotmail.com
Mohamed Ahmed, Lecturer, 00201223631604
About this study
Official title: Scapular Proprioception Neuromuscular Facilitation Versus Shoulder Strengthening Exercises in Patients With Lateral Epicondylitis.
The purpose of this study is to compare between the effect of scapular proprioceptive neuromuscular facilitation versus shoulder and scapular strengthening exercise on pain, functional outcome and grip strength in patients with lateral epicondylitis.
Read the detailed description
There is no standard treatment for lateral epicondylitis, it is always a combination of physical therapy modalities aimed to reduce pain and increase the ability to return functional activities participation. Accordingly, many researchers have added shoulder strengthening exercise to the rehabilitation plan for treating lateral epicondylitis.
Consequently, development of new concept of scapula motor control exercise using proprioceptive neuromuscular facilitation to add proximal stability to patients with lateral epicondylitis may be beneficial. We believe that this study can serve as a step toward documenting the evidence of scapular proprioceptive neuromuscular facilitation exercise in the treatment of patients with lateral epicondylitis which was not available before.
Patients with lateral epicondylitis will be recruited after approval of ethical committee of the faculty of physical therapy, Cairo University. All participants will sign a written informed consent form. After group assignment, patients' demographics will be collected, and then assessment of pain, function and grip strength will be performed. The same assessment procedure will be conducted by the end of the treatment (by the end of the 12th visit).
The study will be two comparative groups, pre-post experimental design, the subjects will be randomly assigned into one of two groups:
- Group (I) : will receive scapular proprioceptive neuromuscular facilitation exercises.
- Group (II) : will receive shoulder strengthening exercises.
- Conditions
- Lateral Epicondylitis
- Being tested
- Scapular PNF, Shoulder strengthening exercises
- Keywords
- scapular PNF, scapular proprioceptive neuromuscular facilitation exercise, shoulder strengthening exercises
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapular PNFOther
Scapular proprioceptive neuromuscular facilitation exercise: will be applied in two diagonals:
- anterior elevation and posterior depression
- posterior elevation and anterior depression for 3 sets of 10 repetitions, The rest interval between sets will be 20 seconds.
Patients will lay on the unaffected side while the therapist stands in the line of desired motion. Firstly, the therapist will give preparatory instructions. In the beginning of the pattern, the therapist pulls the scapula to the elongated position and then gives instructions for the desired movement.
Shoulder strengthening exercisesOther
Shoulder strengthening exercises:
The following four exercises will focus on shoulder and scapular strengthening. Before starting the program, the patients will be thoroughly instructed in the four exercises, and illustrations with specific exercise instructions will be provided. All subjects will perform the exercises with the affected side for three sets of 10 repetitions for each exercise, with a 1-minute rest between sets.
- Standing shoulder external rotation with elastic resistance.
- Bilateral external rotation with scapular retraction exercise.
- Resisted scapular retraction with shoulder external rotation (Middle trapezius muscle).
- Weighted scapular retraction and downward rotation Y-shape (lower trapezius muscle).
| Study group | Role | What they receive |
|---|---|---|
| Group A (Scapular PNF) | Experimental | will receive scapular proprioceptive neuromuscular facilitation exercise plus conventional treatment of lateral epicondylitis for 12 sessions (3 sessions per week for four weeks).
The conventional treatment of lateral epicondylitis will be:
1. Pulsed ultrasound over the lateral epicondyle for 5 min.
2. Five minutes of deep friction massage. It will be consisted of deep circular motions using the fingertips over the area of maximal tenderness at the lateral epicondyle.
3. Stretching exercise for extensor carpi radialis longus and brevis for 3 repetitions, each repetition will be 45 seconds with 30 seconds' rest.
4. Strengthening exercise for wrist extensors, eccentric exercise for wrist extensors will be as follow: 3 sets, 10 repetitions, 1 min rest interval between each set. Receives: Other: Scapular PNF |
| Group B (Shoulder exercises) | Experimental | will receive shoulder strengthening exercise plus conventional treatment of lateral epicondylitis for 12 sessions (3 sessions per week for four weeks).
Same conventional treatment in group (A) Receives: Other: Shoulder strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity by The Numeric Pain Rating Scale (NPRS)
(NPRS) is a unidimensional measure of pain intensity in adults. Consists of 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g., "no pain") to '10' representing the other pain extreme (e.g., "pain as bad as you can imagine" or "worst pain imaginable.
Measured: one month
Pain and functional disability by patient-rated tennis elbow evaluation (PRTEE)
The PRTEE is a valid and reliable tool that may be used in both research and clinical settings to assess the subjective outcome in patient with lateral epicondylitis. Subjects will be asked to rate the level of discomfort and difficulty they had encountered in the previous week. High total scores imply more pain and impairment; the scale spans from 0 to 100.
The PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with LE. The PRTEE allows patients to rate their levels of pain and disability from 0 to 10, and consists of 2 subscales:
- PAIN subscale (0 = no pain, 10 = worst imaginable)
- Pain - 5 items
- FUNCTION subscale (0 = no difficulty, 10 = unable to do)
- Specific activities - 6 items
- Usual activities - 4 items
Measured: one month
Grip strength by Jammar handheld dynamometer.
The Jammar hand grip dynamometer is valid and reliable, will be used to assess the subject's pain-free grip strength while they are lying on their side with their elbow extended and pronated. Subjects will be instructed to squeeze the dynamometer handles until they experienced pain. It will be performed three times with 20 s rest period between repetitions. Average of three trials will be recorded in kilograms.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start15 Nov 2022
- Primary completionSep 2023 (estimated)
- Study completionOct 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.
- 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
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Essam Abu Elfetouh Ghallab
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Mahmoud Essam Abu Elfetouh Ghallab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947968
- Sponsor's protocol ID
- Lateral epicondylitis
- Acronym
- PNF
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scapular Proprioception Neuromuscular Facilitation Versus Shoulder Strengthening Exercises in Patients With Lateral Epicondylitis.
- ClinicalTrials.gov ID
- NCT05947968
- Acronym / sponsor ID
- PNF / Lateral epicondylitis
- Conditions
- Lateral Epicondylitis
- Keywords
- scapular PNF, scapular proprioceptive neuromuscular facilitation exercise, shoulder strengthening exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Mahmoud Essam Abu Elfetouh GhallabUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 17 Jul 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.
The purpose of this study is to compare between the effect of scapular proprioceptive neuromuscular facilitation versus shoulder and scapular strengthening exercise on pain, functional outcome and grip strength in patients with lateral epicondylitis.
Detailed description
There is no standard treatment for lateral epicondylitis, it is always a combination of physical therapy modalities aimed to reduce pain and increase the ability to return functional activities participation. Accordingly, many researchers have added shoulder strengthening exercise to the rehabilitation plan for treating lateral epicondylitis.
Consequently, development of new concept of scapula motor control exercise using proprioceptive neuromuscular facilitation to add proximal stability to patients with lateral epicondylitis may be beneficial. We believe that this study can serve as a step toward documenting the evidence of scapular proprioceptive neuromuscular facilitation exercise in the treatment of patients with lateral epicondylitis which was not available before.
Patients with lateral epicondylitis will be recruited after approval of ethical committee of the faculty of physical therapy, Cairo University. All participants will sign a written informed consent form. After group assignment, patients' demographics will be collected, and then assessment of pain, function and grip strength will be performed. The same assessment procedure will be conducted by the end of the treatment (by the end of the 12th visit).
The study will be two comparative groups, pre-post experimental design, the subjects will be randomly assigned into one of two groups:
- Group (I) : will receive scapular proprioceptive neuromuscular facilitation exercises.
- Group (II) : will receive shoulder strengthening exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Scapular PNF) | Experimental | Other: Scapular PNFwill receive scapular proprioceptive neuromuscular facilitation exercise plus conventional treatment of lateral epicondylitis for 12 sessions (3 sessions per week for four weeks). The conventional treatment of lateral epicondylitis will be: 1. Pulsed ultrasound over the lateral epicondyle for 5 min. 2. Five minutes of deep friction massage. It will be consisted of deep circular motions using the fingertips over the area of maximal tenderness at the lateral epicondyle. 3. Stretching exercise for extensor carpi radialis longus and brevis for 3 repetitions, each repetition will be 45 seconds with 30 seconds' rest. 4. Strengthening exercise for wrist extensors, eccentric exercise for wrist extensors will be as follow: 3 sets, 10 repetitions, 1 min rest interval between each set. |
| Group B (Shoulder exercises) | Experimental | Other: Shoulder strengthening exerciseswill receive shoulder strengthening exercise plus conventional treatment of lateral epicondylitis for 12 sessions (3 sessions per week for four weeks). Same conventional treatment in group (A) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients will be included if they have the following criteria:
Key exclusion criteria (7 listed)
- Patients will be excluded if they had any of the following conditions:
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 |
|---|---|---|
| Scapular PNFScapular proprioceptive neuromuscular facilitation exercise: will be applied in two diagonals: 1. anterior elevation and posterior depression 2. posterior elevation and anterior depression for 3 sets of 10 repetitions, The rest interval between sets will be 20 seconds. Patients will lay on the unaffected side while the therapist stands in the line of desired motion. Firstly, the therapist will give preparatory instructions. In the beginning of the pattern, the therapist pulls the scapula to the elongated position and then gives instructions for the desired movement. | Other | Group A (Scapular PNF) |
| Shoulder strengthening exercisesShoulder strengthening exercises: The following four exercises will focus on shoulder and scapular strengthening. Before starting the program, the patients will be thoroughly instructed in the four exercises, and illustrations with specific exercise instructions will be provided. All subjects will perform the exercises with the affected side for three sets of 10 repetitions for each exercise, with a 1-minute rest between sets. 1. Standing shoulder external rotation with elastic resistance. 2. Bilateral external rotation with scapular retraction exercise. 3. Resisted scapular retraction with shoulder external rotation (Middle trapezius muscle). 4. Weighted scapular retraction and downward rotation Y-shape (lower trapezius muscle). | Other | Group B (Shoulder exercises) |
Primary outcome
Pain intensity by The Numeric Pain Rating Scale (NPRS)
Time frame: one month
(NPRS) is a unidimensional measure of pain intensity in adults. Consists of 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g., "no pain") to '10' representing the other pain extreme (e.g., "pain as bad as you can imagine" or "worst pain imaginable.
Pain and functional disability by patient-rated tennis elbow evaluation (PRTEE)
Time frame: one month
The PRTEE is a valid and reliable tool that may be used in both research and clinical settings to assess the subjective outcome in patient with lateral epicondylitis. Subjects will be asked to rate the level of discomfort and difficulty they had encountered in the previous week. High total scores imply more pain and impairment; the scale spans from 0 to 100. The PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with LE. The PRTEE allows patients to rate their levels of pain and disability from 0 to 10, and consists of 2 subscales: 1. PAIN subscale (0 = no pain, 10 = worst imaginable) • Pain - 5 items 2. FUNCTION subscale (0 = no difficulty, 10 = unable to do) * Specific activities - 6 items * Usual activities - 4 items
Grip strength by Jammar handheld dynamometer.
Time frame: one month
The Jammar hand grip dynamometer is valid and reliable, will be used to assess the subject's pain-free grip strength while they are lying on their side with their elbow extended and pronated. Subjects will be instructed to squeeze the dynamometer handles until they experienced pain. It will be performed three times with 20 s rest period between repetitions. Average of three trials will be recorded in kilograms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- 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.
Mohamed Ahmed, Lecturer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scapular PNF and Shoulder strengthening exercises in people with Lateral Epicondylitis, run by Mahmoud Essam Abu Elfetouh Ghallab 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 4 inclusion and 7 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 17 Jul 2023. 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 Mahmoud Ghallab, Master (00201001899452, mahmoudasam93@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity by The Numeric Pain Rating Scale (NPRS) (time frame: one month). 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 17 Jul 2023.