Back to resultsInfluence of Proximal Motor Control in Treating Lateral Epicondylitis
Primary Purpose
Lateral Epicondylitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Strength of lower trapezius
Strength of middle trapezius
Strength of serratus anterior
Pulsed ultrasound
Stretching of extensor carpi radialis brevis muscle
Eccentric exercises of wrist extensors
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Sites / Locations
- Outpatient clinic, Faculty of Physical Therapy, Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
scapular muscles strengthning group
conventional physiotherapy group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05447468
Brief Title
Influence of Proximal Motor Control in Treating Lateral Epicondylitis
Official Title
Influence of Proximal Motor Control in Treating Lateral Epicondylitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 15, 2022 (Anticipated)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
scapular muscles strengthning group
Arm Type
Experimental
Arm Description
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.
Arm Title
conventional physiotherapy group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Strength of lower trapezius
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Strength of middle trapezius
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Strength of serratus anterior
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pulsed ultrasound
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stretching of extensor carpi radialis brevis muscle
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Eccentric exercises of wrist extensors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of change in pain intensity
Description
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.
Time Frame
at baseline and after 6 weeks of intervention
Title
Assessment of change in hand grip strength
Description
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.
Time Frame
at baseline and after 6 weeks of intervention
Title
Assessment of change in function
Description
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.
Time Frame
at baseline and after 6 weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shereen Mohamed, physiotherapist
Phone
+201153470826
Email
shereenm34@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shereen Mohamed, physiotherapist
Organizational Affiliation
shereenm34@gmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic, Faculty of Physical Therapy, Cairo university
City
Dokki
ZIP/Postal Code
34518
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Influence of Proximal Motor Control in Treating Lateral Epicondylitis
We'll reach out to this number within 24 hrs