NCT05447468

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

July 1, 2022

Last Update Submit

July 1, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    at baseline and after 6 weeks of intervention

Study Arms (2)

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.

Other: Strength of lower trapeziusOther: Strength of middle trapeziusOther: Strength of serratus anteriorOther: Pulsed ultrasoundOther: Stretching of extensor carpi radialis brevis muscleOther: 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.

Other: Pulsed ultrasoundOther: Stretching of extensor carpi radialis brevis muscleOther: Eccentric exercises of wrist extensors

Interventions

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.

scapular muscles strengthning group

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.

scapular muscles strengthning group

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.

scapular muscles strengthning group

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.

conventional physiotherapy groupscapular muscles strengthning group

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.

conventional physiotherapy groupscapular muscles strengthning group

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.

conventional physiotherapy groupscapular muscles strengthning group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic, Faculty of Physical Therapy, Cairo university

Dokki, 34518, Egypt

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Ultrasonic Waves

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

SoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Shereen Mohamed, physiotherapist

    shereenm34@gmail.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shereen Mohamed, physiotherapist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 7, 2022

Study Start

July 15, 2022

Primary Completion

October 15, 2022

Study Completion

November 1, 2022

Last Updated

July 7, 2022

Record last verified: 2022-07

Locations