NCT05947968

Brief 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.

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 Nov 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

July 9, 2023

Last Update Submit

July 9, 2023

Conditions

Keywords

scapular PNFscapular proprioceptive neuromuscular facilitation exerciseshoulder strengthening exercises

Outcome Measures

Primary Outcomes (3)

  • 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.

    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: 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

    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.

    one month

Study Arms (2)

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.

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)

Other: Shoulder strengthening exercises

Interventions

Scapular 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.

Group A (Scapular PNF)

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. 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).

Group B (Shoulder exercises)

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Central Study Contacts

Mahmoud Ghallab, Master

CONTACT

Mohamed Ahmed, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

July 9, 2023

First Posted

July 17, 2023

Study Start

November 15, 2022

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

July 17, 2023

Record last verified: 2023-07

Locations