- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07187102
- Original Trial
Ultrasonographic Response to Cervical and Upper Thoracic SNAG in Medial Epicondylitis
Ultrasonographic Response to Cervical and Upper Thoracic SNAG in Treatment of Chronic Medial Epicondylitis, a Randomized Controlled Trial
Aim of the work :
- To detect if there is any change would occur in the neovascularity and echogenicity after using cervical and upper thoracic SNAG or not in ME patients.
- To find the effect of cervical and upper thoracic SNAG on pain, function of upper extremities, grip strength in ME comparing with traditional treatment alone
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Banī Suwayf, Egypt
- Faculty of Physical Therapy, Beni-Suef University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ranges from 35 to 50 years old in both sexes.
- Patients with LE that diagnosed by orthopedist.
- Pain onset is more than 3 months appear primarily with use or rest or in both, also , it appear with deep palpation of the medial epicondyle .
Exclusion Criteria:
• Rheumatoid Arthritis .
- Skin infection.
- History of previous elbow surgery.
- Any pathology in the shoulder joint.
- Neurologic deficit in upper extremity.
- Cervical disc prolapse and radiculopathy C5,6.
- Dislocation of elbow joint.
- Recent fractures of upper extremity.
- Arthrosis of the radiohumeral joint.
- Osteochondritis dissecans.
- Osteonecrosis.
- Plica synovialis.
- Participants receiving other treatment, in the form of physical therapy or medication, for the duration of the study that may interfere with the results of this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
|
A postero-anterior glide was applied to the spinous process of the C6-7 cervical. Ten repetitions were held for 10 seconds each, followed by a 30-second rest period. The patient sat comfortably with their back resting on a straight seat and their head and neck in a relaxed neutral position. After identifying the hypomobile segment, the clinician administered a single sub-therapeutic dose of thoracic SNAG at the specified treatment level. This technique involved performing one thoracic SNAG with a cephalad glide, applied parallel to the facet joint plane, aiming towards the patient's eyes. The clinician then positioned one arm around the patient's chest, just above the designated treatment level, ensuring that the ulnar border of the mobilizing hand was placed over the thoracic spinous process of the targeted level. Over four weeks, each patient had three therapy sessions per week, with a maximum of 12 sessions total. Conventional treatment, includes five sets of 30-second self-wrist flexor stretching; a total of 5 minutes of ultrasound therapy at a frequency of 3.3 MHz and a duty cycle of 1.2 W/cm²; five minutes of cross-friction massage focused on the most painful area; and fifteen minutes of heat application. Over four weeks, each patient had three therapy sessions per week, with a maximum of 12 sessions total. |
|
Other: control group
|
Conventional treatment, includes five sets of 30-second self-wrist flexor stretching; a total of 5 minutes of ultrasound therapy at a frequency of 3.3 MHz and a duty cycle of 1.2 W/cm²; five minutes of cross-friction massage focused on the most painful area; and fifteen minutes of heat application. Over four weeks, each patient had three therapy sessions per week, with a maximum of 12 sessions total. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Colour Ultrasonography
Time Frame: Baseline and after one month
|
Change in hypervascularity and hypoechogencity measured by colour sonography ( grade 1: grade 4) include: hypo-echoic variations within the common flexor tendon, tendon sheath thickening, ruptures of varying thickness, neovascularization as seen by Doppler, and cortical damage at the medial epicondyle
|
Baseline and after one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
Time Frame: Baseline and after one month
|
30-question outcome measure provided by patients to assess upper-limb function.
For those involved in sports and occupational assessments, an additional eight questions are available.
The questionnaire employs a Likert scale ranging from one to five (where one indicates no difficulty and five signifies incapacity).
The cumulative DASH rating runs between 0 and 100, with higher numbers reflecting bigger disability.
|
Baseline and after one month
|
|
A Patient-Rated Elbow Evaluation (PREE) questionnaire.
Time Frame: Baseline and after one month
|
A questionnaire consisting of 20 items designed to assess pain and impairment associated with elbow conditions.
It is divided into two main sections: function and pain.
The pain category contains 5 items, while the function category includes 15 aspects.
Within the functional section, there exist other subdivisions: Eleven items concentrate on specific activities, while four items relate to routine activities.
Every item is evaluated on a scale from 0 to 10.
The final ratingrelies on a 100-point scale, with impairment and pain weighted similarly.
Pain and disability increase with a higher PREE total score
|
Baseline and after one month
|
|
The hydraulic hand dynamometer.
Time Frame: Baseline and after one month
|
It is the most often utilized tool in research, has undergone extensive validation, and is the standard by which other tools are evaluated. Participants were positioned upright, either sitting with their knees and hips at a 90-degree angle and, if back support was available, in an elevated long-sitting position, or in bed. The dominant arm was positioned laterally, with the elbow extended at 90° and unsupported, while the wrist remained in neutral posture. Individuals were advised to use their main hand to force the dynamometer as strong as possible. For each device, three trials were recorded, and the one with the greatest score was maintained for review. Following the initial set of measurements, the volunteers took a 30-minute break before repeating the process with the second device. |
Baseline and after one month
|
|
Visual analog scale
Time Frame: Baseline and after one month
|
Pain intensity for the elbow was measured using a ten-centimeter straight visual analogue scale (VAS), with 0 reflecting painlessness and 10 meaning the highest discomfort ever experienced.
|
Baseline and after one month
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMBSUREC/07092025/Ahmed
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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