- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06440928
Results of Cervical Segmental Mobilization in Patients With Chronic Lateral Epicondylitis
June 3, 2024 updated by: Mustafa Yığılıtaş, Halic University
Investigation of the Effect of Cervical Segmental Mobilization on Pain, Functionality, Grip Strength and Quality of Life in Patients With Chronic Lateral Epicondylitis
The aim of our study was to investigate the effect of cervical segmental mobilization on pain, functionality, grip strength and quality of life in patients with chronic lateral epicondylitis.
It was planned as a randomized controlled experimental study.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: mustafa yığılıtaş, doctorate
- Phone Number: 05309782720
- Email: fztmy77@hotmail.com
Study Contact Backup
- Name: seda saka, asst.prof
- Email: seda.saka@halic.edu.tr
Study Locations
-
-
-
Yalova, Turkey
- Recruiting
- Yalova University
-
Contact:
- Mustafa Yığılıtaş, Doctorate
- Phone Number: 05309782720
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being between the ages of 25-44
- Being diagnosed with LE by a physician
- Not having any defined pathology in the cervical region
- No neurological problems in the upper extremities
- No history of cervical surgery
Exclusion Criteria:
- Those with a history of infection, tumor, trauma in the cervical area
- Fibromyalgia patients
- Congenital or acquired deformities of the upper extremity
- History of shoulder or elbow surgery or dislocation
- Cervical radiculopathy
- Having had Wiplash
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention grup: standart treatment and segmental mobilization grup
Mobilisation specifically on the C7 segment will be performed by the physiotherapist 2 times a week for 3 weeks, making decisions on the choice of key parameters including treatment technique, spinal level, degree, direction, side and duration.
|
standard treatment
mobilization and exercise to be applied to patients with chronic lateral epicondylitis
Other Names:
|
|
Experimental: intervention grup : standart treatment and deep friction
The patients were asked to stretch for 20 s with the other hand with the shoulder in internal rotation, elbow in extension, forearm in pronation, wrist in flexion and ulnar deviation.
In the first week, stretching exercises were recommended to be performed 3 sets a day, 5⨯20 s in one set and 45 s rest interval before strengthening exercises.
The application will be performed with the thumb in the transverse direction, with the pressure tolerated by the individual, for 10 minutes after numbness is obtained, the treatment lasts approximately 10-15 minutes.
|
standard treatment
deep friction
|
|
Experimental: intervention grup: standart treatment.
The patients were asked to stretch for 20 s with the other hand with the shoulder in internal rotation, elbow in extension, forearm in pronation, wrist in flexion and ulnar deviation.
In the first week, stretching exercises were recommended to be performed 3 sets a day, 5⨯20 s in one set and 45 s rest interval before strengthening exercises.
Starting from the 2nd week of treatment, it will be requested to be performed 3 sets a day, 5⨯20 s in one set, 5⨯20 s before exercise and 5⨯20 s after exercise.
|
standard treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of Pain
Time Frame: 3 weeks
|
In the assessment of pain, the "Visuel Analog Scale (VAS)" will be used and people will be asked to indicate the severity of their pain in the last 24 hours on a 10 cm chart.
Before and after the session, VAS will be evaluated and recorded with the values measured with algometer.
According to the pain scale in VAS application; "0" means no pain and "10" means the presence of unbearable pain, while patients will be asked to mark the pain they feel numerically between 0-10.
|
3 weeks
|
|
Quality of Life Short Form-36
Time Frame: 3 weeks
|
The scale consists of 36 statements.
The scale has 8 dimensions including physical functioning (FF), social functioning (SF), role limitations related to physical functioning (RRF), role limitations related to emotional problems (ERR), mental health (MS), vitality (C), bodily pain (BA) and general health perception (GS).
Quality of life increases as the scores on the scale increase.
Minimum score is 0 and maximum score is 100.
|
3 weeks
|
|
Assessment of Functionality
Time Frame: 3 weeks
|
Duruöz Hand Index (DEI) specifically for rheumatoid arthritis patients.
The index includes hand dexterity in the kitchen, during dressing, while maintaining personal hygiene, at work and other general movements.
Participants rate 18 items from 0 (no difficulty) to 5 (impossible to do).
The total score ranges from 0-90.
A high score indicates impaired hand function.
|
3 weeks
|
|
Grip Strength
Time Frame: 3 weeks
|
Grip strength will be evaluated with Jamar Hand Dynamometer.
In the grip strength evaluations of the hand, measurements will be taken from both the patient and the healthy side.
In the measurements made from the patient side, painless grip strength and maximum grip strength will be evaluated separately in the elbow flexion position and elbow extension position.
On the healthy side, maximum grip strength will be evaluated in both positions.
Patients will be positioned and evaluated according to the holding and gripping force of the dynamometer to be used.
The patient will be asked to squeeze the dynamometer as strongly as possible for 5 seconds, first with the intact and then with the affected side, and 3 measurements will be made with one-minute breaks between the measurements and the averages will be recorded.
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2024
Primary Completion (Estimated)
August 15, 2024
Study Completion (Estimated)
October 15, 2024
Study Registration Dates
First Submitted
May 5, 2024
First Submitted That Met QC Criteria
June 3, 2024
First Posted (Actual)
June 4, 2024
Study Record Updates
Last Update Posted (Actual)
June 4, 2024
Last Update Submitted That Met QC Criteria
June 3, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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