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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: standard treatment
standard treatment
Behavioral: mobilization
mobilization and exercise to be applied to patients with chronic lateral epicondylitis
Other Names:
  • excersize
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.
Other: standard treatment
standard treatment
Other: deep friction
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.
Other: standard treatment
standard treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Halic University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings