Epicondylitis of the ElbowNCT06440928
Results of Cervical Segmental Mobilization in Patients With Chronic Lateral Epicondylitis
A study testing mobilization, standard treatment and deep friction in people with Epicondylitis of the Elbow and Servical Segmental Mobilization, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 44 years
- Conditions the study is for
- Epicondylitis of the Elbow, Servical Segmental Mobilization
- What is being tested?
- mobilization, standard treatment and deep friction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
seda saka, asst.prof contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yalova University
Yalova
Mustafa Yığılıtaş, Doctorate, 05309782720
About this study
Official title: 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.
- Being tested
- mobilization, standard treatment, deep friction
- Keywords
- Lateral epicondylitis, Servical segmental mobilization, Pain, Quality of life, Grip strenght, Functionality
- Medical subject headings
- Tennis Elbow, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobilizationBehavioural
Also called excersize
mobilization and exercise to be applied to patients with chronic lateral epicondylitis
standard treatmentOther
standard treatment
deep frictionOther
deep friction
| Study group | Role | What they receive |
|---|---|---|
| intervention grup: standart treatment and segmental mobilization grup | Experimental | 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. Receives: Behavioral: mobilization; Other: standard treatment |
| intervention grup : standart treatment and deep friction | Experimental | 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. Receives: Other: standard treatment; Other: deep friction |
| intervention grup: standart treatment. | Experimental | 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. Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Pain
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.
Measured: 3 weeks
Quality of Life Short Form-36
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.
Measured: 3 weeks
Assessment of Functionality
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.
Measured: 3 weeks
Grip Strength
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start15 May 2024
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epicondylitis of the ElbowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised controlled and experimental study
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Yığılıtaş, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440928
- Sponsor's protocol ID
- 2023/106
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Cervical Segmental Mobilization on Pain, Functionality, Grip Strength and Quality of Life in Patients With Chronic Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT06440928
- Acronym / sponsor ID
- 2023/106
- Keywords
- Lateral epicondylitis, Servical segmental mobilization, Pain, Quality of life, Grip strenght, Functionality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomised controlled and experimental study
| Arm | Type | Receives |
|---|---|---|
| intervention grup: standart treatment and segmental mobilization grup | Experimental | Behavioral: mobilization, Other: standard treatmentMobilisation 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. |
| intervention grup : standart treatment and deep friction | Experimental | Other: standard treatment, Other: deep frictionThe 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. |
| intervention grup: standart treatment. | Experimental | Other: standard treatmentThe 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. |
Who may qualify
- Ages
- 25 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobilizationAlso: excersizemobilization and exercise to be applied to patients with chronic lateral epicondylitis | Behavioural | intervention grup: standart treatment and segmental mobilization grup |
| standard treatmentstandard treatment | Other | intervention grup : standart treatment and deep friction, intervention grup: standart treatment and segmental mobilization grup, intervention grup: standart treatment. |
| deep frictiondeep friction | Other | intervention grup : standart treatment and deep friction |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
seda saka, asst.prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobilization, standard treatment and deep friction in people with Epicondylitis of the Elbow and Servical Segmental Mobilization, run by Halic University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mustafa yığılıtaş, doctorate (05309782720, fztmy77@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Pain (time frame: 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.