NCT06440928

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

May 5, 2024

Last Update Submit

June 3, 2024

Conditions

Keywords

Lateral epicondylitisServical segmental mobilizationPainQuality of lifeGrip strenghtFunctionality

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    3 weeks

Study Arms (3)

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.

Behavioral: mobilizationOther: 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.

Other: standard treatmentOther: 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.

Other: standard treatment

Interventions

mobilizationBEHAVIORAL

mobilization and exercise to be applied to patients with chronic lateral epicondylitis

Also known as: excersize
intervention grup: standart treatment and segmental mobilization grup

standard treatment

intervention grup : standart treatment and deep frictionintervention grup: standart treatment and segmental mobilization grupintervention grup: standart treatment.

deep friction

intervention grup : standart treatment and deep friction

Eligibility Criteria

Age25 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yalova University

Yalova, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tennis ElbowPain

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

mustafa yığılıtaş, doctorate

CONTACT

seda saka, asst.prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomised controlled and experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

May 5, 2024

First Posted

June 4, 2024

Study Start

May 15, 2024

Primary Completion

August 15, 2024

Study Completion

October 15, 2024

Last Updated

June 4, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations