NCT05504759

Brief Summary

In this study, investigators aimed to investigate the effects of rest, steroid injection and dry needling treatments, which are frequently used in the treatment of patients diagnosed with lateral epicondylitis (tennis elbow), on the pain and functional status of the patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 2, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2023

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

March 31, 2022

Last Update Submit

August 15, 2022

Conditions

Keywords

tennis elbowdry needling

Outcome Measures

Primary Outcomes (1)

  • change in elbow pain after treatment as assessed by vas

    Elbow pain will be measured with the Visual Analog Scale (VAS).The Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line, and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing. For example, for pain, I have no pain at one end and very severe pain at the other end and the patient marks his/her current state on this line. The length of the distance from the point where there is no pain to the point marked by the patient indicates the patient's pain.

    before treatment, second-month control after treatment

Secondary Outcomes (1)

  • Hand grip strength

    before treatment, second-month control after treatment.

Study Arms (3)

Group 1

EXPERIMENTAL

2 weeks rest protocol + standardized exercise program

Other: splint

Group 2

EXPERIMENTAL

local steroid injection + 2 weeks rest protocol + standardized exercise program

Other: splintOther: steroid

Group 3

EXPERIMENTAL

dry needling of forearm extensor muscles + 2 weeks rest protocol + standardized exercise program

Other: splintOther: dry needling

Interventions

splintOTHER

Resting is the first step of treatment in lateral epicondylitis. Patients will be given a 2 weeks rest protocol (works that may cause strain on the wrist and increase elbow pain will be described and it will be advised to stay away, and a home exercise program will be prepared, which includes the use of a resting splint during the daytime for 2 weeks). The goal of exercise therapy will be to stretch the muscles, strengthen them and maintain flexibility. Home exercises during the treatment of lateral epicondylitis will be beneficial when performed twice a day for at least three months, and stretching exercises will be performed first, and then strengthening exercises will be started in a controlled manner.

Group 1Group 2Group 3
steroidOTHER

Betamethasone Dipropionate + Betamethasone Sodium Phosphate-1 ml will be administered once at the beginning of the study to patients who will receive steroid injection, one of the local injection treatments. Steroid injection will be applied to the most sensitive point on the lateral epicondyle. Afterwards, patients will be given a 2 weeks rest protocol (works that may cause strain on the wrist and increase elbow pain will be described and it will be advised to stay away, and a home exercise program will be prepared, which includes the use of a resting splint during daytime hours for 2 weeks). The goal of exercise therapy will be to stretch the muscles, strengthen them and maintain flexibility. Home exercises during the treatment of lateral epicondylitis will be beneficial when performed twice a day for at least three months, and stretching exercises will be performed first, and then strengthening exercises will be started in a controlled manner.

Group 2

The needle will be guided to painful trigger points detected by palpation. Stainless steel 25x30 mm needles will be used for dry needling. Dry needle treatment will be applied to the painful trigger points in the forearm extensor group muscles with the stick-pull technique, 1 session per week, for a total of 2 sessions. Afterwards, the patients will be given a 2 weeks rest protocol (works that may strain the wrist and increase elbow pain will be described and it will be advised to stay away, and a home exercise program will be prepared, which includes the use of a resting splint during the daytime for 2 weeks). The purpose of exercise therapy will be to stretch the muscles, strengthen them and maintain flexibility. During the treatment of lateral epicondylitis, home exercises will be beneficial when performed twice a day for at least three months, and stretching exercises will be performed first, and then strengthening exercises will be started in a controlled manner.

Group 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-65 years with pain in the lateral humeral epicondyle region for at least 6 weeks
  • Patients with pain on palpation of the lateral humeral epicondyle and patients with lateral epicondyle pain manifested by at least one of the provocative tests, such as resistant middle finger extension or resistant wrist extension or passively stretching the wrist extensors
  • Patients with painful trigger points detected by palpation in the extensor group muscles of the forearm

You may not qualify if:

  • History of upper extremity trauma or surgery
  • History of arthritis in the upper extremity
  • Patients with EMG-proven entrapment neuropathy in the upper extremity
  • Patients with cervical radiculopathy
  • History of interventional procedures such as physical therapy or steroid injection for lateral epicondylitis in the last 3 months
  • Pregnancy and pregnancy
  • Patients with complaint duration less than 6 weeks
  • Having mental (intelligence-related) problems, limitation of cooperation-orientation (being aware of time and space and having communication skills)
  • \<18 years, \>65 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan 2. Abdulhamid Han Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Interventions

SplintsSteroidsDry Needling

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation DevicesFused-Ring CompoundsPolycyclic CompoundsComplementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Emre Ata, Ass.Prof.

    Sultan II. Abdulhamidhan Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ömer Faruk Ünelli, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffesor

Study Record Dates

First Submitted

March 31, 2022

First Posted

August 17, 2022

Study Start

February 2, 2021

Primary Completion

June 2, 2023

Study Completion

August 2, 2023

Last Updated

August 17, 2022

Record last verified: 2022-08

Locations