Effectiveness of Chiropractic Cervical Manipulation in Lateral Epicondylitis

March 7, 2024 updated by: Mesut Arslan

The Effect of Chiropractic Cervical Manipulation on Pain, Functionality and Grip Strength in Patients With Lateral Epicondylitis

İt is aimed to examine the effect of chiropractic cervical manipulation on pain, functionality and grip strength in patients with lateral epicondylitis and whether it is preferable to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lateral Epicondylitis (LE) is known as chronic symptomatic degeneration of the forearm common extensor tendon attachment at the humeral ectochondyle. It is one of the most common overuse syndromes today and is characterized by loss of function and pain due to an inflammatory reaction that occurs during stretching of the condyle.

The main goals of the treatments are to relieve pain, reduce overload on the arm and elbow joints, accelerate the healing process and enable the patient to regain functionality in daily life activities at the optimum time. Many treatment methods have been applied for this purpose, and the number of studies on the effectiveness of manual applications is increasing. Among manual applications, chiropractic applications have recently attracted attention.

Study Type

Interventional

Enrollment (Actual)

50

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 Locations

  • Turkey
      • Bitlis, Turkey, 13000
        • Bitlis Eren University

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:

  • (1) age between 20-50 years,
  • (2) dominant right extremity and ipsilateral lateral epicondylitis,
  • (3) full range of motion in the cervical region,

Exclusion Criteria:

  • (1) spinal root compression (radiculopathy),
  • (2) neurologic symptoms such as loss of strength in the lower extremities, upper extremities and face, numbness, involuntary movements, abnormal gait pattern, dizziness, nausea/vomiting of unknown cause, swallowing and speech difficulties,
  • (3) pregnancy,
  • (4) presence of active malignancies,
  • (5) positive pre- manipulative vertebrobasilar insufficiency test,
  • (6) use of anticoagulant and antiaggregant drugs,
  • (7) history of previous cervical surgery or whiplash,
  • (8) acute inflammatory disease,
  • (9) positive results of the test performed before manipulation in the cervical spine (foraminal compression test,
  • (10) any deformity in the New York Posture analysis,
  • (11) unwillingness to participates

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chiropractic Cervical Manipulation Group (CCMG)
Patients in both groups were placed in supine position and manipulation was applied to patients in the chiropractic cervical manipulation group.
Other: Chiropractic Cervical Manipulation
In the chiropractic cervical manipulation group, the patient was placed in the supine position. The therapist moved to the patient's head, identified the C5-C6 segment by palpation, and manually performed spinal manipulation from the right side using the "cervical rotary break/index push" technique since the dominant side of the patients was the right extremity. In the cervical rotary break/index thrust technique, the lateral aspect of the practitioner's index finger was placed in contact with the posterior aspect of the participant's C5 facet joint, and a rotational thrust was performed between the C5-C6 vertebrae.
Sham Comparator: Control Group (CG)
Patients in both groups were placed in supine position and manipulation was applied to patients in the chiropractic cervical manipulation group.
Other: Sham Technique Practice
The sham technique can be defined as a technique that does not have any therapeutic effect and is preferred to determine whether the efficacy of another technique is superior. The patient was placed in the supine position. The therapist moved to the patient's head, and the C5-C6 segment localized in the lower cervical region was detected by palpation. The C5-C6 segment was positioned to perform chiropractic cervical manipulation and waited for 30 seconds without any pushing force.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Pain Scale (NPS)
Time Frame: Pain was evaluated immediately before and immediately after the application.
The patient is asked to indicate the value of their pain on the scale. During the assessment, an 11-point scale is used, with "0" representing "no pain" and "10" meaning "the most severe pain imaginable".
Pain was evaluated immediately before and immediately after the application.
Grip Strength
Time Frame: Grip Strength parameter was evaluated immediately before and immediately after the application.
Consistent with the American Hand Therapy Association's hand grip dynamometer recommendations and previous research, participants sat in a chair with the device in the dominant hand, wrists in a neutral position and elbows bent at a 90° angle. Three repeated measurements were taken, and averages were calculated.
Grip Strength parameter was evaluated immediately before and immediately after the application.
Patient Rated Tennis Elbow Evaluation (PRTEE)
Time Frame: PRTEE parameter was evaluated immediately before and immediately after the application.
A 15-item questionnaire was used to evaluate pain and disability. The questionnaire includes three subscales, with each item scored from 0 to 10. The total score ranges from 0 to 100, where higher scores indicate more pain and disability.
PRTEE parameter was evaluated immediately before and immediately after the application.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mesut Arslan

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)

October 30, 2018

Primary Completion (Actual)

January 3, 2019

Study Completion (Actual)

January 3, 2019

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LE-CCM

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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