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NCT Number: NCT06300749

Effectiveness of Chiropractic Cervical Manipulation in 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.

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Key information

Conditions

Lateral Epicondylitis Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bitlis Eren University

Bitlis, 13000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chiropractic Cervical Manipulation

Other

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 Technique Practice

Other

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.

Primary outcomes

  1. 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".

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Mesut Arslan

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2024
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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