Effectiveness of Chiropractic Cervical Manipulation in Lateral Epicondylitis

NCT06300749 | Completed

• 1 other identifier: LE-CCM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lateral Epicondylitis

Keywords

Lateral Epicondylitis; Chiropractic Cervical Manipulation

Outcome Measures

Primary Outcomes (3)

• Numerical Pain Scale (NPS)

  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

  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)

  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.

Study Arms (2)

Chiropractic Cervical Manipulation Group (CCMG)

EXPERIMENTAL

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

Control Group (CG)

SHAM COMPARATOR

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

Interventions

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.

Chiropractic Cervical Manipulation Group (CCMG)

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.

Control Group (CG)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• (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

Sponsors & Collaborators

• Mesut Arslan: lead

Study Sites (1)

Bitlis Eren University

Bitlis, 13000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 8, 2024
• Study Start: October 30, 2018
• Primary Completion: January 3, 2019
• Study Completion: January 3, 2019
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)