Lateral EpicondylitisNCT06300749
Effectiveness of Chiropractic Cervical Manipulation in Lateral Epicondylitis
A study testing Chiropractic Cervical Manipulation in people with Lateral Epicondylitis, run by Mesut Arslan at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Chiropractic Cervical Manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2018to 3 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (1) age between 20-50 years,
- (2) dominant right extremity and ipsilateral lateral epicondylitis,
- (3) full range of motion in the cervical region,
Who cannot join
- (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,
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- (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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lateral Epicondylitis
- Being tested
- Chiropractic Cervical Manipulation, Sham Technique Practice
- Keywords
- Lateral Epicondylitis, Chiropractic Cervical Manipulation
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic Cervical ManipulationOther
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 PracticeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Technique Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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.
Measured: PRTEE parameter was evaluated immediately before and immediately after the application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start30 Oct 2018
- Primary completion3 Jan 2019
- Study completion3 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesut Arslan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mesut Arslan, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300749
- Sponsor's protocol ID
- LE-CCM
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chiropractic Cervical Manipulation on Pain, Functionality and Grip Strength in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT06300749
- Acronym / sponsor ID
- LE-CCM
- Conditions
- Lateral Epicondylitis
- Keywords
- Lateral Epicondylitis, Chiropractic Cervical Manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mesut ArslanUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiropractic Cervical Manipulation Group (CCMG) | Experimental | Other: Chiropractic Cervical ManipulationPatients in both groups were placed in supine position and manipulation was applied to patients in the chiropractic cervical manipulation group. |
| Control Group (CG) | Sham comparator | Other: Sham Technique PracticePatients in both groups were placed in supine position and manipulation was applied to patients in the chiropractic cervical manipulation group. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- (1) age between 20-50 years,
- (2) dominant right extremity and ipsilateral lateral epicondylitis,
- (3) full range of motion in the cervical region,
Key exclusion criteria (11 listed)
- (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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chiropractic Cervical ManipulationIn 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. | Other | Chiropractic Cervical Manipulation Group (CCMG) |
| Sham Technique PracticeThe 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. | Other | Control Group (CG) |
Primary outcome
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".
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic Cervical Manipulation in people with Lateral Epicondylitis, run by Mesut Arslan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Scale (NPS) (time frame: Pain was evaluated immediately before and immediately after the application.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.