Effect of Neck vs. Combined Neck-Lumbar Mobilization on Pain and Motion in Cervical Disc Herniation

February 27, 2025 updated by: Başar Öztürk, Fenerbahce University

The Effect of Neck Mobilization vs. Combined Neck and Lumbar Mobilization on Pain and Range of Motion in People With Cervical Disc Herniation: A Randomized Controlled Study

Background To assess the effectiveness of Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT) applied to cervical-only mobilization versus both lumbar and cervical regions on pain intensity and range of motion (ROM) in individuals with cervical disc herniation, Methods: Thirty three participants were enrolled in the study. The patients were randomly assigned to two groups. Group A received cervical-only KEOMT while Group B received combined lumbar and cervical KEOMT, Interventions were administered three times a week for four weeks. Pain was measured using the Visual Analog Scale (VAS), ROM was assessed for flexion and lateral flexion, and Neck Pain and Disability Index (NPDI) and Short-Form 36 Health Survey (SF-36) were used for evaluation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • İstanbul, Turkey
        • Fenerbahçe University Faculty of Health Sciences Physiotherapy Department

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with cervical disc herniation at least 8 weeks but not more than 5 years prior.
  • Cervical disc herniation verified by magnetic resonance imaging (MRI) at 1 or 2 segmental levels, consistent with clinical findings.
  • Neck Disability Index (NDI) score greater than 5.
  • No use of analgesic medication other than the prescribed treatment before or during the study period.

Exclusion Criteria:

  • History of myelopathy, whiplash-associated disorder, generalized myalgia, malignant tumor, or inflammatory disease.
  • Painful back problems or neurological symptoms within the past year.
  • Psychiatric disorders or drug abuse.
  • Contraindications to physical therapy or inability to return to work or perform physical therapy due to other diseases or disabilities.
  • Inability to communicate effectively.
  • Participation in any additional interventions outside the prescribed treatment during the study period.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A (Cervical mobilization group)
Cervical mobilizations were performed with patients in a supine position. This setup facilitated accurate application of manual therapy techniques. Techniques included Grade 1 mobilizations (pain relief) and Grade 2 mobilizations (soft tissue relaxation). The concave-convex rule guided gliding and translatory movements for optimizing joint mechanics. Manual traction and segmental mobilization were performed with patients in a supine position. The KEOMT included cervical segmental traction and cervical segmental mobilization-flexion and gliding therapy in grade 3. The Convex/Concave Rule was consistently applied in all cases.
Other: Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT)
Kaltenborn's biomechanical approach to diagnosis and treatment emphasizes ergonomic principles and trial-based techniques. His mobilization methods, classified into Grades I-III, target pain relief (Grades I-II) and joint hypomobility (Grade III) by enhancing glide and tissue elasticity. The Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT) further refines this approach using arthrokinematic principles to restore physiological joint motion based on the concave-convex rule.
Experimental: Group B (Combined cervical and lumbar mobilization group)
For segmental flexion mobilization, the patient is positioned on their side with their hips and knees flexed. The therapist places one hand on the vertebrae, positioning the fingers on either the transverse or spinous processes, and the other hand on the sacrum in a similar manner. To facilitate movement, the therapist's chest makes contact with the patient's knees, allowing the pelvis to be guided in a caudal or ventral direction. This technique can be effectively adapted for both cervical and lumbar regions, maintaining consistent application across various spinal segments. For segmental traction, the patient also lies on their side, with their knees flexed toward the abdomen. The therapist hooks their fingers over the proximal transverse processes or the soft tissues in the paravertebral region and applies traction by pulling in opposite directions.
Other: Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT)
Kaltenborn's biomechanical approach to diagnosis and treatment emphasizes ergonomic principles and trial-based techniques. His mobilization methods, classified into Grades I-III, target pain relief (Grades I-II) and joint hypomobility (Grade III) by enhancing glide and tissue elasticity. The Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT) further refines this approach using arthrokinematic principles to restore physiological joint motion based on the concave-convex rule.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visuel Analog Scale
Time Frame: Through study completion, an average of 1 year
Pain intensity was evaluated with a visual analog scale (VAS). A 10 cm visual scale was divided into equal segments and numbered from 0 to 10. Patients were instructed that 0 represents no pain, while 10 indicates unbearable pain. Based on this explanation, they were asked to rate their pain intensity accordingly
Through study completion, an average of 1 year
Range of motion
Time Frame: Through study completion, an average of 1 year
A universal goniometer was used to measure joint position and range of motion, following the guidelines of Kendall and the American Association of Orthopedic Surgeons. The assessment was conducted with the patient in a sitting position. Patients were instructed to actively perform movements of cervical flexion, extension, right and left rotation, and right and left lateral flexion, with the corresponding degrees of motion recorded.
Through study completion, an average of 1 year
Neck Pain and Disability Assessment
Time Frame: Through study completion, an average of 1 year
Neck pain and disability were evaluated using the Neck Pain Disability Index (NPDI), a validated tool developed by Vernon and Mior (1991). The index comprises 20 items scored on a Visual Analog Scale (VAS), assessing the impact of neck pain on daily activities, occupational performance, and emotional well-being. Scores range from 0 (no disability) to 100 (complete disability), with higher scores indicating greater functional limitations. This study employed the Turkish version of the NPDI, which has demonstrated reliability
Through study completion, an average of 1 year
Quality of life scale
Time Frame: Through study completion, an average of 1 year
The participants' quality of life was assessed using the Short Form 36 (SF-36), a self-reported scale developed by the Rand Corporation in 1992. The SF-36 evaluates general health status through 36 questions, divided into 8 subscales: physical function, physical role limitations, bodily pain, general health, vitality, social function, emotional well-being, and mental health. Scores on the SF-36 range from 0 to 100, with 0 representing the worst health status and 100 representing the best. The Turkish version of the scale was used in this study
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fenerbahce University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • fztduygu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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