- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06858605
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
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)
June 15, 2022
Primary Completion (Actual)
July 20, 2022
Study Completion (Actual)
April 10, 2023
Study Registration Dates
First Submitted
February 24, 2025
First Submitted That Met QC Criteria
February 27, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 27, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Cervical Disc Herniation
-
Inonu UniversityRecruitingCervical Disc HerniationTurkey (Türkiye)
-
Holger JoswigCompletedLumbar Disc Herniation | Cervical Disc HerniationSwitzerland
-
Janbubi JandaulyetRecruitingCervical Disc Herniation | Cervical Radicular Pain | Facet TropismTurkey
-
Marmara UniversityRecruiting
-
Jaseng Medical FoundationCompletedCervical Disc HerniationKorea, Republic of
-
Marmara UniversityCompletedCervical Disc HerniationTurkey
-
Samsun UniversityCompletedCervical Disc Disease | Cervical Disc Herniation | Cervical StenosisTurkey
-
Baskent University Ankara HospitalCompletedCervical Disc HerniationTurkey
-
Centre Hospitalier Régional de la CitadelleNot yet recruitingCervical Disc Herniation | Cervical Foraminal Stenosis
-
Yonsei UniversityCompletedCervical Disc Herniation | Cervical Spinal Stenosis | Cervical Spine DamageKorea, Republic of
Clinical Trials on Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT)
-
Fisioterapia Manual OrtopedicaCompletedTemporomandibular Disorder | Manual TherapyMexico
-
Youngstown State UniversityFranklin Pierce UniversityRecruitingCervicogenic HeadacheUnited States
-
University of JaénCompleted
-
Texas Woman's UniversityRecruitingChronic Pain | Pelvic Pain | Muscle TightnessUnited States