Cervical Disc HerniationNCT06858605
Effect of Neck vs. Combined Neck-Lumbar Mobilization on Pain and Motion in Cervical Disc Herniation
A study testing Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT) in people with Cervical Disc Herniation, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Cervical Disc Herniation
- What is being tested?
- Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 10 Apr 2023
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fenerbahçe University Faculty of Health Sciences Physiotherapy Department
Istanbul
About this study
Official title: 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.
- Conditions
- Cervical Disc Herniation
- Being tested
- Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT)
- Keywords
- Intervertebral Disc Displacement, Musculoskeletal Manipulations, Range of Motion, Articular, Neck pain
- Medical subject headings
- Intervertebral Disc Displacement, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Cervical mobilization group) | Experimental | 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. Receives: Other: Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT) |
| Group B (Combined cervical and lumbar mobilization group) | Experimental | 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. Receives: Other: Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visuel Analog Scale
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
Measured: Through study completion, an average of 1 year
Range of motion
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.
Measured: Through study completion, an average of 1 year
Neck Pain and Disability Assessment
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
Measured: Through study completion, an average of 1 year
Quality of life scale
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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start15 Jun 2022
- Primary completion20 Jul 2022
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Disc HerniationStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- 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
- Model description
- After obtaining informed consent forms from the participants who accepted to join the study, participants were randomly assigned to two groups-Group A (cervical-only KEOMT) and Group B (combined cervical and lumbar KEOMT)-using a computer-generated randomization sequence. Block randomization was employed to ensure balanced group sizes.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Başar Öztürk, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858605
- Sponsor's protocol ID
- fztduygu
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ozdincler A, Aktas D, Aktar Reyhanioglu D, Ozturk B. 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. J Bodyw Mov Ther. 2025 Sep;43:188-195. doi: 10.1016/j.jbmt.2025.04.032. Epub 2025 Apr 26.
PubMed 40483122
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06858605
- Acronym / sponsor ID
- fztduygu
- Conditions
- Cervical Disc Herniation
- Keywords
- Intervertebral Disc Displacement, Musculoskeletal Manipulations, Range of Motion, Articular, Neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 5 Mar 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After obtaining informed consent forms from the participants who accepted to join the study, participants were randomly assigned to two groups-Group A (cervical-only KEOMT) and Group B (combined cervical and lumbar KEOMT)-using a computer-generated randomization sequence. Block randomization was employed to ensure balanced group sizes.
| Arm | Type | Receives |
|---|---|---|
| Group A (Cervical mobilization group) | Experimental | Other: Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT)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. |
| Group B (Combined cervical and lumbar mobilization group) | Experimental | Other: Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT)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. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| 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. | Other | Group A (Cervical mobilization group), Group B (Combined cervical and lumbar mobilization group) |
Primary outcome
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
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.
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
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
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 5 Mar 2025.
- Derived from this study: PubMed 40483122Ozdincler A, Aktas D, Aktar Reyhanioglu D, Ozturk B. 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. J Bodyw Mov Ther. 2025 Sep;43:188-195. doi: 10.1016/j.jbmt.2025.04.032. Epub 2025 Apr 26.
- Individual participant dataSharing planned: Undecided
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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 Kaltenborn-Evjenth Orthopedic Manual Therapy (KEOMT) in people with Cervical Disc Herniation, run by Fenerbahce University 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 4 inclusion and 6 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 5 Mar 2025. 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. 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?
Visuel Analog Scale (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06858605, which also lists 1 linked publication.
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 5 Mar 2025.