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Completed

NCT Number: NCT06858605

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

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.

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Key information

Conditions

Cervical Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Neck Pain Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fenerbahçe University Faculty of Health Sciences Physiotherapy Department

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Fenerbahce University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Mar 5, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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