The Effectiveness of Manipulation Treatment in Cervical Region
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cervicothoracic thrust manipulation
Cervicothoracic thrust manipulation sham
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Tape, Pain, Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis Nonspecific neck pain (NSNP)
- Symptoms should last longer than 2 weeks
Exclusion Criteria:
- Any known cause such as radiculopathy or neurological diseases,
- History of neck surgery,
- History of vertebral fracture,
- Osteoporosis,
- Tumor or a mass in the vertebral column,
- Any spinal thrust manipulation contraindication,
- Medication usage such as antiinflammatory or analgesic which might effect outcome assessments,
- History of spinal manipulation
Sites / Locations
- Abant Izzet Baysal University
- Health Sciences Faculty Bolu Abant Izzet Baysal University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intervention Group
Control Group
Arm Description
A single-session manipulation with a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied each week for two weeks.
A sham manipulation without a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied.
Outcomes
Primary Outcome Measures
Pain pressure threshold
Pain pressure threshold (PPT). was assessed with an analogue algometry (Baseline, FEl Inc. White Plains, NY,USA) with 1 cm2 rubber tip was used to measure the pain pressure threshold. Algometer perpendicularly placed over spinous process of T1 on prone position and pressure progressively increased 1 kg/s until patients verbally reported pain under the tip of algometer or referring pain. Measurement repeated three times and average score recorded.
Secondary Outcome Measures
Visual analog scale
The patient was asked to mark the severity of his or her pain with active motion on a horizontal line 100 millimeters in length. The intensity of the pain was calculated by measuring the area in which the individual marked between 0 (no pain) and 10 (the most severe pain I felt in my life).
Cervical range of motion
Cervical Range of Motion (ROM) of flexion,extension, lateral flexion and rotation were measured with basic cervical ROM device (Performance Attainment, Associates, St Paul, MN, USA) in seated position without back support.
Neck Disability Index
Perceived disability of patients was assessed with 10-item item Neck Disability Index (NDI),which a modified from Oswestry Low Back Pain Disability Index to assess with a score range of 0 to 50.
Global Perceived Effect Scale
Change in the perception of the symptoms after the treatment was measured by a Global Perceived Effect Scale. Patients were asked to rate change between 1 completely recovered, 4 unchanged, 7 vastly worse on a horizontal likert scale.
Full Information
NCT ID
NCT04455048
First Posted
June 29, 2020
Last Updated
September 22, 2023
Sponsor
Abant Izzet Baysal University
1. Study Identification
Unique Protocol Identification Number
NCT04455048
Brief Title
The Effectiveness of Manipulation Treatment in Cervical Region
Official Title
The Effectiveness of Manipulation Treatment in Acute Cervical Region Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 2, 2019 (Actual)
Primary Completion Date
March 16, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neck pain is the second most common musculoskeletal pain after lumbar pain. Prevalence is 27.2% female and 17.4% in male population (1, 2). Approximately 1/3 of acute onset neck aches become chronic. It causes increasing the cost of treatment and also the loss of labor (3, 4).
Detailed Description
Acute neck pain is often caused by mechanical causes and can be classified as rheumatic diseases, infectious and tumoral pathologies, metabolic bone diseases such as osteoporosis and osteomalacia, pain reflected the cervical region. A-V malformation and syringomyelia are the causes of chronic cervical pain (5). Mechanical neck pain is a non-radicular pain caused by local musculoskeletal structures and is characterized by a spasm of the cervical muscles. (6, 7). Posture, emotional stress, cold and fatigue are etiologic causes, and pain is also reflected in the cervical, occipital and scapular regions depending on the severity of muscle spasm and the presence of trigger point in myofascial pain syndrome (9, 10). Many authors have suggested that facet joints are associated with mechanical dysfunction as a common cause of cervical pain (8-10).
The pain in the head and neck region affects the quality of life, cognitive and functional status of the person. The most important difficulty and failure in the treatment of such pain arise from the inability to diagnose the disease correctly. Good anatomical and biomechanical properties of the region, comprehensive anamnesis, physical examination under static and dynamic conditions, laboratory and radiological examinations are the most important milestones of diagnosis (12). In most cases, medical treatment and physical therapy modalities (superficial and deep heat, electrotherapy, laser, traction, massage, spa) are sufficient for pain relief and recovery of function, but interventional procedures and surgical procedures are needed for the fewer patient. Recently, spinal mobilization and manipulation techniques can be used to relieve pain and restore function in the early stages. Although it is a safe method, in order to prevent the rare complications it is necessary to determine the indications of treatment correctly, to exclude contiguous cases and to apply the manipulation by experts (12).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Tape, Pain, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups with a sham control. Assessments will be performed before manipulation, immediately after first session, in the second week, and two months after the last session.
Masking
ParticipantOutcomes Assessor
Masking Description
The manipulation group will receive a single session thrust manipulation and the control group will receive a sham manipulation. Outcome assessment will be performed by another investigator.
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
A single-session manipulation with a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied each week for two weeks.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
A sham manipulation without a high-speed low-amplitude thrust technique in the cervicothoracic transition region will be applied.
Intervention Type
Other
Intervention Name(s)
Cervicothoracic thrust manipulation
Intervention Description
The patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. Thrust manipulation will be applied at the end of exhale.
Intervention Type
Other
Intervention Name(s)
Cervicothoracic thrust manipulation sham
Intervention Description
The patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. A soft compression will be applied at the end of exhale without a thrust.
Primary Outcome Measure Information:
Title
Pain pressure threshold
Description
Pain pressure threshold (PPT). was assessed with an analogue algometry (Baseline, FEl Inc. White Plains, NY,USA) with 1 cm2 rubber tip was used to measure the pain pressure threshold. Algometer perpendicularly placed over spinous process of T1 on prone position and pressure progressively increased 1 kg/s until patients verbally reported pain under the tip of algometer or referring pain. Measurement repeated three times and average score recorded.
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Visual analog scale
Description
The patient was asked to mark the severity of his or her pain with active motion on a horizontal line 100 millimeters in length. The intensity of the pain was calculated by measuring the area in which the individual marked between 0 (no pain) and 10 (the most severe pain I felt in my life).
Time Frame
two weeks
Title
Cervical range of motion
Description
Cervical Range of Motion (ROM) of flexion,extension, lateral flexion and rotation were measured with basic cervical ROM device (Performance Attainment, Associates, St Paul, MN, USA) in seated position without back support.
Time Frame
two weeks
Title
Neck Disability Index
Description
Perceived disability of patients was assessed with 10-item item Neck Disability Index (NDI),which a modified from Oswestry Low Back Pain Disability Index to assess with a score range of 0 to 50.
Time Frame
two weeks
Title
Global Perceived Effect Scale
Description
Change in the perception of the symptoms after the treatment was measured by a Global Perceived Effect Scale. Patients were asked to rate change between 1 completely recovered, 4 unchanged, 7 vastly worse on a horizontal likert scale.
Time Frame
two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis Nonspecific neck pain (NSNP)
Symptoms should last longer than 2 weeks
Exclusion Criteria:
Any known cause such as radiculopathy or neurological diseases,
History of neck surgery,
History of vertebral fracture,
Osteoporosis,
Tumor or a mass in the vertebral column,
Any spinal thrust manipulation contraindication,
Medication usage such as antiinflammatory or analgesic which might effect outcome assessments,
History of spinal manipulation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erdal Dilekçi, MD
Organizational Affiliation
Bolu Abant Izzet Baylsa University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ramazan KURUL, Ph.D
Organizational Affiliation
Bolu Abant Izzet Baylsa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abant Izzet Baysal University
City
Bolu
State/Province
Merkez
ZIP/Postal Code
14100
Country
Turkey
Facility Name
Health Sciences Faculty Bolu Abant Izzet Baysal University
City
Bolu
State/Province
Merkez
ZIP/Postal Code
14100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared after study publicaiton with online link.
IPD Sharing Time Frame
Data will be available after study published and will be available indefinetly.
IPD Sharing Access Criteria
data will be accessed from cloud store link
Learn more about this trial
The Effectiveness of Manipulation Treatment in Cervical Region
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