Back to resultsThe Effect of Dry Needling Treatment Combined With Physical Therapy in Patients With Cervical Spondylosis
Primary Purpose
Dry Needling, Cervical Spondylosis, Physical Therapy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dry needling
Physical therapy and rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Dry Needling
Eligibility Criteria
Inclusion Criteria: Having neck pain for at least 3 months Restriction of neck movements and/or pain during movement Tenderness in neck paravertebral muscles and neural foramen with compression Detection of narrowing of intervertebral disc spaces, subchondral sclerosis, osteophyte on cervical radiograph Active trigger point in the upper trapezius muscle during the examination. Exclusion Criteria: Having motor, sensory or reflex abnormalities due to spinal root compression Whiplash injuries Cervical spinal stenosis Having undergone cervical vertebra surgery History of interventional procedure on the cervical region in the last 6 months Central or peripheral nervous system disorders Spondylolisthesis Inflammatory neck pain History of infectious, chronic inflammatory disease, malignancy Not being cooperative Having open wounds, infections or sensory defects on the skin where the application will be made Fibromyalgia Advanced osteoporosis or osteomalacia Active psychiatric illness.
Sites / Locations
- Istanbul Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Physical therapy and rehabilitation
Dry needling
Arm Description
The patient group who underwent physical therapy and rehabilitation.
The patient group who underwent dry needling for trigger points in the upper trapezius muscle along with physical therapy and rehabilitation.
Outcomes
Primary Outcome Measures
Pain severity
Pain intensity will be questioned by visual analog scale (VAS) as pain intensity at movement, rest, and night. A horizontal straight line 10 cm long will be used in the VAS assessment. 0 will be considered as no pain, 10 will be considered as the most severe pain. Movement pain will be questioned as the average of the pain felt while the patients are doing their daily routine, rest pain will be the average of the pain felt when the patients are not doing any activity during the day, and night pain will be the average of the neck pain when they wake up or wake up from sleep.
Secondary Outcome Measures
Number of active trigger points
The upper trapezius muscle of the patient lying in the prone position will be examined and the location and number of active trigger points determined as a result of the examination will be recorded.
Functional status
The Neck Pain and Disability Scale (NPAD) will be used to measure the functional status of patients due to neck pain. NPAD consists of 20 questions including the effect of neck pain on emotional state and cognitive function and the relationship of neck pain with daily living activities. Each question takes a value between 0 and 5. Accordingly, 0 represents normal function and 5 represents the worst condition resulting from the pain problem. The total score of the scale, which takes a value between 0 and 100, is obtained by summing the scores of all questions.
Life quality
Short Form-12 (SF-12) will be used to evaluate the quality of life of the patients. SF-12 was created as a shorter form by taking 12 different items from 8 different subheadings of SF-36. It has 2 sub-parameters as physical and mental health. Higher scores indicate better health.
Anxiety and depression
Patients will be evaluated with the Hospital Anxiety and Depression Score (HADS) in terms of anxiety and depression. HADS consists of 14 questions in total. The minimum score for the anxiety and depression subscales is 0, and the maximum score is 21. An increase in the score on the scale means that the severity of anxiety and depression increases. The cut-off points were determined as 10 for the anxiety subscale and 7 for the depression subscale.
Full Information
NCT ID
NCT05744778
First Posted
February 16, 2023
Last Updated
September 26, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Istanbul Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05744778
Brief Title
The Effect of Dry Needling Treatment Combined With Physical Therapy in Patients With Cervical Spondylosis
Official Title
The Effect of Dry Needling Treatment Combined With Physical Therapy in Patients With Cervical Spondylosis: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
June 1, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Istanbul Training and Research Hospital
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
In this study, it was aimed to determine whether dry needling treatment applied to the trigger points in the trapezius muscle in patients with chronic neck pain due to cervical spondylosis makes an additional contribution to the treatment results of the physical therapy and rehabilitation program.
Detailed Description
Among the evaluated patients, the patients meeting the inclusion and exclusion criteria will be randomized into 2 groups using the random numbers table.
While physical therapy and rehabilitation program will be applied to one group, dry needling treatment will be applied to the trigger points in the upper trapezius region with the same program to the other group. Patients will be evaluated before treatment (day 0) and at the end of treatment (day 21).
The randomization and evaluation of the patients will be done by Gül Tuğba Bulut, while the injection of the patients will be done by Alper Mengi.
Gender, age, education level, occupation, neck pain duration, body mass index of the patients included in the study will be recorded.
The patients will be evaluated in terms of pain intensity, number of active trigger points in the upper trapezius muscle, functional status, quality of life, anxiety and depression at before (day 0) and after treatment (day 21).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Needling, Cervical Spondylosis, Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical therapy and rehabilitation
Arm Type
Experimental
Arm Description
The patient group who underwent physical therapy and rehabilitation.
Arm Title
Dry needling
Arm Type
Experimental
Arm Description
The patient group who underwent dry needling for trigger points in the upper trapezius muscle along with physical therapy and rehabilitation.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
In addition to the physical therapy and exercise program, the dry needling group will consist of patients who have had 3 sessions of dry needling applied to the trigger points in the trapezius muscle, 5 days apart.
Intervention Type
Other
Intervention Name(s)
Physical therapy and rehabilitation
Intervention Description
The physical therapy and rehabilitation group will consist of patients who will be applied the same exercise program together with the same physical therapy applications (superficial heat (infrared lamp), transcutaneous electrical nerve stimulation (TENS) and therapeutic ultrasound (TUS)) 5 sessions per week for 3 weeks.
Primary Outcome Measure Information:
Title
Pain severity
Description
Pain intensity will be questioned by visual analog scale (VAS) as pain intensity at movement, rest, and night. A horizontal straight line 10 cm long will be used in the VAS assessment. 0 will be considered as no pain, 10 will be considered as the most severe pain. Movement pain will be questioned as the average of the pain felt while the patients are doing their daily routine, rest pain will be the average of the pain felt when the patients are not doing any activity during the day, and night pain will be the average of the neck pain when they wake up or wake up from sleep.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Number of active trigger points
Description
The upper trapezius muscle of the patient lying in the prone position will be examined and the location and number of active trigger points determined as a result of the examination will be recorded.
Time Frame
1 day
Title
Functional status
Description
The Neck Pain and Disability Scale (NPAD) will be used to measure the functional status of patients due to neck pain. NPAD consists of 20 questions including the effect of neck pain on emotional state and cognitive function and the relationship of neck pain with daily living activities. Each question takes a value between 0 and 5. Accordingly, 0 represents normal function and 5 represents the worst condition resulting from the pain problem. The total score of the scale, which takes a value between 0 and 100, is obtained by summing the scores of all questions.
Time Frame
1 day
Title
Life quality
Description
Short Form-12 (SF-12) will be used to evaluate the quality of life of the patients. SF-12 was created as a shorter form by taking 12 different items from 8 different subheadings of SF-36. It has 2 sub-parameters as physical and mental health. Higher scores indicate better health.
Time Frame
1 day
Title
Anxiety and depression
Description
Patients will be evaluated with the Hospital Anxiety and Depression Score (HADS) in terms of anxiety and depression. HADS consists of 14 questions in total. The minimum score for the anxiety and depression subscales is 0, and the maximum score is 21. An increase in the score on the scale means that the severity of anxiety and depression increases. The cut-off points were determined as 10 for the anxiety subscale and 7 for the depression subscale.
Time Frame
1 day
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having neck pain for at least 3 months
Restriction of neck movements and/or pain during movement
Tenderness in neck paravertebral muscles and neural foramen with compression
Detection of narrowing of intervertebral disc spaces, subchondral sclerosis, osteophyte on cervical radiograph
Active trigger point in the upper trapezius muscle during the examination.
Exclusion Criteria:
Having motor, sensory or reflex abnormalities due to spinal root compression
Whiplash injuries
Cervical spinal stenosis
Having undergone cervical vertebra surgery
History of interventional procedure on the cervical region in the last 6 months
Central or peripheral nervous system disorders
Spondylolisthesis
Inflammatory neck pain
History of infectious, chronic inflammatory disease, malignancy
Not being cooperative
Having open wounds, infections or sensory defects on the skin where the application will be made
Fibromyalgia
Advanced osteoporosis or osteomalacia
Active psychiatric illness.
Facility Information:
Facility Name
Istanbul Training and Research Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Dry Needling Treatment Combined With Physical Therapy in Patients With Cervical Spondylosis
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