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CompletedNCT05744778Updated Sep 28, 2023

The Effect of Dry Needling Treatment Combined With Physical Therapy in Patients With Cervical Spondylosis

An interventional study of Dry needling and Physical therapy and rehabilitation in Dry Needling, Cervical Spondylosis and Physical Therapy, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Dry Needling
  • Cervical Spondylosis
  • Physical Therapy

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03

In context

Spondylosis

144 studies on the registry are indexed under Spondylosis; 41 are open to participants now.

This study's enrollment of 70 is above the median of 60 across 99 interventional studies indexed under Spondylosis.

Browse Spondylosis studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 680 studies on the registry; 208 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Physical therapy and rehabilitation

    The patient group who underwent physical therapy and rehabilitation.

    Other: Physical therapy and rehabilitation

  • Experimental
    Dry needling

    The patient group who underwent dry needling for trigger points in the upper trapezius muscle along with physical therapy and rehabilitation.

    Other: Dry needling · Other: Physical therapy and rehabilitation

Interventions

  • OtherDry needling

    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.

  • OtherPhysical therapy and rehabilitation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

Secondary outcomes

  1. 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.

    Time frame: 1 day

  2. 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.

    Time frame: 1 day

  3. 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.

    Time frame: 1 day

  4. 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.

    Time frame: 1 day

07

Study locations

1 site
  • Istanbul Training and Research Hospital
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05744778
Lead sponsor
Istanbul University - Cerrahpasa
Collaborators
Istanbul Training and Research Hospital
Responsible party
Alper mengi (Medical Doctor, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Feb 27, 2023
Start date
Feb 1, 2023
Primary completion
Jun 1, 2023
Completion
Jun 1, 2023
Last update
Sep 28, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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