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Completed

NCT Number: NCT05744778

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

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.

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Key information

Conditions

Dry Needling Bone Diseases Cervical Spondylosis Musculoskeletal Diseases Physical Therapy Spinal Diseases Spondylosis

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

dry needling

Other

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.

Physical therapy and rehabilitation

Other

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 outcomes

  1. Pain severity

    Time frame: 1 day

    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 outcomes

  1. Number of active trigger points

    Time frame: 1 day

    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.

  2. Functional status

    Time frame: 1 day

    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.

  3. Life quality

    Time frame: 1 day

    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.

  4. Anxiety and depression

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

  • Istanbul Training and Research Hospital

Registry information

Official study title

The Effect of Dry Needling Treatment Combined With Physical Therapy in Patients With Cervical Spondylosis: A Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 27, 2023
Registry last updated
Sep 28, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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