NCT05744778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

February 16, 2023

Last Update Submit

September 26, 2023

Conditions

Dry NeedlingCervical SpondylosisPhysical Therapy

Outcome Measures

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.

    1 day

Secondary Outcomes (4)

  • Number of active trigger points

    1 day

  • Functional status

    1 day

  • Life quality

    1 day

  • Anxiety and depression

    1 day

Study Arms (2)

Physical therapy and rehabilitation

EXPERIMENTAL

The patient group who underwent physical therapy and rehabilitation.

Other: Physical therapy and rehabilitation

Dry needling

EXPERIMENTAL

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

Other: Dry needlingOther: Physical therapy and rehabilitation

Interventions

Dry needlingOTHER

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.

Dry needling
Physical therapy and rehabilitationOTHER

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.

Dry needlingPhysical therapy and rehabilitation

Eligibility Criteria

Age40 Years - 70 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylosis

Interventions

Dry NeedlingPhysical Therapy ModalitiesRehabilitation

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 16, 2023

First Posted

February 27, 2023

Study Start

February 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)