NCT05851703

Brief Summary

The location of neck pain is usually shown as "pain occurring between the occiput and the third thoracic vertebra". The annual incidence of mechanical neck pain is 12/1000 patients and is one of the most common reasons for visiting physicians. Neck pain usually lasts longer than 3 months and results in a high cost to society

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

May 16, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

Same day

First QC Date

April 30, 2023

Last Update Submit

May 12, 2024

Conditions

Keywords

pain

Outcome Measures

Primary Outcomes (5)

  • Neck Disability Index

    The Neck Disability Index (NDI) measures acute and chronic neck pain or disability due to neck injury. It is the most common assessment tool used in the neck. It consists of 10 items. These; intensity of pain, personal care, lifting, reading, headaches, concentration, work, driving, sleep and leisure activities. There are 6 options in each item and the patient will mark one of these options and be evaluated accordingly.

    one day

  • Visual Analogue Scale

    In the measurement of neck pain severity, it was planned to use a standard, proven 10 mm VAS. The severity of pain felt by the patient; It is a scale used to mark 0 = no pain and 10 = the most severe pain, thus determining the patient's pain intensity subjectively.

    one day

  • Algometer

    It can be used to measure the sensitivity of tissues. The pressure is gradually increased and people must report the feeling of pressure applied. It has been shown that pressure algometry is a highly valid and reliable measurement of cranio-cervical muscles.

    one day

  • Pinchmeter

    It will be used to assess finger grip strengths. Measurements will be evaluated on both hands. Before the measurements, the participants will be informed verbally and they will be allowed to experiment. When the participants are ready, they are asked to squeeze the dynamometer with all their strength for 3 seconds and then release it. Participants will rest for 1 minute between measurements.

    one day

  • Jamar Hand Dynomometer

    The patients were placed in the sitting position with the wrist in 90° flexion and the forearm in the neutral position. Before the measurements, the participants will be informed verbally. Participants will then be asked to squeeze with all their strength for 3 seconds and then release. Participants will rest for 1 minute between measurements

    one day

Study Arms (2)

Manual therapy applications:

EXPERIMENTAL

In lower cervical lateral flexion problems, pushing technique will be applied with instrument support from the articular pillar part of the superior vertebra on the side where the limitation is present

Other: Manual therapy application

Proprioceptive Neuromuscular Facilitation

EXPERIMENTAL

Proprioceptive Neuromuscular Facilitation (PNF) techniques will be applied to the second group.

Other: Proprioceptive Neuromuscular Facilitation

Interventions

In lower cervical lateral flexion problems, pushing technique will be applied with instrument support from the articular pillar part of the superior vertebra on the side where the limitation is present. In lower cervical lateral flexion problems, instrument-assisted pushing technique will be applied from the articular pillar part of the superior vertebra on the side where the limitation is present.

Manual therapy applications:

With the rhythmic initiation technique, it is to teach the movement to the person, to improve the feeling of movement, coordination and to help relaxation. With rhythmic initiation, we want the patient's initial passive and then active participation to understand the movement, the direction and rhythm of the movement. After people actively participate, they can use active joint movement.

Proprioceptive Neuromuscular Facilitation

Eligibility Criteria

Age18 Months - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Those with neck pain
  • Being between 20-60 years old

You may not qualify if:

  • High blood pressure
  • Cardiopulmonary disease
  • Malignant
  • Operation, injection, etc. for the neck in the last 3 months. those with a history of treatment
  • Spine surgery
  • Psychological disturbance
  • Neurological and orthopedic deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ismet Yurtdsever

Istanbul, None Selected, 34353, Turkey (Türkiye)

Location

Related Publications (1)

  • Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.

    PMID: 28826164BACKGROUND

MeSH Terms

Conditions

Neck PainPain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2023

First Posted

May 10, 2023

Study Start

May 16, 2023

Primary Completion

May 16, 2023

Study Completion

April 26, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations