NCT05567302

Brief Summary

Chronic neck pain is an important health problem in modern society and is frequently encountered today. Approximately 10% of the adult population experiences neck pain at least once in their lives. Anamnesis of the patient with neck pain; It should include the patient's complaints, illness history, family history, social status, work life and leisure activities. The age of the patient, the severity of the symptoms, the mechanism of the injury, the activity history, the duration of the symptoms, the location and limits, the spread of the pain, the relationship of the complaints with the change in position, the restrictions during movement, and the sleeping positions should be taken into account. In addition, past diseases, operations and current diseases, medications used should be recorded. Among chronic pains, neck pain ranks second after low back pain. Physical stresses in daily living activities, maintaining static posture and sleeping habits, carrying bags and weights in the wrong position, muscle imbalance are important factors in neck pain. Although cervical spine involvements have a great effect on neck pain, almost all of them have paravertebral muscle spasm, especially trapezius muscle spasm. Physiotherapy applications are widely used in the treatment of chronic neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

October 7, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2023

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

1 day

First QC Date

October 3, 2022

Last Update Submit

January 2, 2023

Conditions

Keywords

manuel therapyneck

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale (VAS)

    In the measurement of neck pain severity, a standard, proven reliability 10 mm VAS will be used. A value between 0 and 10 will be determined for the VAS, with 0 in the absence of pain and 10 mm in the most severe pain.

    one day

  • pinchmeter

    Finger grip strength is evaluated with a pinchmeter in both hands. Prior to measurements, participants will be verbally informed and 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. The same process is repeated in the same way after the application and the values are noted.

    one day

  • Jamar Hand Dynomometer

    The grip strengths of all participants were in the standard position recommended by the "American Society of Hand Therapist" on both hands; Hand dynamometer is evaluated with elbow in 90° flexion, forearm and wrist in neutral position. When participants are ready, they will be asked to squeeze the dynamometer with all their strength for 3 seconds and then release it. Rest for 1 minute between measurements. The evaluation will be taken three times and the averages will be recorded as a result of the measurement. The same process is repeated in the same way after the application and the values are noted.

    one day

Secondary Outcomes (1)

  • Scoliometer

    one day

Study Arms (2)

Manual therapy

EXPERIMENTAL

Manual therapy, manipulative therapy, is a completely manual treatment method that includes special techniques and is known as a treatment that aims to correct bony deformities and is highly effective when combined with exercise.

Other: Manual therapy

myofascial release

ACTIVE COMPARATOR

Foam rollers are a popular tool for helping athletes release muscle knots or trigger points.Myofascial release is a soft tissue method that provides removal of adhesions and tissue tension in tissues due to overload and repetitive use.

Other: myofascial release

Interventions

In lower cervical lateral flexion problems, manipulative correction technique will be applied from the articular pillar part of the superior vertebra on the side where the limitation is present. In lower cervical lateral flexion problems, manipulative correction technique will be applied from the articular pillar part of the superior vertebra on the side where the limitation is present. A rotational maneuver will be performed from the posterior side of the articular pillar part of the superior vertebra, on the opposite side of the side where the movement restriction is present.

Manual therapy

The soft tissue is palpated by the physiotherapist and pressure is applied directly to the skin until the tissue barrier is felt in the direction of restriction. Once the tissue barrier is present, it is applied for 90-120 seconds, without slipping on the skin or forcing the tissue, until the fascia complex begins to loosen and a softening sensation is achieved.

myofascial release

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Neck pain
  • Being between 20-60 years old

You may not qualify if:

  • Cardiopulmonary disease
  • malignancy and pregnancy
  • Operation, injection, etc. for the neck in the last 3 months. those with a history of treatment
  • Spine surgery
  • Psychological discomfort
  • Neurological and orthopedic deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol hospital

Istanbul, Istanbul Avrupa Kitasi, 34353, Turkey (Türkiye)

Location

Related Publications (1)

  • Ghan GM, Babu VS. Immediate Effect of Cervico-thoracic Mobilization on Deep Neck Flexors Strength in Individuals with Forward Head Posture: A Randomized Controlled Trial. J Man Manip Ther. 2021 Jun;29(3):147-157. doi: 10.1080/10669817.2020.1834321. Epub 2020 Oct 22.

    PMID: 33090945BACKGROUND

MeSH Terms

Conditions

Neck Pain

Interventions

Musculoskeletal ManipulationsMyofascial Release Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMassageTherapy, Soft Tissue

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Evaluation and treatment will be carried out by different physiotherapists. In this way, it is aimed to provide an objective evaluation
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 5, 2022

Study Start

October 7, 2022

Primary Completion

October 8, 2022

Study Completion

January 2, 2023

Last Updated

January 4, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations