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Immediate Effect of Cervical Manual Therapy Methods in Patients With Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual therapy
myofascial release
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring manuel therapy, neck

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Neck pain
  • Being between 20-60 years old

Exclusion Criteria:

  • 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

Sites / Locations

  • Medipol hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual therapy

myofascial release

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Scoliometer
Bending the patient forward about 45 degrees is the angle at which the rotational deformity in the back region is best seen. The evaluation is completed by reading the degree of rotation of the curvature on the scoliometer according to the level where the curvature is highest.

Full Information

First Posted
October 3, 2022
Last Updated
January 2, 2023
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05567302
Brief Title
Immediate Effect of Cervical Manual Therapy Methods in Patients With Neck Pain
Official Title
Immediate Effect of Cervical Manual Therapy Methods in Patients With Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
October 8, 2022 (Actual)
Study Completion Date
January 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Therapeutic approaches are frequently used to reduce inflammation and accelerate the healing process. Reducing pain in neck diseases, ensuring sufficient length of the muscle, strength balance, improving strength and function, improving postural re-education and cervical movements are the main goals. With the increasing prevalence of neck pain, the search for new treatment methods is increasing. It includes manual therapy, manipulation, acupuncture, and soft tissue therapy for chronic neck pain. Neck pain results from deep muscle dysfunctions and altered fascia structures. In this case, it may cause the disruption of the continuous musculofacial corset-like system. In addition, changes in the fascia (increased fascial thickness and disruption of fascial alignment) may affect this system more. Myofascial release is one of the soft tissue treatment applications. Although there are studies reporting that myofascial release is a method that can achieve positive effects such as reducing pain intensity and improving muscle function, there are few studies on this subject in the literature and sufficient evidence has not been reached.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
manuel therapy, neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Evaluation and treatment will be carried out by different physiotherapists. In this way, it is aimed to provide an objective evaluation
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
myofascial release
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
myofascial release
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
one day
Title
pinchmeter
Description
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.
Time Frame
one day
Title
Jamar Hand Dynomometer
Description
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.
Time Frame
one day
Secondary Outcome Measure Information:
Title
Scoliometer
Description
Bending the patient forward about 45 degrees is the angle at which the rotational deformity in the back region is best seen. The evaluation is completed by reading the degree of rotation of the curvature on the scoliometer according to the level where the curvature is highest.
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Neck pain Being between 20-60 years old Exclusion Criteria: 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
Facility Information:
Facility Name
Medipol hospital
City
Istanbul
State/Province
Istanbul Avrupa Kitasi
ZIP/Postal Code
34353
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33090945
Citation
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.
Results Reference
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Immediate Effect of Cervical Manual Therapy Methods in Patients With Neck Pain

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