Use of Different Electrophysical Agents in Cervical Region Flexibility Training of Healthy Individuals

NCT ID: NCT04330313

Last Updated: 2024-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2022-08-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

60 healthy participants with right / left upper trapezoidal shortness based on volunteering will be included in the study. Participants were randomly divided into 4 groups; Traction and stretching exercises to group 1 (n = 15), laser therapy and stretching exercise to group 2 (n = 15), hot pack and stretching exercises to group 3 (n = 15), and group 4 (control group) only stretching exercises will be applied.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Healthy individuals without any cervical region pathology will be included in the study. Exclusion criterias are pregnancy or cancer, hypertension that cannot be controlled, having neurological symptoms, previous spinal surgery.

Demographic information of the participants will be recorded; cervical joint range of motion (CROM device), muscle shortness (acromion-earlobe and occiput-wall distance measurement), deep cervical flexor muscle strength (Stabilizer Pressure Biofeedback), cervical performance level (Cervical Performance Tests), muscle spasm (Palpable Muscle Spasm Scoring) will be evaluated. Cervical joint range of motion and muscle shortening will be repeated before and after each session, but other parameters will only be repeated at the beginning and the end.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Flexibility Stretch Physical Therapy Electrotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are paralel groups, each has 15 participants. Different electrotherapy applications will be applied to each group.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Traction and stretching

This grup received stretching exercises after traction therapy for 18 sessions, 3 times per week.

Group Type EXPERIMENTAL

Traction

Intervention Type PROCEDURE

Intermittent traction will be applied to the cervical region in a supine position with the neck at 25-30 ° flexion. The target weight is determined as 10% of the patient's weight. Traction pulling force applied to the target weight will be achieved gradually increasing from low. Traction therapy will be applied intermittent traction for 15 minutes in each session as 60 seconds retention and 60 seconds rest. The therapy will be held for 18 sessions, 3 days / week.

Stretching

Intervention Type PROCEDURE

Stretching exercises will be repeated 3 times a day in total, 2 times a day self-stretching at home and 1 time under the supervision of a physiotherapist. Exercises for upper trapezius muscle, sternokleudomasteudeus (SCM) muscle and the scalene muscle to be applied in a 3 repeat by waiting 30 seconds, stretching under tension.The therapy will be held for 18 sessions, 3 days / week.

Laser therapy and stretching

This grup received stretching exercises after laser therapy for 18 sessions, 3 times per week.

Group Type EXPERIMENTAL

Laser therapy

Intervention Type PROCEDURE

Laser therapy will be applied to the participants with a GaAs laser with 904 nm wavelength, 6 points transforaminally, 120 seconds to each point, at 2 J / cm² density, total dose of 12 J laser therapy by keeping the probe in constant contact with the skin.

Stretching

Intervention Type PROCEDURE

Stretching exercises will be repeated 3 times a day in total, 2 times a day self-stretching at home and 1 time under the supervision of a physiotherapist. Exercises for upper trapezius muscle, sternokleudomasteudeus (SCM) muscle and the scalene muscle to be applied in a 3 repeat by waiting 30 seconds, stretching under tension.The therapy will be held for 18 sessions, 3 days / week.

Hot pack and stretching

This grup received stretching exercises after hotpack therapy for 18 sessions, 3 times per week.

Group Type EXPERIMENTAL

Hot pack

Intervention Type PROCEDURE

The hot pack, which is the superficial heat agent, will be held in the neck area of the participants for 20 minutes in each session.The therapy will be held for 18 sessions, 3 days / week.

Stretching

Intervention Type PROCEDURE

Stretching exercises will be repeated 3 times a day in total, 2 times a day self-stretching at home and 1 time under the supervision of a physiotherapist. Exercises for upper trapezius muscle, sternokleudomasteudeus (SCM) muscle and the scalene muscle to be applied in a 3 repeat by waiting 30 seconds, stretching under tension.The therapy will be held for 18 sessions, 3 days / week.

Stretching only

This grup received only stretching exercises for 18 sessions, 3 times per week.

Group Type EXPERIMENTAL

Stretching

Intervention Type PROCEDURE

Stretching exercises will be repeated 3 times a day in total, 2 times a day self-stretching at home and 1 time under the supervision of a physiotherapist. Exercises for upper trapezius muscle, sternokleudomasteudeus (SCM) muscle and the scalene muscle to be applied in a 3 repeat by waiting 30 seconds, stretching under tension.The therapy will be held for 18 sessions, 3 days / week.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Traction

Intermittent traction will be applied to the cervical region in a supine position with the neck at 25-30 ° flexion. The target weight is determined as 10% of the patient's weight. Traction pulling force applied to the target weight will be achieved gradually increasing from low. Traction therapy will be applied intermittent traction for 15 minutes in each session as 60 seconds retention and 60 seconds rest. The therapy will be held for 18 sessions, 3 days / week.

Intervention Type PROCEDURE

Laser therapy

Laser therapy will be applied to the participants with a GaAs laser with 904 nm wavelength, 6 points transforaminally, 120 seconds to each point, at 2 J / cm² density, total dose of 12 J laser therapy by keeping the probe in constant contact with the skin.

Intervention Type PROCEDURE

Hot pack

The hot pack, which is the superficial heat agent, will be held in the neck area of the participants for 20 minutes in each session.The therapy will be held for 18 sessions, 3 days / week.

Intervention Type PROCEDURE

Stretching

Stretching exercises will be repeated 3 times a day in total, 2 times a day self-stretching at home and 1 time under the supervision of a physiotherapist. Exercises for upper trapezius muscle, sternokleudomasteudeus (SCM) muscle and the scalene muscle to be applied in a 3 repeat by waiting 30 seconds, stretching under tension.The therapy will be held for 18 sessions, 3 days / week.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

-Healthy individuals without any cervical region pathology

Exclusion Criteria

* Pregnancy and cancer
* Uncontrolled hypertension
* Presence of neurological symptoms
* Spinal surgery history
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ATİYE KAŞ ÖZDEMİR

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Şule ŞİMŞEK, PhD

Role: STUDY_CHAIR

Pamukkale University

Ummuhan BAŞ ASLAN, Prof. Dr.

Role: STUDY_CHAIR

Pamukkale University

Merve BERGİN KORKMAZ, Dr.

Role: STUDY_CHAIR

Denizli Devlet Hastanesi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Audette I, Dumas JP, Cote JN, De Serres SJ. Validity and between-day reliability of the cervical range of motion (CROM) device. J Orthop Sports Phys Ther. 2010 May;40(5):318-23. doi: 10.2519/jospt.2010.3180.

Reference Type BACKGROUND
PMID: 20436238 (View on PubMed)

Hudswell, S., von Mengersen, M., Lucas, N. The cranio-cervical flexion test using pressure biofeedback: A useful measure of cervical dysfunction in the clinical setting? International Journal of Osteopathic Medicine. 2005; 8(3): 98-105.

Reference Type BACKGROUND

Shahidi B, Johnson CL, Curran-Everett D, Maluf KS. Reliability and group differences in quantitative cervicothoracic measures among individuals with and without chronic neck pain. BMC Musculoskelet Disord. 2012 Oct 31;13:215. doi: 10.1186/1471-2474-13-215.

Reference Type BACKGROUND
PMID: 23114092 (View on PubMed)

Zhang LL, Zhou GQ, Qi ZY, He XJ, Li JX, Tang LL, Mao YP, Lin AH, Ma J, Sun Y. Patient- and treatment-related risk factors associated with neck muscle spasm in nasopharyngeal carcinoma patients after intensity-modulated radiotherapy. BMC Cancer. 2017 Nov 23;17(1):788. doi: 10.1186/s12885-017-3780-9.

Reference Type BACKGROUND
PMID: 29169335 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018KRM019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effectiveness of NMES on Neck Pain
NCT06320340 COMPLETED NA