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

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.

Study Overview

• Status: Completed
• Conditions: Physical Therapy; Stretch; Electrotherapy; Cervical Flexibility
• Intervention / Treatment: Procedure: Traction; Procedure: Stretching; Procedure: Laser therapy; Procedure: Hot pack

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

-Healthy individuals without any cervical region pathology

Exclusion Criteria:

• Pregnancy and cancer
• Uncontrolled hypertension
• Presence of neurological symptoms
• Spinal surgery history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traction and stretching; This grup received stretching exercises after traction therapy for 18 sessions, 3 times per week.	Procedure: 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.; 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.
Experimental: Laser therapy and stretching; This grup received stretching exercises after laser therapy for 18 sessions, 3 times per week.	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.; 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.
Experimental: Hot pack and stretching; This grup received stretching exercises after hotpack therapy for 18 sessions, 3 times per week.	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.; 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.
Experimental: Stretching only; This grup received only stretching exercises for 18 sessions, 3 times per week.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical range of motion (ROM)	ROM is measured by CROM device during flexion, extension, right/left lateral flexion and right/left rotation activity.	Baseline to 6 weeks after
Cervical flexibility	Cervical flexibility is measured using the standard tape measure, the distance between the occiput and the wall in the standing position of the participants, and the distance between the earlobe and the acromion.	Baseline to 6 weeks after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervikal Muscle spasm	The degree of muscular spasm in the upper trapezoidal muscle, sternocleudomasteudeus (SCM) muscle, and scalen muscles is evaluated by palpation over 4 points.	Baseline to 6 weeks after

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical Performance Level	In cervical flexion, extension, right and left lateral flexion directions, cervical performance tests are evaluated by recording the holding time in the desired position with a stopwatch.	Baseline to 6 weeks after
Muscle Strength of Deep Cervical Flexor Muscles	Strength measurement of deep cervical flexor muscles is evaluated with the Stabilizer Pressure Biofeedback device (Chattanooga Medical Suplly Inc, Chattanooga, TN).	Baseline to 6 weeks after

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Study Chair: Şule ŞİMŞEK, PhD, Pamukkale University; Study Chair: Ummuhan BAŞ ASLAN, Prof. Dr., Pamukkale University; Study Chair: Merve BERGİN KORKMAZ, Dr., Denizli Devlet Hastanesi

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): August 18, 2022
• Study Completion (Actual): August 19, 2022

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): January 2, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: exercise; laser therapy; traction; hotpack
• Other Study ID Numbers: 2018KRM019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: there is no web site to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No