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

Physical Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04330313
• Other study ID #: 2018KRM019
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: August 19, 2022

Study information

• Verified date: December 2023
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 19, 2022
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

-Healthy individuals without any cervical region pathology

Exclusion Criteria:

• Pregnancy and cancer

• Uncontrolled hypertension

• Presence of neurological symptoms

• Spinal surgery history

Related Conditions & MeSH terms

• Cervical Flexibility
• Electrotherapy
• Physical Therapy
• Stretch

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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.

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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