NCT04330313

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration 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

Study Start

First participant enrolled

September 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2022

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

2.9 years

First QC Date

March 27, 2020

Last Update Submit

December 29, 2023

Conditions

Keywords

exercisehotpacklaser therapytraction

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Cervikal Muscle spasm

    Baseline to 6 weeks after

Other Outcomes (2)

  • Cervical Performance Level

    Baseline to 6 weeks after

  • Muscle Strength of Deep Cervical Flexor Muscles

    Baseline to 6 weeks after

Study Arms (4)

Traction and stretching

EXPERIMENTAL

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

Procedure: TractionProcedure: Stretching

Laser therapy and stretching

EXPERIMENTAL

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

Procedure: Laser therapyProcedure: Stretching

Hot pack and stretching

EXPERIMENTAL

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

Procedure: Hot packProcedure: Stretching

Stretching only

EXPERIMENTAL

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

Procedure: Stretching

Interventions

TractionPROCEDURE

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.

Traction and stretching
Laser therapyPROCEDURE

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.

Laser therapy and stretching
Hot packPROCEDURE

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.

Hot pack and stretching
StretchingPROCEDURE

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 stretchingLaser therapy and stretchingStretching onlyTraction and stretching

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals without any cervical region pathology

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

Related 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.

    PMID: 20436238BACKGROUND
  • 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.

    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.

    PMID: 23114092BACKGROUND
  • 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.

    PMID: 29169335BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

TractionLaser Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, OperativeTherapeuticsAblation Techniques

Study Officials

  • Şule ŞİMŞEK, PhD

    Pamukkale University

    STUDY CHAIR
  • Ummuhan BAŞ ASLAN, Prof. Dr.

    Pamukkale University

    STUDY CHAIR
  • Merve BERGİN KORKMAZ, Dr.

    Denizli Devlet Hastanesi

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There are paralel groups, each has 15 participants. Different electrotherapy applications will be applied to each group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2020

First Posted

April 1, 2020

Study Start

September 30, 2019

Primary Completion

August 18, 2022

Study Completion

August 19, 2022

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

there is no web site to share data

Locations