Cervical FlexibilityNCT04330313
Use of Different Electrophysical Agents in Cervical Region Flexibility Training of Healthy Individuals
A study testing Traction, Laser therapy and Hot pack in people with Cervical Flexibility and Stretch, run by Pamukkale University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Flexibility, Stretch, Physical Therapy
- What is being tested?
- Traction, Laser therapy and Hot pack
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2019to 19 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Healthy individuals without any cervical region pathology
Who cannot join
- Pregnancy and cancer
- Uncontrolled hypertension
- Presence of neurological symptoms
- Spinal surgery history
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cervical Flexibility, Stretch, Physical Therapy, Electrotherapy
- Being tested
- Traction, Laser therapy, Hot pack, Stretching
- Keywords
- exercise, hotpack, laser therapy, traction
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TractionProcedure or surgery
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 therapyProcedure or surgery
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 packProcedure or surgery
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.
StretchingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Traction and stretching | Experimental | This grup received stretching exercises after traction therapy for 18 sessions, 3 times per week. Receives: Procedure: Traction; Procedure: Stretching |
| Laser therapy and stretching | Experimental | This grup received stretching exercises after laser therapy for 18 sessions, 3 times per week. Receives: Procedure: Laser therapy; Procedure: Stretching |
| Hot pack and stretching | Experimental | This grup received stretching exercises after hotpack therapy for 18 sessions, 3 times per week. Receives: Procedure: Hot pack; Procedure: Stretching |
| Stretching only | Experimental | This grup received only stretching exercises for 18 sessions, 3 times per week. Receives: Procedure: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical range of motion (ROM)
ROM is measured by CROM device during flexion, extension, right/left lateral flexion and right/left rotation activity.
Measured: 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.
Measured: Baseline to 6 weeks after
Secondary outcomes (1)
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.
Measured: Baseline to 6 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start30 Sep 2019
- Primary completion18 Aug 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical FlexibilityStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are paralel groups, each has 15 participants. Different electrotherapy applications will be applied to each group.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ATİYE KAŞ ÖZDEMİR, Pamukkale University
- Investigators
- Şule ŞİMŞEK, PhD, Study chair, Pamukkale UniversityUmmuhan BAŞ ASLAN, Prof. Dr., Study chair, Pamukkale UniversityMerve BERGİN KORKMAZ, Dr., Study chair, Denizli Devlet Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330313
- Sponsor's protocol ID
- 2018KRM019
- Status last verified
- Dec 2023
- First submitted
- 27 Mar 2020
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is no web site to share data
Publications
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.
PubMed 20436238Hudswell, 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.
PubMed 23114092Zhang 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.
PubMed 29169335
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Different Electrophysical Agents in Cervical Region Flexibility Training of Healthy Individuals
- ClinicalTrials.gov ID
- NCT04330313
- Acronym / sponsor ID
- 2018KRM019
- Conditions
- Cervical Flexibility, Stretch, Physical Therapy, Electrotherapy
- Keywords
- exercise, hotpack, laser therapy, traction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- There are paralel groups, each has 15 participants. Different electrotherapy applications will be applied to each group.
| Arm | Type | Receives |
|---|---|---|
| Traction and stretching | Experimental | Procedure: Traction, Procedure: StretchingThis grup received stretching exercises after traction therapy for 18 sessions, 3 times per week. |
| Laser therapy and stretching | Experimental | Procedure: Laser therapy, Procedure: StretchingThis grup received stretching exercises after laser therapy for 18 sessions, 3 times per week. |
| Hot pack and stretching | Experimental | Procedure: Hot pack, Procedure: StretchingThis grup received stretching exercises after hotpack therapy for 18 sessions, 3 times per week. |
| Stretching only | Experimental | Procedure: StretchingThis grup received only stretching exercises for 18 sessions, 3 times per week. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Healthy individuals without any cervical region pathology
Key exclusion criteria (4 listed)
- Pregnancy and cancer
- Uncontrolled hypertension
- Presence of neurological symptoms
- Spinal surgery history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TractionIntermittent 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 or surgery | Traction and stretching |
| Laser therapyLaser 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. | Procedure or surgery | Laser therapy and stretching |
| Hot packThe 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. | Procedure or surgery | Hot pack and stretching |
| StretchingStretching 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 or surgery | Hot pack and stretching, Laser therapy and stretching, Stretching only, Traction and stretching |
Primary outcome
Cervical range of motion (ROM)
Time frame: Baseline to 6 weeks after
ROM is measured by CROM device during flexion, extension, right/left lateral flexion and right/left rotation activity.
Cervical flexibility
Time frame: Baseline to 6 weeks after
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.
1 secondary outcome
Cervikal Muscle spasm
Time frame: Baseline to 6 weeks after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Background: PubMed 20436238Audette 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.
- BackgroundHudswell, 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: PubMed 23114092Shahidi 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.
- Background: PubMed 29169335Zhang 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.
- Individual participant dataSharing planned: No. there is no web site to share data
Related trials for Cervical Flexibility
Recruiting
High Intensity Laser Therapy (HILT) on Myofascial Trigger Points.
Myofascial Trigger Point Pain (MTrP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şule ŞİMŞEK, PhD study chair
Pamukkale University
Ummuhan BAŞ ASLAN, Prof. Dr. study chair
Pamukkale University
Merve BERGİN KORKMAZ, Dr. study chair
Denizli Devlet Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traction, Laser therapy and Hot pack in people with Cervical Flexibility and Stretch, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical range of motion (ROM) (time frame: Baseline to 6 weeks after). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04330313, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.