Cervical Disc HerniationNCT06526325
The Effect of Tendon Release Techniques in Patients With Cervical Disc Herniation
A study testing Enhanced golgi tendon organ stimulation in people with Cervical Disc Herniation, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to investigate the effect of using enhanced golgi tendon organ stimulation on symptoms in patients with cervical disc herniation. The main question[s] it aims to answer are: Enhanced Golgi tendon organ stimulation is effective in reducing symptoms in patients with cervical disc… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Disc Herniation
- What is being tested?
- Enhanced golgi tendon organ stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2024to 19 Aug 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with cervical disc herniation
- Volunteering for the research
Who cannot join
- Chronic bone disease
- Have had surgery for a cervical disc herniation
- Have a structural abnormality
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
AS Physiotherapy Services centre
Istanbul, 34000
hasan aslan, Msc, +905538073527, asfizyoterapi@gmail.com
About this study
Official title: The Effect of Improved Golgi Tendon Organ Stimulation From Tendon Relaxation Techniques on Pain, Range of Motion, Functionality, Endurance and Quality of Life in Patients With Cervical Disc Herniation
The goal of this clinical trial is to investigate the effect of using enhanced golgi tendon organ stimulation on symptoms in patients with cervical disc herniation. The main question[s] it aims to answer are:
- Enhanced Golgi tendon organ stimulation is effective in reducing symptoms in patients with cervical disc herniation.
- Enhanced golgi tendon organ stimulation is not effective in reducing symptoms in patients with cervical disc herniation.
Participants will receive enhanced golgi tendon organ stimulation to the Sternocleidomastoideus, platysma, longus colli, longus capitis, scalene, rhomboid major \& minor, levator scapulae and trapezius muscles for 3 weeks, 2 sessions per week for 45 minutes.
Read the detailed description
Participants diagnosed with cervical disc herniation will be included. Participants will receive 6 sessions of 45 minutes each, 2 sessions per week for 3 weeks. Sternocleidomastoideus, platysma, longus colli, longus capitis, scalene muscles, rhomboid major \& minor, levator scapulae and trapezius muscles and tendons of these muscles will be applied.
Two separate applications are performed with the stimulator and the algometer. After increasing the blood flow in the area for 30 seconds with the vibration of the stimulator up to the point of attachment of the tendon, a pressure of 0.5 kilograms is applied at an angle of 90 degrees at 0.5 cm intervals from the origin to the insertion of the muscle in the area with an algometer made of special steel. The aim of this treatment is to stabilise the contraction and relaxation mechanism by stimulating the Golgi tendon organ and to eliminate pain by relieving spasms.
- Conditions
- Cervical Disc Herniation
- Being tested
- Enhanced golgi tendon organ stimulation
- Keywords
- disc herniation, enhanced golgi tendon organ stimulation, pain, cervical
- Medical subject headings
- Intervertebral Disc Displacement, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced golgi tendon organ stimulationDevice
Enhanced Golgi Tendon Organ Stimulation is a method that can be used by physiotherapists and doctors. The Golgi tendon organ is the proprioceptors located in the tendon adjacent to the myotendinous junction. It is applied using two separate heads, the stimulator and the algometer. The sternocleidomastoideus, platysma, colli longus, capitis longus, scalene, rhomboid major and minor, levator scapulae and trapezius muscles and their tendons will be vibrated with a stimulator for 30 seconds, then 0.5 kilograms of pressure will be applied with an algometer from the origin to the insertion of the muscle in the region at 0.5 centimetre intervals at an angle of 90 degrees.
| Study group | Role | What they receive |
|---|---|---|
| Application of enhanced Golgi tendon organ stimulation to patients | Experimental | The effect of golgi tendon organ stimulation on the symptoms will be examined after applying the improved golgi tendon organ stimulation to patients diagnosed with cervical disc herniation and having pain, limitation of movement, spasm and tenderness in the neck region. Receives: Device: Enhanced golgi tendon organ stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment with algometer
The sternocleidomastoid, platysma, longus colli, longus capitis, scalene, rhomboid major and minor, levator scapulae and trapezius muscles and their tendons are compressed to 0.5 kg using an algometer. The patient's response is used to determine whether or not there is pain.
Measured: baseline, immediately after the 6 weeks intervention
SF-36 (short form-36)
The Short Form-36 (SF-36) is a self-assessment scale and analyses 8 dimensions of health including physical function, social function, role limitations (due to physical and emotional reasons), mental health, vitality (energy), pain and general perception of health with 36 items. In scoring the scale, each sub-dimension is given a score between 0 and 100 points, where 0 points indicate that the quality of life dimension is poor and 100 points indicate that it is good.
Measured: baseline, immediately after the 6 weeks intervention
Secondary outcomes (4)
visual analogue scale (VAS)
For pain intensity according to VAS, "no pain" is usually graded as 0 points and "worst imaginable pain" as 10 points (10 cm scale). The ranges for pain intensity are <3 mild pain, 3-6 moderate pain, >6 severe pain.
Measured: baseline, immediately after the 6 weeks intervention
assessment of joint range of motion
Range of motion of the cervical spine will be assessed with a goniometer.
Measured: baseline, immediately after the 6 weeks intervention
Spurling Test
With the patient in an upright sitting position, the clinician flexes and laterally flexes the patient's head and applies cranial to caudal compression. The test is considered positive if there is pain, numbness and tingling. A positive spurling test indicates that there may be a problem such as a possible nerve root compression in this area. If the test is negative, it is said that nerve root compression is less likely.
Measured: baseline, immediately after the 6 weeks intervention
Endurance Test
The patient performs flexion, extension, right lateral flexion, left lateral flexion, right rotation and left rotation. Meanwhile, the clinician maintains the position by applying the same force in the opposite direction of movement. A stopwatch is used to time the onset of pain. The longer the time, the better the outcome. A shorter time indicates a poor clinical prognosis.
Measured: baseline, immediately after the 6 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start19 Feb 2024
- Primary completionAug 2024 (estimated)
- Study completion19 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cervical Disc HerniationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Aslan, Istanbul Arel University
- Investigators
- hasan aslan, Principal investigator, AS Physiotherapy Services centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526325
- Sponsor's protocol ID
- 2024/03
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yilmaz M, Tarakci D, Tarakci E. Comparison of high-intensity laser therapy and combination of ultrasound treatment and transcutaneous nerve stimulation on cervical pain associated with cervical disc herniation: A randomized trial. Complement Ther Med. 2020 Mar;49:102295. doi: 10.1016/j.ctim.2019.102295. Epub 2020 Jan 3.
PubMed 32147037Yang X, Arts MP, Bartels RHMA, Vleggeert-Lankamp CLA. The type of cervical disc herniation on MRI does not correlate to clinical outcomes. Bone Joint J. 2022 Nov;104-B(11):1242-1248. doi: 10.1302/0301-620X.104B11.BJJ-2022-0657.R2.
PubMed 36317351
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Improved Golgi Tendon Organ Stimulation From Tendon Relaxation Techniques on Pain, Range of Motion, Functionality, Endurance and Quality of Life in Patients With Cervical Disc Herniation
- ClinicalTrials.gov ID
- NCT06526325
- Acronym / sponsor ID
- 2024/03
- Conditions
- Cervical Disc Herniation
- Keywords
- disc herniation, enhanced golgi tendon organ stimulation, pain, cervical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- 19 Aug 2024 (estimated)
- First posted
- 29 Jul 2024 (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.
The goal of this clinical trial is to investigate the effect of using enhanced golgi tendon organ stimulation on symptoms in patients with cervical disc herniation. The main question[s] it aims to answer are:
- Enhanced Golgi tendon organ stimulation is effective in reducing symptoms in patients with cervical disc herniation.
- Enhanced golgi tendon organ stimulation is not effective in reducing symptoms in patients with cervical disc herniation.
Participants will receive enhanced golgi tendon organ stimulation to the Sternocleidomastoideus, platysma, longus colli, longus capitis, scalene, rhomboid major \& minor, levator scapulae and trapezius muscles for 3 weeks, 2 sessions per week for 45 minutes.
Detailed description
Participants diagnosed with cervical disc herniation will be included. Participants will receive 6 sessions of 45 minutes each, 2 sessions per week for 3 weeks. Sternocleidomastoideus, platysma, longus colli, longus capitis, scalene muscles, rhomboid major \& minor, levator scapulae and trapezius muscles and tendons of these muscles will be applied.
Two separate applications are performed with the stimulator and the algometer. After increasing the blood flow in the area for 30 seconds with the vibration of the stimulator up to the point of attachment of the tendon, a pressure of 0.5 kilograms is applied at an angle of 90 degrees at 0.5 cm intervals from the origin to the insertion of the muscle in the area with an algometer made of special steel. The aim of this treatment is to stabilise the contraction and relaxation mechanism by stimulating the Golgi tendon organ and to eliminate pain by relieving spasms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Application of enhanced Golgi tendon organ stimulation to patients | Experimental | Device: Enhanced golgi tendon organ stimulationThe effect of golgi tendon organ stimulation on the symptoms will be examined after applying the improved golgi tendon organ stimulation to patients diagnosed with cervical disc herniation and having pain, limitation of movement, spasm and tenderness in the neck region. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being diagnosed with cervical disc herniation
- Volunteering for the research
Key exclusion criteria (3 listed)
- Chronic bone disease
- Have had surgery for a cervical disc herniation
- Have a structural abnormality
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 |
|---|---|---|
| Enhanced golgi tendon organ stimulationEnhanced Golgi Tendon Organ Stimulation is a method that can be used by physiotherapists and doctors. The Golgi tendon organ is the proprioceptors located in the tendon adjacent to the myotendinous junction. It is applied using two separate heads, the stimulator and the algometer. The sternocleidomastoideus, platysma, colli longus, capitis longus, scalene, rhomboid major and minor, levator scapulae and trapezius muscles and their tendons will be vibrated with a stimulator for 30 seconds, then 0.5 kilograms of pressure will be applied with an algometer from the origin to the insertion of the muscle in the region at 0.5 centimetre intervals at an angle of 90 degrees. | Device | Application of enhanced Golgi tendon organ stimulation to patients |
Primary outcome
Pain assessment with algometer
Time frame: baseline, immediately after the 6 weeks intervention
The sternocleidomastoid, platysma, longus colli, longus capitis, scalene, rhomboid major and minor, levator scapulae and trapezius muscles and their tendons are compressed to 0.5 kg using an algometer. The patient's response is used to determine whether or not there is pain.
SF-36 (short form-36)
Time frame: baseline, immediately after the 6 weeks intervention
The Short Form-36 (SF-36) is a self-assessment scale and analyses 8 dimensions of health including physical function, social function, role limitations (due to physical and emotional reasons), mental health, vitality (energy), pain and general perception of health with 36 items. In scoring the scale, each sub-dimension is given a score between 0 and 100 points, where 0 points indicate that the quality of life dimension is poor and 100 points indicate that it is good.
4 secondary outcomes
visual analogue scale (VAS)
Time frame: baseline, immediately after the 6 weeks intervention
assessment of joint range of motion
Time frame: baseline, immediately after the 6 weeks intervention
Spurling Test
Time frame: baseline, immediately after the 6 weeks intervention
Endurance Test
Time frame: baseline, immediately after the 6 weeks intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Background: PubMed 32147037Yilmaz M, Tarakci D, Tarakci E. Comparison of high-intensity laser therapy and combination of ultrasound treatment and transcutaneous nerve stimulation on cervical pain associated with cervical disc herniation: A randomized trial. Complement Ther Med. 2020 Mar;49:102295. doi: 10.1016/j.ctim.2019.102295. Epub 2020 Jan 3.
- Background: PubMed 36317351Yang X, Arts MP, Bartels RHMA, Vleggeert-Lankamp CLA. The type of cervical disc herniation on MRI does not correlate to clinical outcomes. Bone Joint J. 2022 Nov;104-B(11):1242-1248. doi: 10.1302/0301-620X.104B11.BJJ-2022-0657.R2.
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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.
hasan aslan principal investigator
AS Physiotherapy Services centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced golgi tendon organ stimulation in people with Cervical Disc Herniation, run by Istanbul Arel 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hasan aslan (+905538073527, asfizyoterapi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment with algometer (time frame: baseline, immediately after the 6 weeks intervention). 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 NCT06526325, which also lists 2 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 31 Jul 2024.