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RecruitingNCT06526325Updated Jul 31, 2024

The Effect of Tendon Release Techniques in Patients With Cervical Disc Herniation

An interventional study of Enhanced golgi tendon organ stimulation in Cervical Disc Herniation, sponsored by Istanbul Arel University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Istanbul Arel University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled Feb 2024, registered Jul 2024).
  • Started Feb 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cervical Disc Herniation

Keywords

  • disc herniation
  • enhanced golgi tendon organ stimulation
  • pain
  • cervical
03

In context

Intervertebral Disc Displacement

478 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.

This study's planned enrollment of 51 is below the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.

Browse Intervertebral Disc Displacement studies →

Lead sponsor

Istanbul Arel University is the lead sponsor of 44 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Being diagnosed with cervical disc herniation
  • Volunteering for the research

Exclusion criteria

Exclusion Criteria:

  • Chronic bone disease
  • Have had surgery for a cervical disc herniation
  • Have a structural abnormality
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (estimated)

Study arms

  • Experimental
    Application of enhanced Golgi tendon organ stimulation to patients

    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.

    Device: Enhanced golgi tendon organ stimulation

Interventions

  • DeviceEnhanced golgi tendon organ stimulation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline, immediately after the 6 weeks intervention

  2. 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.

    Time frame: baseline, immediately after the 6 weeks intervention

Secondary outcomes

  1. 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.

    Time frame: baseline, immediately after the 6 weeks intervention

  2. assessment of joint range of motion

    Range of motion of the cervical spine will be assessed with a goniometer.

    Time frame: baseline, immediately after the 6 weeks intervention

  3. 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.

    Time frame: baseline, immediately after the 6 weeks intervention

  4. 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.

    Time frame: baseline, immediately after the 6 weeks intervention

07

Study locations

1 of 1 sites recruiting
  • AS Physiotherapy Services centre
    Istanbul, 34000, Turkey
    Recruiting
08

References and documents

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 32147037 ↗
  • Yang 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06526325
Lead sponsor
Istanbul Arel University
Responsible party
Hasan Aslan (Principal Investigator, Istanbul Arel University) — Principal investigator
First posted
Jul 29, 2024
Start date
Feb 19, 2024
Primary completion
Aug 2024 (estimated)
Completion
Aug 19, 2024 (estimated)
Last update
Jul 31, 2024

Study contacts

hasan aslan
Contact
asfizyoterapi@gmail.com
+905538073527
mehmet aslan
Contact
sharisin.aslan@gmail.com
+905521873527
hasan aslan
principal investigator · AS Physiotherapy Services centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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