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NCT Number: NCT06526325

The Effect of Tendon Release Techniques 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AS Physiotherapy Services centre

Istanbul, 34000, Turkey (Türkiye)

Location status: Recruiting

Location contact

hasan aslan, Msc

CONTACT

[email protected]

+905538073527

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Enhanced golgi tendon organ stimulation

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. visual analogue scale (VAS)

    Time frame: baseline, immediately after the 6 weeks intervention

    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.

  2. assessment of joint range of motion

    Time frame: baseline, immediately after the 6 weeks intervention

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

  3. Spurling Test

    Time frame: baseline, immediately after the 6 weeks intervention

    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.

  4. Endurance Test

    Time frame: baseline, immediately after the 6 weeks intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

hasan aslan

CONTACT

[email protected]

+905538073527

mehmet aslan

CONTACT

[email protected]

+905521873527

Sponsors and collaborators

Lead sponsor

Istanbul Arel University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 29, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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