NCT06526325

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 19, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 3, 2024

Last Update Submit

July 29, 2024

Conditions

Keywords

disc herniationenhanced golgi tendon organ stimulationpaincervical

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    baseline, immediately after the 6 weeks intervention

Secondary Outcomes (4)

  • visual analogue scale (VAS)

    baseline, immediately after the 6 weeks intervention

  • assessment of joint range of motion

    baseline, immediately after the 6 weeks intervention

  • Spurling Test

    baseline, immediately after the 6 weeks intervention

  • Endurance Test

    baseline, immediately after the 6 weeks intervention

Study Arms (1)

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.

Device: Enhanced golgi tendon organ stimulation

Interventions

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.

Application of enhanced Golgi tendon organ stimulation to patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AS Physiotherapy Services centre

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32147037BACKGROUND
  • 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.

    PMID: 36317351BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc DisplacementPain

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • hasan aslan

    AS Physiotherapy Services centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 3, 2024

First Posted

July 29, 2024

Study Start

February 19, 2024

Primary Completion

August 1, 2024

Study Completion

August 19, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations