Comparison of Conservative Treatment and Graston and Cup Applications in Patients With Cervical Disc Herniation

October 16, 2024 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University

Effectiveness of Graston and Cupping Applications in Individuals With Cervical Disc Herniation: A Randomized Controlled Trial

The aim of the study is to examine the effects of graston and dry cupping techniques applied in addition to the conservative treatment program on neck awareness, grip strength, balance and sleep quality in patients with cervical disc herniation between the ages of 18-65.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The research will be carried out on 30 cases diagnosed with cervical disc herniation between the ages of 18-65. The patients will be divided into 2 groups as control and experimental groups by simple randomization method. While the conservative physical therapy program is applied to the control group, the patients in the experimental group will be applied 1 day graston and 1 day dry cup technique in addition to the ones in the experimental group. All patients will be treated for 20 sessions, 5 days / 4 weeks. Fremantle Neck Awareness Questionnaire to assess neck awareness, hand dynamometer to assess grip strength, Berg Balance Scale to assess balance and Jenkins Sleep Scale to assess sleep quality will be used. All tests will be measured at the start of treatment and after 4 weeks of intervention. Pre- and post-intervention data were statistically analyzed and compared.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • İstanbul
      • Üsküdar, İstanbul, Turkey
        • Üsküdar Unıversıty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between the ages of 18-65
  • Being diagnosed with cervical disc herniation
  • Being diagnosed with cervical disc herniation at the level of bulging or protrusion according to MRI results

Exclusion Criteria:

  • Presence of cervical spine surgery history
  • Presence of primary or spinal metastatic malignancy
  • Having vascular problems
  • Individuals with sleep apnea
  • Those who use psychiatric drugs
  • Presence of various pathologies in the upper extremity (fracture, ganglion cyst, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: conventional physiotherapy
traditional and complementary medicine methods will not be used.
Other: conventional
hot application electrotherapy ultrasound mobilization joint range of motion exercises stretching exercises balance exercises posture exercises
Experimental: cupping therapy and graston
Complementary methods will be used alongside conventional physiotherapy.
Other: conventional
hot application electrotherapy ultrasound mobilization joint range of motion exercises stretching exercises balance exercises posture exercises
Other: traditional and complementary medicine methods

The Graston Technique is a form of manual therapy known as instrument assisted soft tissue mobilization. Graston massage is performed using titanium-coated metal rods specially designed for different parts of the body.

Cupping therapy is a treatment method that creates a regional vacuum to increase the blood circulation of the person and provide healing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Fremantle Neck Awareness Questionnaire
Time Frame: 6 weeks
It is a 9-question questionnaire that evaluates the way people perceive the communication between their neck and their body, and the way they perceive their body position. Evaluates the perception that differs according to the individual. It is a Likert-type questionnaire (0 = Never/Never feel this way, 1= I rarely feel this way, 2 = Sometimes, or sometimes I feel this way, 3 = I feel this way often, 4 = I feel this way all or most of the time)
6 weeks
Berg Balance Scale
Time Frame: 6 weeks
The Berg Balance Scale is a scale developed for the assessment of postural control in adults and is easily used in many areas of rehabilitation. It consists of 14 items in total. Scoring evaluates whether the patient can safely perform a task in a given amount of time. High fall risk and balance disorder between 0-20 points; A score of 21-40 indicates moderate risk of falling and an acceptable balance; A score of 41 and above indicates good balance and minimal risk of falling.
6 weeks
Jenkins Sleep Scale
Time Frame: 6 weeks
The Jenkins Sleep Scale is used in clinical studies to evaluate the sleep problems of patients. Patients are asked 4 questions about sleep problems in the last month and are asked to answer them. 0 (hardly), 1 (1-3 days per month), 2 (4-7 days per month), 3 (8-14 days per month), 4 (15-21 days per month), 5 (23-31 days per month)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uskudar University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Beste İNCEKULAK, Uskudar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Uskudar65

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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