- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06003907
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
27
Phase
- 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 Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: conventional physiotherapy
traditional and complementary medicine methods will not be used.
|
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.
|
hot application electrotherapy ultrasound mobilization joint range of motion exercises stretching exercises balance exercises posture exercises
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
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
Investigators
- 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
- Kim S, Lee SH, Kim MR, Kim EJ, Hwang DS, Lee J, Shin JS, Ha IH, Lee YJ. Is cupping therapy effective in patients with neck pain? A systematic review and meta-analysis. BMJ Open. 2018 Nov 5;8(11):e021070. doi: 10.1136/bmjopen-2017-021070.
- Keramat KU, Gaughran A. Safe physiotherapy interventions in large cervical disc herniations. BMJ Case Rep. 2012 Aug 18;2012:bcr2012006864. doi: 10.1136/bcr-2012-006864.
- Crothers A, Walker B, French SD. Spinal manipulative therapy versus Graston Technique in the treatment of non-specific thoracic spine pain: design of a randomised controlled trial. Chiropr Osteopat. 2008 Oct 30;16:12. doi: 10.1186/1746-1340-16-12.
- Choi TY, Ang L, Ku B, Jun JH, Lee MS. Evidence Map of Cupping Therapy. J Clin Med. 2021 Apr 17;10(8):1750. doi: 10.3390/jcm10081750.
- Abdel-Aal NM, Elsayyad MM, Megahed AA. Short-term effect of adding Graston technique to exercise program in treatment of patients with cervicogenic headache: a single-blinded, randomized controlled trial. Eur J Phys Rehabil Med. 2021 Oct;57(5):758-766. doi: 10.23736/S1973-9087.21.06595-3. Epub 2021 May 5.
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)
September 1, 2023
Primary Completion (Actual)
December 20, 2023
Study Completion (Actual)
January 2, 2024
Study Registration Dates
First Submitted
August 15, 2023
First Submitted That Met QC Criteria
August 16, 2023
First Posted (Actual)
August 22, 2023
Study Record Updates
Last Update Posted (Actual)
October 18, 2024
Last Update Submitted That Met QC Criteria
October 16, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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