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

Primary Purpose

Neck Pain, Cervical Disc Herniation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
conventional
traditional and complementary medicine methods
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring graston technique, cupping therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Üsküdar UnıversıtyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional physiotherapy

cupping therapy and graston

Arm Description

traditional and complementary medicine methods will not be used.

Complementary methods will be used alongside conventional physiotherapy.

Outcomes

Primary Outcome Measures

The Fremantle Neck Awareness Questionnaire
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)
Berg Balance Scale
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.
Jenkins Sleep Scale
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)

Secondary Outcome Measures

Full Information

First Posted
August 15, 2023
Last Updated
September 1, 2023
Sponsor
Uskudar University
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1. Study Identification

Unique Protocol Identification Number
NCT06003907
Brief Title
Comparison of Conservative Treatment and Graston and Cup Applications in Patients With Cervical Disc Herniation
Official Title
Comparison of Conservative Treatment and Graston and Cup Applications in Patients With Cervical Disc Herniation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
October 20, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The research will be carried out on 50 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Cervical Disc Herniation
Keywords
graston technique, cupping therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
conservative and traditional physiotherapy
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional physiotherapy
Arm Type
Active Comparator
Arm Description
traditional and complementary medicine methods will not be used.
Arm Title
cupping therapy and graston
Arm Type
Experimental
Arm Description
Complementary methods will be used alongside conventional physiotherapy.
Intervention Type
Other
Intervention Name(s)
conventional
Intervention Description
hot application electrotherapy ultrasound mobilization joint range of motion exercises stretching exercises balance exercises posture exercises
Intervention Type
Other
Intervention Name(s)
traditional and complementary medicine methods
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Fremantle Neck Awareness Questionnaire
Description
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)
Time Frame
6 weeks
Title
Berg Balance Scale
Description
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.
Time Frame
6 weeks
Title
Jenkins Sleep Scale
Description
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)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ömer ŞEVGİN
Phone
+905069787535
Email
omer.sevgin@uskudar.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beste İNCEKULAK
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
Facility Information:
Facility Name
Üsküdar Unıversıty
City
Üsküdar
State/Province
İstanbul
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22907861
Citation
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.
Results Reference
background
PubMed Identifier
18959807
Citation
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.
Results Reference
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PubMed Identifier
33920643
Citation
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.
Results Reference
background
PubMed Identifier
30397006
Citation
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.
Results Reference
background
PubMed Identifier
33947825
Citation
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.
Results Reference
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Comparison of Conservative Treatment and Graston and Cup Applications in Patients With Cervical Disc Herniation

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