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

Sponsor
Uskudar University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06003907
Collaborator
(none)
50
1
2
2.5
20

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: conventional
  • Other: traditional and complementary medicine methods
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
conservative and traditional physiotherapyconservative and traditional physiotherapy
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Conservative Treatment and Graston and Cup Applications in Patients With Cervical Disc Herniation
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Oct 20, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. The Fremantle Neck Awareness Questionnaire [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)

  2. Berg Balance Scale [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.

  3. Jenkins Sleep Scale [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Üsküdar Unıversıty Üsküdar İstanbul Turkey

Sponsors and Collaborators

  • Uskudar University

Investigators

  • Study Chair: Beste İNCEKULAK, Uskudar University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Öğr. Üyesi Ömer Şevgin, Asst. Prof. Dr., Uskudar University
ClinicalTrials.gov Identifier:
NCT06003907
Other Study ID Numbers:
  • Uskudar65
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Öğr. Üyesi Ömer Şevgin, Asst. Prof. Dr., Uskudar University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2023