NCT06003907

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2024

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

August 15, 2023

Last Update Submit

October 16, 2024

Conditions

Keywords

graston techniquecupping therapy

Outcome Measures

Primary Outcomes (3)

  • 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)

    6 weeks

  • 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.

    6 weeks

  • 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)

    6 weeks

Study Arms (2)

conventional physiotherapy

ACTIVE COMPARATOR

traditional and complementary medicine methods will not be used.

Other: conventional

cupping therapy and graston

EXPERIMENTAL

Complementary methods will be used alongside conventional physiotherapy.

Other: conventionalOther: traditional and complementary medicine methods

Interventions

hot application electrotherapy ultrasound mobilization joint range of motion exercises stretching exercises balance exercises posture exercises

conventional physiotherapycupping therapy and graston

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.

cupping therapy and graston

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Üsküdar Unıversıty

Üsküdar, Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 22907861BACKGROUND
  • 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.

    PMID: 18959807BACKGROUND
  • 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.

    PMID: 33920643BACKGROUND
  • 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.

    PMID: 30397006BACKGROUND
  • 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.

    PMID: 33947825BACKGROUND

MeSH Terms

Conditions

Neck Pain

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Beste İNCEKULAK

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: conservative and traditional physiotherapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 22, 2023

Study Start

September 1, 2023

Primary Completion

December 20, 2023

Study Completion

January 2, 2024

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations