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Immidate Effect of Instrument Assited Soft Tissue Mobilization Technique on Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Instrument Assisted Soft Tissue Mobilization
Sham
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Joint Position Sense, Soft Tissue, Mobilization, Neck Pain

Eligibility Criteria

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

Inclusion Criteria:

  • • Being diagnosed with chronic neck pain,

    • To be in the age range of 18-65.

Exclusion Criteria:

  • • Those taking any analgesic medication

    • Those with acute injury or infection,
    • Those with open wounds, Osteoporosis,
    • Broken,
    • Hematoma, Those with acute cardiac, liver and kidney problems,
    • Those with connective tissue disease, Rheumatoid arthritis, osteoarthritis, Cancer,
    • Those with circulation problems,
    • Those with peripheral vascular disease, Epilepsy, Surgery history in the cervical area

Sites / Locations

  • KTO Karatay University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Instrument Assisted Soft Tissue Mobilization

Sham Instrument Assisted Soft Tissue Mobilization

Control

Arm Description

In the application group, Instrument Assisted Soft Tissue Mobilization will be applied to the Trapezius and Sternocleideomastoideus muscles for 90 seconds.

In the sham application group, 90 degrees to 90 seconds will be applied to the Trapezius and Sternocleideomastoideus muscles without applying pressure.

No application will be made to the control group.

Outcomes

Primary Outcome Measures

Change from Baseline Cervical Pain at 2 minutes
Pain will be evaluated with Visual Analog Scale.
Change from Baseline Joint Position Sense at 2 minutes
Joint Position Sense will be evaluated Cervical Range of Motion Device

Secondary Outcome Measures

Full Information

First Posted
May 8, 2021
Last Updated
July 7, 2022
Sponsor
KTO Karatay University
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1. Study Identification

Unique Protocol Identification Number
NCT04882397
Brief Title
Immidate Effect of Instrument Assited Soft Tissue Mobilization Technique on Chronic Neck Pain
Official Title
Immidate Effect of Instrument Assited Soft Tissue Mobilization Technique on Pain and Joint Position Sense in Individuals With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 26, 2021 (Actual)
Primary Completion Date
June 26, 2021 (Actual)
Study Completion Date
July 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KTO Karatay 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
Chronic neck pain causes errors in joint position. There are studies in the literature suggesting that the application of instrument-assisted soft tissue mobilization improves the sense of joint position. There are no studies that acutely examine this practice on joint position sense and pain in the cervical region. As a result of our study, we will investigate the effects of instrument-assisted soft tissue mobilization in a single session on perception of pain and joint position.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Joint Position Sense, Soft Tissue, Mobilization, Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Instrument Assisted Soft Tissue Mobilization
Arm Type
Experimental
Arm Description
In the application group, Instrument Assisted Soft Tissue Mobilization will be applied to the Trapezius and Sternocleideomastoideus muscles for 90 seconds.
Arm Title
Sham Instrument Assisted Soft Tissue Mobilization
Arm Type
Sham Comparator
Arm Description
In the sham application group, 90 degrees to 90 seconds will be applied to the Trapezius and Sternocleideomastoideus muscles without applying pressure.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No application will be made to the control group.
Intervention Type
Other
Intervention Name(s)
Instrument Assisted Soft Tissue Mobilization
Intervention Description
Bilateral Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Bilateral sham Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.
Primary Outcome Measure Information:
Title
Change from Baseline Cervical Pain at 2 minutes
Description
Pain will be evaluated with Visual Analog Scale.
Time Frame
Baseline and 2 minutes after intervention
Title
Change from Baseline Joint Position Sense at 2 minutes
Description
Joint Position Sense will be evaluated Cervical Range of Motion Device
Time Frame
Baseline and 2 minutes after intervention

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 diagnosed with chronic neck pain, To be in the age range of 18-65. Exclusion Criteria: • Those taking any analgesic medication Those with acute injury or infection, Those with open wounds, Osteoporosis, Broken, Hematoma, Those with acute cardiac, liver and kidney problems, Those with connective tissue disease, Rheumatoid arthritis, osteoarthritis, Cancer, Those with circulation problems, Those with peripheral vascular disease, Epilepsy, Surgery history in the cervical area
Facility Information:
Facility Name
KTO Karatay University
City
Konya
ZIP/Postal Code
42020
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Immidate Effect of Instrument Assited Soft Tissue Mobilization Technique on Chronic Neck Pain

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