NCT04882397

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

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

May 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 26, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2021

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2021

Completed
Last Updated

July 8, 2022

Status Verified

May 1, 2021

Enrollment Period

Same day

First QC Date

May 8, 2021

Last Update Submit

July 7, 2022

Conditions

Keywords

Joint Position SenseSoft TissueMobilizationNeck Pain

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Cervical Pain at 2 minutes

    Pain will be evaluated with Visual Analog Scale.

    Baseline and 2 minutes after intervention

  • Change from Baseline Joint Position Sense at 2 minutes

    Joint Position Sense will be evaluated Cervical Range of Motion Device

    Baseline and 2 minutes after intervention

Study Arms (3)

Instrument Assisted Soft Tissue Mobilization

EXPERIMENTAL

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

Other: Instrument Assisted Soft Tissue Mobilization

Sham Instrument Assisted Soft Tissue Mobilization

SHAM COMPARATOR

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

Other: Sham

Control

NO INTERVENTION

No application will be made to the control group.

Interventions

Bilateral Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.

Instrument Assisted Soft Tissue Mobilization
ShamOTHER

Bilateral sham Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.

Sham Instrument Assisted Soft Tissue Mobilization

Eligibility Criteria

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

You may qualify if:

  • Being diagnosed with chronic neck pain,
  • To be in the age range of 18-65.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, 42020, Turkey (Türkiye)

Location

Related Publications (1)

  • Gercek H, Unuvar BS, Umit Yemisci O, Aytar A. Acute effects of instrument assisted soft tissue mobilization technique on pain and joint position error in individuals with chronic neck pain: a double-blind, randomized controlled trial. Somatosens Mot Res. 2023 Mar;40(1):25-32. doi: 10.1080/08990220.2022.2157388. Epub 2022 Dec 20.

MeSH Terms

Conditions

Neck Pain

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2021

First Posted

May 12, 2021

Study Start

June 26, 2021

Primary Completion

June 26, 2021

Study Completion

July 20, 2021

Last Updated

July 8, 2022

Record last verified: 2021-05

Locations