NCT03121859

Brief Summary

Does the use of analgesic current therapies increase the effectiveness of neck stabilization exercises for improving pain, disability, mood, and quality of life in chronic neck pain? a randomized, controlled, single-blind study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

April 10, 2017

Last Update Submit

April 19, 2017

Conditions

Chronic Neck Pain

Keywords

TENSinterferential current therapyChronic neck pain

Outcome Measures

Primary Outcomes (1)

  • Change from baseline VAS (Visual analog scale) at 6th and 12th weeks

    The patients were asked to make an assessment of their pain between 0 (no pain) and 10 (severe pain).

    Up to12 weeks

Secondary Outcomes (3)

  • Change from baseline quality of life (short form- 36) at 6th and 12th weeks

    Up to 12 weeks

  • Change from baseline Beck depression inventory (BDI) at 6th and 12th weeks

    Up to 12 weeks

  • Change from baseline Neck Pain and Disability Index at 6th and 12th weeks

    Up to 12 weeks

Study Arms (3)

Neck stabilization exercise

ACTIVE COMPARATOR

The patients who had only neck stabilization exercise

Other: Neck stabilization exercise

TENS+ neck stabilization exercise

ACTIVE COMPARATOR

The patients who had both TENS and neck stabilization exercise

Other: Neck stabilization exerciseOther: TENS

IFC+ neck stabilization exercise

ACTIVE COMPARATOR

The patients who had both interferential current therapy and neck stabilization exercise

Other: Neck stabilization exerciseOther: IFC

Interventions

Neck stabilization exerciseOTHER

Exercise

IFC+ neck stabilization exerciseNeck stabilization exerciseTENS+ neck stabilization exercise
TENSOTHER

Transcutaneous electrical nerve stimulation (TENS)

TENS+ neck stabilization exercise
IFCOTHER

Interferential current therapy(IFC)

IFC+ neck stabilization exercise

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders between 20-50 years, had chronic neck pain

You may not qualify if:

  • Having malignity,
  • Having neck pain secondary neurological or vascular disease.
  • Pregnancy
  • Having psychiatric disease
  • Having arthritic disease
  • Having any contraindication for electrotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hilal Yesil

Afyonkarahisar, Eyalet/Yerleşke, 0300, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist Prof

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 20, 2017

Study Start

October 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 20, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)