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Analgesic Current Therapies for Chronic Neck Pain

Primary Purpose

Chronic Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neck stabilization exercise
TENS
IFC
Sponsored by
Hilal Yeşil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Neck Pain focused on measuring TENS, interferential current therapy, Chronic neck pain

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria: Having disc hernia that causes neurological deficit

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

Sites / Locations

  • Hilal Yesil

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Neck stabilization exercise

TENS+ neck stabilization exercise

IFC+ neck stabilization exercise

Arm Description

The patients who had only neck stabilization exercise

The patients who had both TENS and neck stabilization exercise

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change from baseline quality of life (short form- 36) at 6th and 12th weeks
This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health.
Change from baseline Beck depression inventory (BDI) at 6th and 12th weeks
The Beck Depression Inventory (BDI); was used to assess the depression levels of the patients. The BDI evaluates 21 symptoms of depression. These symptoms deal with emotions, behavioral changes, and somatic symptoms. Each symptom is rated on a 4-point intensity scale. Higher scores indicate more severe depression
Change from baseline Neck Pain and Disability Index at 6th and 12th weeks
The questionnaire consists of 20 items and measures neck movements, pain intensity, effect of neck pain on emotion factors, and interference with daily life activities. Each section is scored on a 0-5 rating scale and total score ranges from 0 to 100.

Full Information

First Posted
April 10, 2017
Last Updated
April 19, 2017
Sponsor
Hilal Yeşil
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1. Study Identification

Unique Protocol Identification Number
NCT03121859
Brief Title
Analgesic Current Therapies for Chronic Neck Pain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
April 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hilal Yeşil

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
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
Detailed Description
Analgesic therapies; such as interferential current (IFC) and transcutaneous electrical nerve stimulation (TENS) have been applied solo or combined with exercise for management of neck pain (NP), however, the efficacy of these combinations are unclear. In this study, our objective were to determine if TENS or IFC increase the effectiveness of neck stabilization exercises on pain, disability, mood, and quality of life for chronic NP. 81 patients with chronic NP were included in the study. Patients were randomly assigned into 3 groups; Group I: neck stabilization exercise, Group II: TENS+ neck stabilization exercise and Group III: IFC+ neck stabilization exercise. Patients' pain levels (visual analogue scale (VAS)), quality of life (short form- 36), mood (Beck depression inventory (BDI)), levels of disability (Neck Pain and Disability Index) and the need for analgesics were evaluated prior to treatment, at 6th and 12th week follow-up. All participants had group exercise accompanied by a physiotherapist for 3 weeks and an additional 3 weeks of home exercise program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
TENS, interferential current therapy, Chronic neck pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neck stabilization exercise
Arm Type
Active Comparator
Arm Description
The patients who had only neck stabilization exercise
Arm Title
TENS+ neck stabilization exercise
Arm Type
Active Comparator
Arm Description
The patients who had both TENS and neck stabilization exercise
Arm Title
IFC+ neck stabilization exercise
Arm Type
Active Comparator
Arm Description
The patients who had both interferential current therapy and neck stabilization exercise
Intervention Type
Other
Intervention Name(s)
Neck stabilization exercise
Intervention Description
Exercise
Intervention Type
Other
Intervention Name(s)
TENS
Intervention Description
Transcutaneous electrical nerve stimulation (TENS)
Intervention Type
Other
Intervention Name(s)
IFC
Intervention Description
Interferential current therapy(IFC)
Primary Outcome Measure Information:
Title
Change from baseline VAS (Visual analog scale) at 6th and 12th weeks
Description
The patients were asked to make an assessment of their pain between 0 (no pain) and 10 (severe pain).
Time Frame
Up to12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline quality of life (short form- 36) at 6th and 12th weeks
Description
This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health.
Time Frame
Up to 12 weeks
Title
Change from baseline Beck depression inventory (BDI) at 6th and 12th weeks
Description
The Beck Depression Inventory (BDI); was used to assess the depression levels of the patients. The BDI evaluates 21 symptoms of depression. These symptoms deal with emotions, behavioral changes, and somatic symptoms. Each symptom is rated on a 4-point intensity scale. Higher scores indicate more severe depression
Time Frame
Up to 12 weeks
Title
Change from baseline Neck Pain and Disability Index at 6th and 12th weeks
Description
The questionnaire consists of 20 items and measures neck movements, pain intensity, effect of neck pain on emotion factors, and interference with daily life activities. Each section is scored on a 0-5 rating scale and total score ranges from 0 to 100.
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both genders between 20-50 years, had chronic neck pain Exclusion Criteria: Having disc hernia that causes neurological deficit Having malignity, Having neck pain secondary neurological or vascular disease. Pregnancy Having psychiatric disease Having arthritic disease Having any contraindication for electrotherapy
Facility Information:
Facility Name
Hilal Yesil
City
Afyon
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
0300
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Analgesic Current Therapies for Chronic Neck Pain

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