Analgesic Current Therapies for Chronic Neck Pain

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

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 Overview

• Status: Completed
• Conditions: Chronic Neck Pain
• Intervention / Treatment: Other: Neck stabilization exercise; Other: TENS; Other: IFC

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Eyalet/Yerleşke
    • Afyon, Eyalet/Yerleşke, Turkey, 0300
      • Hilal Yeşil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neck stabilization exercise; The patients who had only neck stabilization exercise	Other: Neck stabilization exercise; Exercise
Active Comparator: TENS+ neck stabilization exercise; The patients who had both TENS and neck stabilization exercise	Other: Neck stabilization exercise; Exercise; Other: TENS; Transcutaneous electrical nerve stimulation (TENS)
Active Comparator: IFC+ neck stabilization exercise; The patients who had both interferential current therapy and neck stabilization exercise	Other: Neck stabilization exercise; Exercise; Other: IFC; Interferential current therapy(IFC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 weeks
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	Up to 12 weeks
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.	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Hilal Yeşil

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: TENS; Chronic neck pain; interferential current therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 2017-SHHY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No