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Completed

NCT Number: NCT03121859

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

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Key information

Conditions

Chronic Neck Pain

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hilal Yesil

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neck stabilization exercise

Other

Exercise

TENS

Other

Transcutaneous electrical nerve stimulation (TENS)

IFC

Other

Interferential current therapy(IFC)

Primary outcomes

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

    Time frame: Up to12 weeks

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

Secondary outcomes

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

    Time frame: Up to 12 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.

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

    Time frame: Up to 12 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

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

    Time frame: Up to 12 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.

Sponsors and collaborators

Lead sponsor

Hilal Yeşil

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 20, 2017
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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