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NCT Number: NCT03979287

Interferential Current and Therapeutic Exercise Program in Chronic Neck Pain

Objectives: To analyze the number of sessions needed to achieve a positive impact after combining interferential current therapy and therapeutic exercise, compared with therapeutic exercise alone, on self-reported pain, disability and range of motion in subjects with chronic neck pain.

Design: A randomized, single-blind, controlled trial. Subjects: Patients between 18 and 65 years old, with idiopathic chronic neck pain.

Methods: The experimental group who will perform a combined treatment using Interferential current therapy and therapeutic exercise for two weeks. The control group will receive the same program of therapeutic exercise during the same period of time.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sevilla

Seville, 41009, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Nonspecific mechanical neck pain (chronic neck pain diagnosed by a physician)
  • Age between 18 and 65 years old
  • Both males and females
  • Non apprehension to electrotherapy (determined by the Personal Psychological Apprehension scale- EAPP)
  • Self-reported pain higher than 2 in the 11-point Numeric Pain Rating Scale

Exclusion criteria

  • Metallic implants in the vertebral column
  • Apprehension to electrotherapy (a score >45 points in EAPP)
  • Cervicogenic headache
  • Cervicogenic Dizziness
  • Neck pain associated with neurological deficits
  • Unexplained fever
  • Cervical surgery associated to persistent pain
  • Specific diagnostics (cervical myelopathy, cervical stenosis, osteomyopathy)
  • Other diagnostics such as visceral pain referred to the neck or non-cervical cause.
  • Involvement in litigation
  • Manual treatment for the neck-shoulder area in the last month before data collection

Treatment and study plan

Interferential Current and Therapeutic Exercise Program

Other

The Interferential Current Program will be based on a bipolar application using the Sonopuls 692 device (Enraf Nonius, Rotterdam, The Netherlands). The current parameters will be: a) 4000Hz carrier frequency; and b) 60 Hz AMF with a modulation frequency of 90 Hz. The intensity of the current will be adapted to the sensitivity of each patient.

The Therapeutic Exercise Program will be applied by a physiotherapist and will consist of:

  • Ergonomic advices on reducing repetitive movements and/or maintained positions
  • A protocol of active physiotherapy for neck and shoulder muscles. This protocol will include: active stretching exercises; isometric muscle strengthening exercises; reeducation of the ocular and neck muscles with control retraining exercises

Therapeutic Exercise Program

Other

The Therapeutic Exercise Program will be applied by a physiotherapist and will consist of:

  • Ergonomic advices on reducing repetitive movements and/or maintained positions
  • A protocol of active physiotherapy for neck and shoulder muscles. This protocol will include: active stretching exercises; isometric muscle strengthening exercises; reeducation of the ocular and neck muscles with control retraining exercises

Primary outcomes

  1. Neck pain intensity

    Time frame: From baseline to immediately after treatment

    Participants will rate the intensity of their neck pain at rest on an 11-point numeric pain rating scale, where 0 is no pain and 11 maximum pain. The subjects will be ask to indicate the pain levels that they experienced before treatment and after treatment.

  2. Disability

    Time frame: From baseline to immediately after treatment

    The Neck Disability Index (NDI) will be used in the Spanish version to measure level of disability of the neck area during the daily life activities.

    where under 9 denotes No Disability; from 10 to 29 denotes Slight Disability; from 30 to 49 denotes Moderate Disability; from 50 to 69 denotes Severe Disability and more tan 70 denote Complete Disability.

Secondary outcomes

  1. Range of movement (ROM)

    Time frame: From baseline to immediately after treatment

    The secondary outcome measure will be the active cervical range of motion assessed with the CROM device (Performance Attainment Associates, Lindstrom, MN). The measurements will be made separately for each direction and in a standard sequence: flexion, extension, right lateral flexion, left lateral flexion, right rotation and left rotation. Two measurements will be recorded for each movement and the average of the two measurements will be used in the analysis of results

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

Efficacy of a Interferential Current and Therapeutic Exercise Program in Subjects With Chronic Neck Pain

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2019
Registry last updated
Feb 5, 2020

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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