Neck PainNCT03979287
Interferential Current and Therapeutic Exercise Program in Chronic Neck Pain
A study testing Interferential Current and Therapeutic Exercise Program and Therapeutic Exercise Program in people with Neck Pain, run by University of Seville at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Interferential Current and Therapeutic Exercise Program and Therapeutic Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jul 2019to 15 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Interferential Current and Therapeutic Exercise Program in Subjects With 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.
- Conditions
- Neck Pain
- Being tested
- Interferential Current and Therapeutic Exercise Program, Therapeutic Exercise Program
- Keywords
- Chronic Neck Pain, Interferential Current Electrotherapy, Therapeutic Exercise, Physical Therapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferential Current and Therapeutic Exercise ProgramOther
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 ProgramOther
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
| Study group | Role | What they receive |
|---|---|---|
| IFC and Therapeutic Exercise Program | Experimental | Patients will receive 10 sessions for two weeks. The duration of each session will be of approximately one hour. Participants will receive treatment with Interferential current therapy plus a program of therapeutic exercise focused on the neck region Receives: Other: Interferential Current and Therapeutic Exercise Program |
| Therapeutic Exercise Program | Active comparator | Patients will receive 10 sessions for two weeks. The duration of each session will be of approximately one hour.This group will only receive the same therapeutic exercise program. Receives: Other: Therapeutic Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain intensity
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.
Measured: From baseline to immediately after treatment
Disability
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.
Measured: From baseline to immediately after treatment
Secondary outcomes (1)
Range of movement (ROM)
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
Measured: From baseline to immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start13 Jul 2019
- Primary completion25 Oct 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Marcos Heredia-Rizo, University of Seville
- Investigators
- Alberto Heredia-Rizo, PhD, Study director, Physiotherapy Department, University of Seville, spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979287
- Sponsor's protocol ID
- IFC Therapy and Exercise
- Status last verified
- Feb 2020
- First submitted
- 5 Jun 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Interferential Current and Therapeutic Exercise Program in Subjects With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT03979287
- Acronym / sponsor ID
- IFC Therapy and Exercise
- Conditions
- Neck Pain
- Keywords
- Chronic Neck Pain, Interferential Current Electrotherapy, Therapeutic Exercise, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 13 Jul 2019 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IFC and Therapeutic Exercise Program | Experimental | Other: Interferential Current and Therapeutic Exercise ProgramPatients will receive 10 sessions for two weeks. The duration of each session will be of approximately one hour. Participants will receive treatment with Interferential current therapy plus a program of therapeutic exercise focused on the neck region |
| Therapeutic Exercise Program | Active comparator | Other: Therapeutic Exercise ProgramPatients will receive 10 sessions for two weeks. The duration of each session will be of approximately one hour.This group will only receive the same therapeutic exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferential Current and Therapeutic Exercise ProgramThe 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: 1. Ergonomic advices on reducing repetitive movements and/or maintained positions 2. 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 | Other | IFC and Therapeutic Exercise Program |
| Therapeutic Exercise ProgramThe Therapeutic Exercise Program will be applied by a physiotherapist and will consist of: 1. Ergonomic advices on reducing repetitive movements and/or maintained positions 2. 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 | Other | Therapeutic Exercise Program |
Primary outcome
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.
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.
1 secondary outcome
Range of movement (ROM)
Time frame: From baseline to immediately after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Heredia-Rizo, PhD study director
Physiotherapy Department, University of Seville, spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interferential Current and Therapeutic Exercise Program and Therapeutic Exercise Program in people with Neck Pain, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck pain intensity (time frame: From baseline to immediately after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.