Chronic Neck PainNCT06320340
Effectiveness of NMES on Neck Pain
A study testing Exercise and Electrotherapy in people with Chronic Neck Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized-controlled study was to determine the effectiveness of neuromuscular electrical stimulation (NMES) applied simultaneously to exercise on pain, static endurance of cervical deep flexor muscles, fear of movement and disability in chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Exercise and Electrotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2021to 15 Sep 2021
- 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
- (1) being aged from 18 to 65 years old,
- (2) having neck pain shows mechanical nature longer than 3 months, and
- (3) getting a score of at least 10 from Neck Disability Index.
Who cannot join
- (1) having a surgery on neck and shoulder regions,
- (2) having a neurological symptom, and
- (3) did not complete the process of the assessment and intervention of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Neuromuscular Electrical Stimulation Applied Simultaneously to Exercise on Pain, Range of Motion, Muscle Endurance, Fear of Movement and Disability in Chronic Neck Pain
The aim of this randomized-controlled study was to determine the effectiveness of neuromuscular electrical stimulation (NMES) applied simultaneously to exercise on pain, static endurance of cervical deep flexor muscles, fear of movement and disability in chronic neck pain. The participants were randomly assigned to one group which in only five clinical pilates exercises were performed (Group I) or the other group which NMES was applied on lower trapezius and serratus anterior muscles while the same exercises were performing (Group II).
Read the detailed description
The aim of randomized-controlled study was to determine the effectiveness of neuromuscular electrical stimulation (NMES) applied simultaneously to exercise on pain, static endurance of cervical deep flexor muscles, fear of movement and disability in chronic neck pain. This study, including adults with chronic neck pain aged between 18-65 years, was conducted in laboratory of xxx University from March 2021 to May 2021. The participants were randomly assigned to one group which in only five clinical pilates exercises were performed (Group I) or the other group which NMES was applied on lower trapezius and serratus anterior muscles while the same exercises were performing (Group II). Both groups received 20 minutes of treatment session two days a week for the 8 weeks. The pain intensity, range of motion (ROM), static endurance of cervical deep flexor muscles, fear of movement, and neck disability were assessed with Visual Analogue (VAS), universal goniometer, The Deep Neck Flexor (DNF) Endurance Test, Tampa Scale of Kinesiophobia (TSK) and Neck Disability Index (NDI), respectively. All the assessments were performed twice as before and end of the treatment.
- Conditions
- Chronic Neck Pain
- Being tested
- Exercise, Electrotherapy
- Keywords
- cervical spine, exercise, neck pain, neuromuscular electrical stimulation
- Medical subject headings
- Motor Activity, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
the patients were performed following five exercises for 20 minutes of treatment session two days a week for the 8 weeks.: (1) the swan-dive vol. I, (2) the swan-dive vol II., (3) breast stroke preparation vol. I, (4) breast stroke preparation vol. II, and (5) swimming vol. II. All the exercises were repeated for the 10 times in a session. Before the exercises, patients were taught and instructed about the five key elements (lateral expansion, centralization, positioning the chest, the shoulder girdle, and the head) of clinical pilates that they should pay attention to while performing the exercises. In addition, verbal and tactile feedbacks were given to patients during all the treatment sessions to maintain the good posture and to perform exercises properly.
ElectrotherapyOther
Two channels of four-channelled Compex SP Fit-3 (MediCompex SA in Geneva, Switzerland) was used to apply NMES (120 mA, 400 μs, 150 Hz) on lower trapezius and serratus anterior muscles for 20 minutes during exercise.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Not described Receives: Other: Exercise |
| Group II | Experimental | Not described Receives: Other: Exercise; Other: Electrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck disability
The Neck Disability Index consisted 10 questions investigating the pain intensity and difficulty in lifting, reading, concentration, working, sleeping and recreational activities. Each question is scoring from 0 to 5 and higher score means greater disability.
Measured: baseline (first assessment)
Neck disability
The Neck Disability Index consisted 10 questions investigating the pain intensity and difficulty in lifting, reading, concentration, working, sleeping and recreational activities. Each question is scoring from 0 to 5 and higher score means greater disability.
Measured: at the end of the invervention program (8 weeks after from baseline)
Secondary outcomes (8)
Pain intensity
The neck pain intensity of the participants were assessed with VAS which is a widely used pain assessments in the musculoskeletal disorders. The participants were asked to rate their pain intensity with a mark on a 10 cm line, which starts with "0-no pain" and ends with "10-unbearable pain". The distance of the mark to the 0 point was measured with a ruler and the pain intensity was recorded as cm.
Measured: baseline (first assessment)
Pain intensity
The neck pain intensity of the participants were assessed with VAS which is a widely used pain assessments in the musculoskeletal disorders. The participants were asked to rate their pain intensity with a mark on a 10 cm line, which starts with "0-no pain" and ends with "10-unbearable pain". The distance of the mark to the 0 point was measured with a ruler and the pain intensity was recorded as cm.
Measured: at the end of the invervention program (8 weeks after from baseline)
Range of Motion
Cervical ROM in all six directions (flexion-extension, lateral flexion, and rotation) were assessed with universal goniometer. Universal goniometer were shown to have good to excellent intra-rater and inter-rater reliability to assess ROM of cervical spine (10.1093/ptj/71.2.98). The measurement were performed as described in (https://doi.org/10.21315/mjms2021.28.2.9). The measurement of each six directions were repeated three times and means were recorded as degree.
Measured: baseline (first assessment)
Range of Motion
Cervical ROM in all six directions (flexion-extension, lateral flexion, and rotation) were assessed with universal goniometer. Universal goniometer were shown to have good to excellent intra-rater and inter-rater reliability to assess ROM of cervical spine (10.1093/ptj/71.2.98). The measurement were performed as described in (https://doi.org/10.21315/mjms2021.28.2.9). The measurement of each six directions were repeated three times and means were recorded as degree.
Measured: at the end of the invervention program (8 weeks after from baseline)
Static endurance of cervical deep flexor muscles
Deep Neck Flexor ((longus capitis, longus colli, rectus capitis anterior and lateralis) Endurance Test was used to static endurance of cervical deep flexor muscles. The subjects began in a supine, hook-lying position, with the hands resting on the abdomen. Upon request, with the chin in maximally tucked position and maintained isometrically, the subject lifted the head and neck approximately 2.5 cm from resting position The duration of holding the head position properly was timed, and static endurance of the DNF was recorded as second.
Measured: baseline (first assessment)
Static endurance of cervical deep flexor muscles
Deep Neck Flexor ((longus capitis, longus colli, rectus capitis anterior and lateralis) Endurance Test was used to static endurance of cervical deep flexor muscles. The subjects began in a supine, hook-lying position, with the hands resting on the abdomen. Upon request, with the chin in maximally tucked position and maintained isometrically, the subject lifted the head and neck approximately 2.5 cm from resting position The duration of holding the head position properly was timed, and static endurance of the DNF was recorded as second.
Measured: at the end of the invervention program (8 weeks after from baseline)
Fear of the movement
Tampa Scale of Kinesiophobia is a Likert type questionnaire consisted of 17 questions scoring from "1-strongly disagree" to "4-strongly agree". Scoring of questions 4, 8, 12, and 16 are reversed. The higher score means greater fear of movement.
Measured: baseline (first assessment)
Fear of the movement
Tampa Scale of Kinesiophobia is a Likert type questionnaire consisted of 17 questions scoring from "1-strongly disagree" to "4-strongly agree". Scoring of questions 4, 8, 12, and 16 are reversed. The higher score means greater fear of movement.
Measured: at the end of the invervention program (8 weeks after from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start15 Mar 2021
- Primary completion15 May 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aybike Senel, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320340
- Sponsor's protocol ID
- 07032024
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared on request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Neuromuscular Electrical Stimulation Applied Simultaneously to Exercise on Pain, Range of Motion, Muscle Endurance, Fear of Movement and Disability in Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06320340
- Acronym / sponsor ID
- 07032024
- Conditions
- Chronic Neck Pain
- Keywords
- cervical spine, exercise, neck pain, neuromuscular electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 20 Mar 2024 (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.
The aim of this randomized-controlled study was to determine the effectiveness of neuromuscular electrical stimulation (NMES) applied simultaneously to exercise on pain, static endurance of cervical deep flexor muscles, fear of movement and disability in chronic neck pain. The participants were randomly assigned to one group which in only five clinical pilates exercises were performed (Group I) or the other group which NMES was applied on lower trapezius and serratus anterior muscles while the same exercises were performing (Group II).
Detailed description
The aim of randomized-controlled study was to determine the effectiveness of neuromuscular electrical stimulation (NMES) applied simultaneously to exercise on pain, static endurance of cervical deep flexor muscles, fear of movement and disability in chronic neck pain. This study, including adults with chronic neck pain aged between 18-65 years, was conducted in laboratory of xxx University from March 2021 to May 2021. The participants were randomly assigned to one group which in only five clinical pilates exercises were performed (Group I) or the other group which NMES was applied on lower trapezius and serratus anterior muscles while the same exercises were performing (Group II). Both groups received 20 minutes of treatment session two days a week for the 8 weeks. The pain intensity, range of motion (ROM), static endurance of cervical deep flexor muscles, fear of movement, and neck disability were assessed with Visual Analogue (VAS), universal goniometer, The Deep Neck Flexor (DNF) Endurance Test, Tampa Scale of Kinesiophobia (TSK) and Neck Disability Index (NDI), respectively. All the assessments were performed twice as before and end of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Other: Exercise |
| Group II | Experimental | Other: Exercise, Other: Electrotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (1) being aged from 18 to 65 years old,
- (2) having neck pain shows mechanical nature longer than 3 months, and
- (3) getting a score of at least 10 from Neck Disability Index.
Key exclusion criteria (3 listed)
- (1) having a surgery on neck and shoulder regions,
- (2) having a neurological symptom, and
- (3) did not complete the process of the assessment and intervention of this study.
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 |
|---|---|---|
| Exercisethe patients were performed following five exercises for 20 minutes of treatment session two days a week for the 8 weeks.: (1) the swan-dive vol. I, (2) the swan-dive vol II., (3) breast stroke preparation vol. I, (4) breast stroke preparation vol. II, and (5) swimming vol. II. All the exercises were repeated for the 10 times in a session. Before the exercises, patients were taught and instructed about the five key elements (lateral expansion, centralization, positioning the chest, the shoulder girdle, and the head) of clinical pilates that they should pay attention to while performing the exercises. In addition, verbal and tactile feedbacks were given to patients during all the treatment sessions to maintain the good posture and to perform exercises properly. | Other | Group I, Group II |
| ElectrotherapyTwo channels of four-channelled Compex SP Fit-3 (MediCompex SA in Geneva, Switzerland) was used to apply NMES (120 mA, 400 μs, 150 Hz) on lower trapezius and serratus anterior muscles for 20 minutes during exercise. | Other | Group II |
Primary outcome
Neck disability
Time frame: baseline (first assessment)
The Neck Disability Index consisted 10 questions investigating the pain intensity and difficulty in lifting, reading, concentration, working, sleeping and recreational activities. Each question is scoring from 0 to 5 and higher score means greater disability.
Neck disability
Time frame: at the end of the invervention program (8 weeks after from baseline)
The Neck Disability Index consisted 10 questions investigating the pain intensity and difficulty in lifting, reading, concentration, working, sleeping and recreational activities. Each question is scoring from 0 to 5 and higher score means greater disability.
8 secondary outcomes
Pain intensity
Time frame: baseline (first assessment)
Pain intensity
Time frame: at the end of the invervention program (8 weeks after from baseline)
Range of Motion
Time frame: baseline (first assessment)
Range of Motion
Time frame: at the end of the invervention program (8 weeks after from baseline)
Static endurance of cervical deep flexor muscles
Time frame: baseline (first assessment)
Static endurance of cervical deep flexor muscles
Time frame: at the end of the invervention program (8 weeks after from baseline)
Fear of the movement
Time frame: baseline (first assessment)
Fear of the movement
Time frame: at the end of the invervention program (8 weeks after from baseline)
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 20 Mar 2024.
- Individual participant dataSharing planned: Undecided. Data will be shared on request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Electrotherapy in people with Chronic Neck Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 20 Mar 2024. 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 Turkey (Türkiye). 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 disability (time frame: baseline (first assessment)). 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 20 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.