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Completed

NCT Number: NCT06320340

Effectiveness of NMES on 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).

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Key information

Conditions

Chronic Neck Pain Behavior Motor Activity 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

İstanbul Aydın University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • (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.

Exclusion criteria

  • (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.

Treatment and study plan

Exercise

Other

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.

electrotherapy

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Pain intensity

    Time frame: baseline (first assessment)

    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.

  2. Pain intensity

    Time frame: at the end of the invervention program (8 weeks after from baseline)

    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.

  3. Range of Motion

    Time frame: baseline (first assessment)

    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.

  4. Range of Motion

    Time frame: at the end of the invervention program (8 weeks after from baseline)

    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.

  5. Static endurance of cervical deep flexor muscles

    Time frame: baseline (first assessment)

    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.

  6. Static endurance of cervical deep flexor muscles

    Time frame: at the end of the invervention program (8 weeks after from baseline)

    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.

  7. Fear of the movement

    Time frame: baseline (first assessment)

    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.

  8. Fear of the movement

    Time frame: at the end of the invervention program (8 weeks after from baseline)

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 20, 2024
Registry last updated
Mar 20, 2024

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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