Effectiveness of NMES on Neck Pain

Chronic Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06320340
• Other study ID #: 07032024
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: March 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 15, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Neck Pain
• Neck Pain

Intervention

Other:
• Exercise
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
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.

Locations

Country	Name	City	State
Turkey	Istanbul Aydin University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline (first assessment)
Primary	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.	at the end of the invervention program (8 weeks after from baseline)
Secondary	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.	baseline (first assessment)
Secondary	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.	at the end of the invervention program (8 weeks after from baseline)
Secondary	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.	baseline (first assessment)
Secondary	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.	at the end of the invervention program (8 weeks after from baseline)
Secondary	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.	baseline (first assessment)
Secondary	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.	at the end of the invervention program (8 weeks after from baseline)
Secondary	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.	baseline (first assessment)
Secondary	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.	at the end of the invervention program (8 weeks after from baseline)