Effectiveness of NMES on Neck Pain
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
1 other identifier
interventional
36
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2021
CompletedFirst Submitted
Initial submission to the registry
March 9, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedMarch 20, 2024
March 1, 2024
2 months
March 9, 2024
March 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
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 Outcomes (8)
Pain intensity
baseline (first assessment)
Pain intensity
at the end of the invervention program (8 weeks after from baseline)
Range of Motion
baseline (first assessment)
Range of Motion
at the end of the invervention program (8 weeks after from baseline)
Static endurance of cervical deep flexor muscles
baseline (first assessment)
- +3 more secondary outcomes
Study Arms (2)
Group I
ACTIVE COMPARATORGroup II
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
İstanbul Aydın University
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PT, MSc, Research Assistant, Principal Investigator
Study Record Dates
First Submitted
March 9, 2024
First Posted
March 20, 2024
Study Start
March 15, 2021
Primary Completion
May 15, 2021
Study Completion
September 15, 2021
Last Updated
March 20, 2024
Record last verified: 2024-03