NCT06320340

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 9, 2024

Last Update Submit

March 16, 2024

Conditions

Keywords

cervical spineexerciseneck painneuromuscular electrical stimulation

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 COMPARATOR
Other: Exercise

Group II

EXPERIMENTAL
Other: ExerciseOther: Electrotherapy

Interventions

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.

Group IGroup II

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.

Group II

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Motor ActivityNeck Pain

Interventions

ExerciseElectric Stimulation Therapy

Condition Hierarchy (Ancestors)

BehaviorPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaTherapeuticsPhysical Therapy ModalitiesRehabilitation

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

Locations