NCT04645095

Brief Summary

The aim of this project is to compare the effects of conventional, burst and modulated TENS primarily on pain level, number of trigger points, pressure pain threshold, neck joint range of motion and disability in MAS treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

2.6 years

First QC Date

November 23, 2020

Last Update Submit

November 23, 2020

Conditions

Myofascial Pain Syndromes

Keywords

Myofascial Pain SyndromesTranscutaneous Electrical Nerve Stimulation

Outcome Measures

Primary Outcomes (5)

  • Pain intensity

    using Visual Analog Scale score; (0-10); 0 indicates no pain and 10 indicates worst imaginable pain

    Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.

  • Number of trigger points in the upper back region

    using number

    Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.

  • Pressure pain

    using algometer (kg/cm2)

    Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.

  • Neck joint range of motion

    using double inclinometer

    Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.

  • Disability

    using Modified Neck Disability Index

    Measurements will be made before treatment, at the 1st week after treatment and at the 1st month after treatment.

Study Arms (3)

Conventional TENS

ACTIVE COMPARATOR

Frequency:80 Hz, duration:100 μs

Device: Transcutaneous electrical nerve stimulationDevice: Hot pack

Burst TENS

ACTIVE COMPARATOR

Frequency:100 Hz, fr mod: 0, 200 µs, 2 Bps Hz

Device: Transcutaneous electrical nerve stimulationDevice: Hot pack

Modulated TENS

ACTIVE COMPARATOR

Frequency:80 Hz, fr mod: 50%, Amplitude mode: 40%, duration: 200 µs

Device: Transcutaneous electrical nerve stimulationDevice: Hot pack

Interventions

Transcutaneous electrical nerve stimulationDEVICE

All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.

Also known as: TENS
Burst TENSConventional TENSModulated TENS
Hot packDEVICE

All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.

Burst TENSConventional TENSModulated TENS

Eligibility Criteria

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

You may qualify if:

  • Having a diagnosis of myofascial pain syndrome according to the criteria defined by Travell and Simons

You may not qualify if:

  • The onset of symptoms is less than 3 months
  • Severe cervical disc hernia, radiculopathy or myelopathy
  • Stage 3-4 cervical degeneration
  • Tumoral, infectious, psychiatric, neurological, uncontrolled systemic disease
  • Cardiac pacemaker
  • Diagnosed with fibromyalgia syndrome
  • Kyphoscoliosis
  • Acute trauma history
  • Having had previous brain or shoulder surgery
  • Injections for MAS and / or physiotherapy programs in the last 3 months
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Birkan Sonel Tur

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Birkan Sonel Tur, Prof.

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor; MD

Study Record Dates

First Submitted

November 23, 2020

First Posted

November 27, 2020

Study Start

May 5, 2017

Primary Completion

December 6, 2019

Study Completion

March 1, 2020

Last Updated

November 27, 2020

Record last verified: 2020-11

Locations

TU(1)