NCT04704102

Brief Summary

This is a prospective case series study.There were 20 individuals with chronic neck pain accompanied by myogenous temporomandibular disorders(mTMD) from Linkou and Taoyuan Chang Gung hospitals, and Chang-Gung university. The purpose of this study was, first, to investigate the effects of muscle energy technique (MET) or strain-counterstrain (SCS) applied on the tender or trigger points of neck muscles on improving pain and pressure pain sensitivity in neck and masticatory muscles, the maximal mouth-opening range of motion, chewing endurance, and head-neck-shoulder posture in patients with chronic neck pain accompanied by mTMD. Second, whether the significant effects could be reached within the four-week intervention duration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

First Submitted

Initial submission to the registry

January 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 11, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 6, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

January 8, 2021

Last Update Submit

July 30, 2021

Conditions

Keywords

myogenous temporomandibular disorders, neck pain, muscle energy technique, strain-counterstrain, head-neck posture

Outcome Measures

Primary Outcomes (2)

  • Pain intensity in neck and masticatory muscles

    ask participants the self-report pain intensity with the NPRS scale

    4 weeks

  • Tenderness sensitivity in neck and masticatory muscles

    measure the pressure pain threshold with digital pressure algometer

    4 weeks

Secondary Outcomes (3)

  • Maximal mouth-opening

    4 weeks

  • Chewing endurance

    4 weeks

  • Head-neck-shoulder posture

    4 weeks

Study Arms (3)

Muscle energy technique group

EXPERIMENTAL

Use one of the muscle energy technique methods -- postisometric relaxation technique(PIR) as the intervention method.

Behavioral: Muscle energy technique (MET)

Strain-counterstrain group

EXPERIMENTAL

Use the Strain-counterstrain technique as the intervention method.

Behavioral: Strain-counterstrain (SCS)

Control group

SHAM COMPARATOR

Use the modified Strain-counterstrain technique as the intervention method.

Behavioral: sham SCS

Interventions

A manual therapy technique that uses the gentle muscle contractions of the patient to relax and lengthen muscles and normalize joint motion.

Muscle energy technique group

It's also called the "positional release technique", a manual therapy technique that passively positions the hypertonic (spasmed) muscles and dysfunctional joints in positions of shortened or comfort.

Strain-counterstrain group
sham SCSBEHAVIORAL

SCS intervention that position with opposite site limb and direction, and with modified method as consider the easiness of a practitioner to press the tender points

Control group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 20\~65
  • Self-report neck pain ≥3 months (pain occurs between superior nuchal line and 1st level of thoracic spine)
  • At least one tender point at both Upper trapezius and Sternocleidomastoid muscles
  • Diagnosed as mTMD according to the Diagnostic Criteria for Temporomandibular Disorders(DC/TMD)

You may not qualify if:

  • Cognitive deficit
  • Malignancy, infection, cervical or orthognathic surgery, acute pain, and history of trauma in craniocervical region
  • Neurological problem or cervical radiculopathy/myelopathy
  • Cervical instability with positive rotational alar ligament stress test and transverse ligament stress test, jaw dislocation
  • Tooth implantation or extraction a week before study
  • Vertebrobasilar insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yang-Hua, Lin

Taoyuan District, 33302, Taiwan

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Include elements of both longitudinal (three groups) and cross-sectional (four-weeks intervention) research designs
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 11, 2021

Study Start

January 11, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

August 6, 2021

Record last verified: 2021-07

Locations