NCT02656030

Brief Summary

Recent studies indicate that the patients with chronic neck pain present decreased activation and weak of neck muscles, especially deep flexor and extensor muscles. Alterations of deep are associated with pain and impairment of neck function in chronic neck pain. Exercise is known to be an important component of treatment programs for patients with neck pain. Recently, many studies have focused on specific training on deep cervical muscles, especially deep cervical flexor and deep cervical extensor muscles.Numerous studies using cranio-cervical flexor exercise as a treatment have revealed reduction on pain, neck disability, changing in activation of deep cervical flexor muscles. Further, the cervical extensor muscles are believed to be equally important for the rehabilitation of patients with neck pain. However, the retention effect of semispinalis cervicis exercise is unknown. Therefore, the semispinalis cervicis exercise still need more evidence to support clinically effects. The current study will be conducted to fill the gap of the previous study in immediately, short, and long term effects of semispinalis cervicis exercise in chronic neck pain.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

1.6 years

First QC Date

January 11, 2016

Last Update Submit

February 12, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Index

    Up to 3-months after the last intervention session

Study Arms (3)

semispinalis cervicis resisted exercise

EXPERIMENTAL

semispinalis cervicis resisted exercise 2 times/week, 6 weeks duration

Other: semispinalis cervicis resisted exercise

cranio-cervical flexion exercise

EXPERIMENTAL

cranio-cervical flexion exercise 2 times/week, 6 weeks duration

Other: cranio-cervical flexion exercise

usual care

ACTIVE COMPARATOR

Usual care 2 times/week, 6 weeks duration

Other: usual care

Interventions

semispinalis cervicis resisted exercise, 2 time per week, 6 weeks duration

semispinalis cervicis resisted exercise

cranio-cervical flexion exercise, 2 time per week, 6 weeks duration

cranio-cervical flexion exercise

usual care, 2 time per week, 6 weeks duration

usual care

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic mechanical neck pain
  • Aged between 18 to 59 years
  • The symptom more than three months in duration
  • A baseline the Thai version of Neck Disability Index (NDI-TH) score of 10 percent or greater

You may not qualify if:

  • a previous history of whiplash injury
  • a previous history injury to the cervical and thoracic spine
  • diagnosed with osteoporosis, malignancy or other spinal inflection
  • a positive vertebro-basilar artery insufficient test
  • diagnosed with cervical radiculopathy and/or myelopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Center in Back, Neck, Other Joint Pain and Human Performance, Khon Kaen University

Muang, Changwat Khon Kaen, 40002, Thailand

RECRUITING

Related Publications (3)

  • Falla D, O'Leary S, Farina D, Jull G. The change in deep cervical flexor activity after training is associated with the degree of pain reduction in patients with chronic neck pain. Clin J Pain. 2012 Sep;28(7):628-34. doi: 10.1097/AJP.0b013e31823e9378.

  • Schomacher J, Petzke F, Falla D. Localised resistance selectively activates the semispinalis cervicis muscle in patients with neck pain. Man Ther. 2012 Dec;17(6):544-8. doi: 10.1016/j.math.2012.05.012. Epub 2012 Jun 22.

  • Suvarnnato T, Puntumetakul R, Uthaikhup S, Boucaut R. Effect of specific deep cervical muscle exercises on functional disability, pain intensity, craniovertebral angle, and neck-muscle strength in chronic mechanical neck pain: a randomized controlled trial. J Pain Res. 2019 Mar 7;12:915-925. doi: 10.2147/JPR.S190125. eCollection 2019.

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thavatchai Suvarnnato, M.Sc. PT

    Research Center in Back, Neck, Other Joint Pain and Human Performance, Khon Kaen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thavatchai Suvarnnato, M.Sc. PT

CONTACT

Thavatchai Suvarnnato, M.Sc. PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Member of Research Center in Back, Neck, Other Joint Pain and Human Performance

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 14, 2016

Study Start

November 1, 2015

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

February 15, 2016

Record last verified: 2016-02

Locations