NCT03702075

Brief Summary

Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck movements or sustained neck postures. The onset and course of this pain are influenced by environmental and personal factors. Many studies report that participants preferred self-care measures for the management of neck pain and they sought professional help only when those measures fail.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2018

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

October 8, 2018

Last Update Submit

October 10, 2018

Conditions

Keywords

chronic neck pain

Outcome Measures

Primary Outcomes (1)

  • Trigger points examination

    Trigger points will be explored bilaterally by a blinded assessor in suboccipital, scalene, levator scapulae and upper trapezius muscles

    Change from baseline trigger points examination at 4 weeks

Secondary Outcomes (6)

  • Pain severity

    Change from baseline pain at 4 weeks

  • Functionality

    Change from baseline functionality at 4 weeks

  • Cervical range of motion

    Change from baseline cervical range of motion at 4 weeks

  • Health related quality of life

    Change from baseline health related quality of life at 4 weeks

  • Fear avoidance beliefs

    Change from baseline fear avoidance beliefs at 4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients allocated to the experimental group were included in a self-administered program combining self-myofascial release using foam rollers and roller balls and active upper limb neurodynamic exercises. It consisted of three sessions of 50-60 minutes per week for 4 consecutive weeks.

Other: self-administered program

Control group

NO INTERVENTION

Those patients allocated to the control group received a booklet with information regarding neck pain and explaining basic exercises for active mobilization and stretching with pictures and a short text.

Interventions

One session was a session supervised by a physical therapist in the Faculty of Health Sciences. This session took place in groups of three or four people. All participants had to follow the physiotherapist instructions about the correct way to do the exercises with the foam roller or ball and nerve mobilizations of upper limbs.The other two weekly sessions were performed at home, following the instructions given by the physiotherapist in session.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • Chronic neck pain (at least 3 months' duration) not related to trauma of at least 3 on a visual analogue scale
  • Participants' symptoms had to be reproduced by median nerve upper-limb neurodynamic test.

You may not qualify if:

  • Whiplash related neck pain
  • Previous cervical surgical intervention
  • Cognitive impairments which prevent them to follow instructions
  • Visual or acoustic limitations
  • Physical therapy in the previous six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences. University of Granada.

Granada, Granada, 18071, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 10, 2018

Study Start

September 1, 2018

Primary Completion

November 1, 2018

Study Completion

February 1, 2019

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations