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Clinical Trials/NCT03987516
NCT03987516UnknownNot Applicable

Effects of an Active Program in Patients With Chronic Neck Pain: a Randomized Controlled Trial.

Universidad de Granada1 site in 1 country50 target enrollmentStarted: June 11, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
50
Locations
1
Primary Endpoint
Changes in number of active trigger points

Study Overview

Brief Summary

Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck movements or sustained neck postures. More than 80 % of individuals experience neck pain and neck associated disorders. The aim of this study was to investigate the effects of a 4-week active exercising program in patients with chronic neck pain.

Detailed Description

While neck pain can be severely disabling and costly, treatment options have shown moderate evidence of effectiveness. The optimal physiotherapy intervention is currently unclear. Consequently, more research in this area combining different techniques in patients with a specific clinical profile is needed. It has been previously shown that participants prefer self-care measures for the management of neck pain. The aim of this study was to investigate the effects of a 4-week active exercising program in patients with chronic neck pain.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •To suffer from chronic neck pain (at least 3 months' duration)
  • •Neck pain of at least 3 on a visual analogue scale.
  • •Participants' symptoms should be at least partly related to increased nerve mechanosensitivity in the neck and upper limb confirmed by the reproduction of participants' symptoms by median nerve upper-limb neurodynamic test.

Exclusion Criteria

  • •Whiplash related neck pain.
  • •Previous cervical surgical intervention.
  • •Cognitive impairments which prevent them to follow instructions.
  • •Visual or acoustic limitations.

Arms & Interventions

Active intervention

Experimental

Patients will be included in an active intervention.

Intervention: Active exercising (Other)

Control group

No Intervention

Patients in the control group will not receive any intervention

Outcomes

Primary Outcomes

Changes in number of active trigger points

Time Frame: Changes from baseline to 4 weeks in the number of active trigger points assessed by palpation. The percentage of active trigger points is obtained.

Baseline, 4 weeks

Secondary Outcomes

  • Severity of pain(Changes from baseline to 4 weeks in the severity of pain assessed using the Brief Pain Inventory. The severity and the interference of pain with daily life subscales were included. Score is the sum of the items divided by the number of items.)
  • Functionality(Changes from baseline to 4 weeks on functionality assessed using the Neck Outcome Score.Symptoms, sleep disturbance, every day activity and pain and participation in everyday life subscales were included. They Ranged from 0 to 100 (no simptoms).)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marie Carmen Valenza

Principal Investigator

Universidad de Granada

Study Sites (1)

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