Active Intervention for Patients With Neck Pain
Effects of an Active Program in Patients With Chronic Neck Pain: a Randomized Controlled Trial.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2019
Shorter than P25 for not_applicable
1 active site
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
June 11, 2019
CompletedStudy Start
First participant enrolled
June 11, 2019
CompletedFirst Posted
Study publicly available on registry
June 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2019
CompletedSeptember 4, 2019
August 1, 2019
2 months
June 11, 2019
August 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in number of active trigger points
Baseline, 4 weeks
Changes from baseline to 4 weeks in the number of active trigger points assessed by palpation. The percentage of active trigger points is obtained.
Secondary Outcomes (2)
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).
Study Arms (2)
Active intervention
EXPERIMENTALPatients will be included in an active intervention.
Control group
NO INTERVENTIONPatients in the control group will not receive any intervention
Interventions
Patients allocated to the experimental group were included in an active exercising program adapted to each patient
Eligibility Criteria
You may qualify if:
- 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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physical Therapy
Granada, 18071, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
June 11, 2019
First Posted
June 17, 2019
Study Start
June 11, 2019
Primary Completion
August 11, 2019
Study Completion
September 11, 2019
Last Updated
September 4, 2019
Record last verified: 2019-08