The Effects of Spinal Mobilizations on Neck Pain and Sympathetic Nervous System Activity in People With Neck Pain

This study investigates the effects of spinal mobilizations on neck symptoms and sympathetic nervous system activity in people with neck pain.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: Neck passive mobilizations; Other: Manual contact

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Bizkaia
    • Leioa, Bizkaia, Spain, 48940
      • University of the Basque Country, Faculty of Medicine and Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary complaint of neck pain
• Non-traumatic history of onset
• Pain has a clear mechanical aggravating and easing positions or movements
• Limited range of motion
• Local provocation tests produce recognisable symptoms
• A positive expectation that mobilisations will help

Exclusion Criteria:

• No neurological deficit
• No signs of central hyperexcitability
• Referral to other health professional to exclude red flags not required

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neck passive mobilizations	Other: Neck passive mobilizations; Passive mobilizations performed to the neck of the participant by a Physiotherapist
Placebo Comparator: Manual contact	Other: Manual contact; Manual contact applied to the neck of the participant by a Physiotherapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global rating of change scale	Measures overall improvement as perceived by the participant. It is a 15-point scale ranging from -7 (a very great deal worse), through 0 (no change), to +7 (a great deal better). Values above 0 denote improvement following treatment, 0 denotes no change, and values below 0 denote worsening after the treatment. The higher the value, the greater the improvement; the lower the value, the greater the worsening. The participant will be asked to provide a value that represents their change (they may give 0, which denotes no change) following the intervention.	Immediately after the intervention
Change in pain reported by the participant during neck movements	The participant will be asked to report if he/she has pain on each of the following movements: flexion, extension, side flexion and rotation	Baseline and immediately after the intervention
Change in Sympathetic nervous system activity using skin conductance	Skin conductance in the index and ring finger will be measured	Baseline, during the intervention and immediately after the intervention

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: University of the Basque Country (UPV/EHU)

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Actual): July 2, 2018
• Study Completion (Actual): July 2, 2018

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 2, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: M10/2016/095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No