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

Sponsor

King's College London (Other)

Overall Status

Completed

CT.gov ID

NCT03507920

Collaborator

University of the Basque Country (UPV/EHU) (Other)

Enrollment

Location

Arms

Actual Duration (Months)

13.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Neck Pain	Other: Neck passive mobilizations Other: Manual contact	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 2, 2018

Actual Primary Completion Date :

Jul 2, 2018

Actual Study Completion Date :

Jul 2, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Global rating of change scale [Immediately after the intervention]
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.
Change in pain reported by the participant during neck movements [Baseline and immediately after the intervention]
The participant will be asked to report if he/she has pain on each of the following movements: flexion, extension, side flexion and rotation
Change in Sympathetic nervous system activity using skin conductance [Baseline, during the intervention and immediately after the intervention]
Skin conductance in the index and ring finger will be measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of the Basque Country, Faculty of Medicine and Infirmary	Leioa	Bizkaia	Spain	48940

Sponsors and Collaborators

King's College London
University of the Basque Country (UPV/EHU)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

King's College London

ClinicalTrials.gov Identifier:

NCT03507920

Other Study ID Numbers:

M10/2016/095

First Posted:

Apr 25, 2018

Last Update Posted:

Oct 3, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neck Pain

Study Results

No Results Posted as of Oct 3, 2018