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

Primary Purpose

Neck Pain

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Neck passive mobilizations

Manual contact

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of the Basque Country, Faculty of Medicine and Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Neck passive mobilizations

Manual contact

Arm Description

Outcomes

Primary Outcome Measures

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.

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

Change in Sympathetic nervous system activity using skin conductance

Skin conductance in the index and ring finger will be measured

Secondary Outcome Measures

Full Information

NCT ID

NCT03507920

First Posted

April 9, 2018

Last Updated

October 2, 2018

Sponsor

King's College London

Collaborators

University of the Basque Country (UPV/EHU)

1. Study Identification

Unique Protocol Identification Number

NCT03507920

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

April 2, 2018 (Actual)

Primary Completion Date

July 2, 2018 (Actual)

Study Completion Date

July 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

King's College London

Collaborators

University of the Basque Country (UPV/EHU)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neck Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neck passive mobilizations

Arm Type

Experimental

Arm Title

Manual contact

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

Neck passive mobilizations

Intervention Description

Passive mobilizations performed to the neck of the participant by a Physiotherapist

Intervention Type

Other

Intervention Name(s)

Manual contact

Intervention Description

Manual contact applied to the neck of the participant by a Physiotherapist

Primary Outcome Measure Information:

Title

Global rating of change scale

Description

Time Frame

Immediately after the intervention

Title

Change in pain reported by the participant during neck movements

Description

The participant will be asked to report if he/she has pain on each of the following movements: flexion, extension, side flexion and rotation

Time Frame

Baseline and immediately after the intervention

Title

Change in Sympathetic nervous system activity using skin conductance

Description

Skin conductance in the index and ring finger will be measured

Time Frame

Baseline, during the intervention and immediately after the intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of the Basque Country, Faculty of Medicine and Infirmary

City

Leioa

State/Province

Bizkaia

ZIP/Postal Code

48940

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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