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

NCT03507920 | Completed DMC

• 1 other identifier: M10/2016/095
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Neck passive mobilizations

EXPERIMENTAL

Other: Neck passive mobilizations

Manual contact

PLACEBO COMPARATOR

Other: Manual contact

Interventions

Neck passive mobilizations OTHER

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

Neck passive mobilizations

Manual contact OTHER

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

Manual contact

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

University of the Basque Country, Faculty of Medicine and Infirmary

Leioa, Bizkaia, 48940, Spain

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 25, 2018
• Study Start: April 2, 2018
• Primary Completion: July 2, 2018
• Study Completion: July 2, 2018
• Last Updated: October 3, 2018

Record last verified: 2018-04

Locations

ES (1)