Condition category
Musculoskeletal Diseases
Date applied
06/12/2015
Date assigned
16/12/2015
Last edited
16/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Neck pain is a very common problem which affects more than two thirds of people at some point in their lives. Non-specific chronic neck pain is where the sufferer has been affected for at least 3 months, and no obvious cause can be identified. It has been found that in people suffering from chronic neck pain, sufferers often avoid movement for fear that it will make the pain worse (kinesiophobia). Studies have shown that when a person with a long-term pain condition is suffering from kinesiophobia, they are likely to experience disability to a greater extent, as lack of movement can make their condition worse. Cognitive behavioural therapy (CBT) is a type of taking therapy which aims to help people to manage their problems by changing the way they think and behave. The aim of this study is to find out taking part in a programme combining CBT with specific exercises designed for people suffering from chronic neck pain can help to reduce pain and disability in the short- and long-term, compared to exercises alone.

Who can participate?
Adults suffering from non-specific chronic neck pain.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group take part in a 10 week course with two experienced physiotherapists involving a range of different exercises designed to help reduce pain and increase range of movement in the neck. Participants in this group also receive 10 hour-long sessions of CBT with a trained psychologist, aiming to help to reduce their fear of movement. Participants in the second group take part in a 10 week course of general physiotherapy for the neck, involving muscle strengthening, stretching exercises and gentle movements designed to help the range of movement in the spine (spinal mobilization). These sessions last for one-hour and are delivered to groups of 5 patients at a time by two experienced physiotherapists. At the start of the study, after the 10-week exercise programme and 12 months later, participants in both groups complete a number of questionnaires to find out if there has been any change to their pain levels, or neck pain-related disability.

What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their pain levels and disability as a result of taking part in the exercise programs. Additionally, participants may benefit from an improvement to their overall quality of life. There are no notable risks expected for those taking part in the study.

Where is the study run from?
Institute Of Hospitalization and Care Scientific (Italy)

When is the study starting and how long is it expected to run for?
January 2010 to December 2013

Who is funding the study?
Institute Of Hospitalization and Care Scientific (Italy)

Who is the main contact?
Dr Marco Monticone

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marco Monticone

ORCID ID

Contact details

Istituto Di Ricovero e Cura a Carattere Scientifico
Via Monsignor Bernasconi 16
Lissone
20851
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Group-based multimodal exercises integrated with cognitive-behavioural therapy improve disability, pain and quality of life of subjects with chronic neck pain: A randomized controlled trial with one-year follow-up

Acronym

Study hypothesis

A 10-week rehabilitation programme of group-based multimodal exercises integrated with CBT mainly aimed at managing fear of movement would induce clinically significant improvements in disability, pain, and quality of life in subjects with chronic neck pain vs. group-based general physiotherapy, and that these would be maintained in the long term.

Ethics approval

Institutional Review Board of the Scientific Institute of Lissone of the Salvatore Maugeri Foundation, 03/12/2009, ref: 8

Study design

Randomized parallel-group superiority-controlled trial

Primary study design

Interventional

Secondary study design

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Chronic neck pain

Intervention

Participants are randomly allocated to one of two groups.

Experimental Group: Participants complete 10 hour-long group-based multimodal exercises for the neck, including cervical mobility, postural control, strengthening muscles, and stretching the neck in groups of 5. Patients specifically learn stabilizing techniques for deep neck muscles, progressively increasing the speed and complexity of the movements. Participants in this group also receive 10 hour-long sessions with a trained psychologist, in which they receive cognitive behavioural therapy (aimed at modifying fear of movement beliefs, and ensuring gradual reactions to illness behaviours) in groups of 5.

Control Group: Participants complete 10 hour-long group-based general physiotherapy for the neck, involving muscle strengthening, segmentary stretching and spinal mobilisation, in groups of 5 patients.

Interventions are delivered by a psychologist and two equally-experienced physiotherapists, separately responsible for the experimental and the control group. The exercise programme is planned individually by the physiotherapists based on a physical examination of each participant, consisting of postural observation, cervical range of motion examination, manual muscle testing, muscle length assessment, deep neck flexors endurance examination. Ergonomic advice is provided during the first session in order to facilitate the modification of daily living activities. A fidelity check, based on a treatment manual for exercise administration, is also conducted at the end of each session.

In both groups, during the treatment period, the questionnaires are administered by secretaries who checked them and returned any uncompleted part to the patients for completion. At follow-up, the patients are asked to return to the Institute or are contacted by phone by the same secretaries in order to repeat the questionnaires.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Extent of neck-pain related disability is measured using the Neck Disability Index (NDI) at baseline, 10 weeks and 12 months.

Secondary outcome measures

1. Fear of movement is measured using the Tampa Scale for Kinesiophobia at baseline, 10 weeks and 12 months
2. Pain is measured using the Pain Catastrophizing Scale and Pain Numerical Rating Scale at baseline, 10 weeks and 12 months
3. Health outcomes are measured using the Short-Form Health Survey at baseline, 10 weeks and 12 months

Overall trial start date

01/01/2010

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. A diagnosis of non-specific chronic neck pain (i.e. a documented history of pain lasting more than 3 months
3. A good understanding of Italian

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

154

Participant exclusion criteria

1. Acute and subacute neck pain
2. Cognitive impairment
3. All causes of specific neck pain such as previous spinal surgery, deformity, disc herniation, infection, fracture, myelopathy or malignancy, whiplash injuries, and systemic or neuromuscular diseases
4. Previously received cognitive behavioural therapy

Recruitment start date

01/01/2010

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Italy

Trial participating centre

Istituto Di Ricovero e Cura a Carattere Scientifico
Physical Medicine and Rehabilitation Unit Scientific Institute of Lissone Salvatore Maugeri Foundation Institute of Care and Research Via Monsignor Bernasconi 16
Lissone
20851
Italy

Sponsor information

Organisation

Istituto Di Ricovero e Cura a Carattere Scientifico

Sponsor details

Physical Medicine and Rehabilitation Unit
Scientific Institute of Lissone
Salvatore Maugeri Foundation
Institute of Care and Research
Via Monsignor Bernasconi 16
Lissone
20851
Italy

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Institute Of Hospitalization and Care Scientific (Istituto Di Ricovero e Cura a Carattere Scientifico)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of results in international Journals in the field of Physical Medicine and Rehabilitation.

Intention to publish date

30/06/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes