Condition category
Musculoskeletal Diseases
Date applied
18/03/2020
Date assigned
19/03/2020
Last edited
19/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Postural disorders like forward head posture (FHP) have been linked to cervical dysfunction and pain in patients with neck pain syndromes. Nevertheless, it remains unclear whether this can be corrected by specific therapeutic programs. The aim of this study is to evaluate the short- and long-term effects of the combined application of massage, soft-tissue stretching and strengthening exercises of the cervical and thoracic area of the spine on the improvement of quality of life in neck pain patients.

Who can participate?
Female patients with neck pain

What does the study involve?
Participants are randomly allocated to receive specific exercises combined with either targeted IASTM (instrument-assisted soft tissue mobilization) or classical massage for eight treatment sessions in 4 weeks (twice per week). The total duration of the follow-up is 2 months (8 weeks).

What are the possible benefits and risks of participating?
Benefits of the study include improvement of functionality in terms of strength, mobility, and disability. There is no risk for the patients because the procedures are light (massage-soft tissue techniques) and therapeutic (exercises).

Where is the study run from?
University of Patras (Greece)

When is the study starting and how long is it expected to run for?
September 2019 to June 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Konstantinos Fousekis
kfousekis@upatras.gr

Trial website

Contact information

Type

Scientific

Primary contact

Dr Konstantinos Fousekis

ORCID ID

Contact details

Psaron 6
Egio
25100
Greece
+30 (0)6936767679
kfousekis@upatras.gr

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

A structured rehabilitation program combining targeted instrument-assisted soft tissues mobilization (IASTM) applications and neuromuscular exercises can correct forward head posture and improve functionality of patients with mechanical neck pain

Acronym

Study hypothesis

The main study hypothesis is that the combined application of instrument-assisted soft tissues mobilization (IASTM) techniques and neuromuscular exercises of the cervical and thoracic area is better than the combined application of classical massage and same exercises on the improvement of the functionality of patients with mechanical neck pain.

Ethics approval

Approved 10/11/2019, ethical committee of the Department of Physiotherapy, University of Patras (Dr Charalambos Matzaroglou MD, Psaron 6, Egio PC 25100, Greece; +30 (0)26910 22058; orthopatras@yahoo.gr), ref: 29-10/11/2019

Study design

Single-centre interventional randomized control study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Mechanical neck pain

Intervention

Randomization of the patients will be performed before assessment by computer-generated numbers, details of which will be concealed in sequentially numbered, sealed opaque envelopes.

20 female patients with diagnosed mechanical neck pain and FHP (>50) are randomized to receive specific exercises combined with either targeted IASTM applications (group A, n=10) or classical massage (Group B, n=10) for 8 treatment sessions in 4 weeks (2 x week).

The total duration of the follow-up will be 2 months (8 weeks).

Intervention type

Other

Phase

Drug names

Primary outcome measure

Forward head posture in sitting and standing, measured by craniospinal angle measurement (Cervicalangle or Craniovertebralangle - CVA) before and after each treatment session and at 2 and 4 weeks after the end of treatment

Secondary outcome measures

Measured during treatment (before and after each treatment session) and at 2 and 4 weeks after the end of treatment:
1. Pain measured using the VAScale pain questionnaire
2. Cervical muscles strength measured using the Microfet 2 hand dynamometer
3. Cervical range of motion (ROM) measured using inclinometer (BubbleInclinometerBaseline)
4. Neck disability assessed using neck pain disability index (NDI) questionnaire

Overall trial start date

10/09/2019

Overall trial end date

20/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Female patients with diagnosed mechanical neck pain
2. Craniovertebral angle >50

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

30

Participant exclusion criteria

1. Little or no forward head displacement (<50°)
2. Acute neck injuries
3. Intervertebral disc herniations
4. Vertebral slip
5. Concomitant neurological, musculoskeletal, and mental disorders
6. Medication administration

Recruitment start date

10/01/2020

Recruitment end date

15/02/2020

Locations

Countries of recruitment

Greece

Trial participating centre

University of Patras
Lab of human assessment and rehabilitation Psaron 6
Egio
25100
Greece

Sponsor information

Organisation

University of Patras

Sponsor details

Psaron 6
Egio
25100
Greece
+30 (0)2691022058
physiosecr@upatras.gr

Sponsor type

University/education

Website

http://physio.upatras.gr/en/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers are intending to publish their results in a top-class scientific journal by the end of August 2020.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be available upon request from Dr Konstantinos Fousekis (kfousekis@upatras.gr) after the end of the study.

Intention to publish date

01/08/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/03/2020: Trial's existence confirmed by University of Patras.