A therapeutic program combining massage and strengthening exercises can correct posture and improve the quality of life in patients with neck pain
| ISRCTN | ISRCTN54231174 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54231174 |
- Submission date
- 18/03/2020
- Registration date
- 19/03/2020
- Last edited
- 20/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
Contact information
Scientific
Psaron 6
Egio
25100
Greece
| Phone | +30 (0)6936767679 |
|---|---|
| kfousekis@upatras.gr |
Study information
| Study design | Single-centre interventional randomized control study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| 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(s) | 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 |
| 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 |
| 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 study start date | 10/09/2019 |
| Overall study end date | 20/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 30 |
| Total final enrolment | 20 |
| Participant inclusion criteria | 1. Female patients with diagnosed mechanical neck pain 2. Craniovertebral angle >50 |
| 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
Study participating centre
Psaron 6
Egio
25100
Greece
Sponsor information
University/education
Psaron 6
Egio
25100
Greece
| Phone | +30 (0)2691022058 |
|---|---|
| physiosecr@upatras.gr | |
| Website | http://physio.upatras.gr/en/ |
"ROR" |
https://ror.org/017wvtq80 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 21/02/2021 | 20/08/2021 | Yes | No |
Editorial Notes
20/08/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
19/03/2020: Trial's existence confirmed by University of Patras.
