Condition category
Musculoskeletal Diseases
Date applied
28/11/2016
Date assigned
06/12/2016
Last edited
19/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The spine is made up of a series of small bones called vertebrae. Scoliosis is a condition that causes the vertebrae to twist or rotate, causing the spine to curve sideways. There are several different types of scoliosis, however the most common type is known as “idiopathic”, which means that the exact cause is not known. Despite years of research, the mechanisms behind disease progression in scoliosis are unknown. In many patients, the only way to effectively treat the condition is surgically. Scientists are looking for the most effective treatment of scoliosis in children to avoid surgery. Physiotherapy is one of important elements of conservative treatment. Proprioceptive Neuromuscular Facilitation (PNF) is one of the techniques used in patients with various structural and motor (movement) problems. Previous studies showed a more limited range of spine rotation on one side of the body in scoliotic girls compared to girls without scoliosis. The differences were observed especially in girls with double, i.e. “S” shaped scoliosis. The aim of this study is to investigate the effectiveness of one-sided PNF rotational mobilisation in girls with double idiopathic scoliosis.

Who can participate?
Girls aged between 10 and 17 who have double idiopathic scoliosis

What does the study involve?
All participants undergo one sided PNF mobilisation. This takes place when the participants are lying down with their lower body turned. Mobilization consists of lower limb movement patterns combined with a relaxation technique and irregular breathing. The mobilization lasts for a total of approximately three minutes. Before and after the mobilisation, participants have the amount they are able to turn their body (trunk rotation) measured as well as their range of movement.

What are the possible benefits and risks of participating?
Participants may benefit from increased range of motion in their spine. There are no notable risks involved with participating.

Where is the study run from?
1. Center of Functional Rehabilitation ORTHOS, Warsaw (Poland)
2. Regional Children’s Hospital, Jastrzębie Zdrój (Poland)
3. Children's Memorial Health Institute, Warsaw (Poland)

When is the study starting and how long is it expected to run for?
December 2014 to March 2016

Who is funding the study?
Investigator initiated and funded (Poland)

Who is the main contact?
Dr Agnieszka Stępień
orthosas@wp.pl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Agnieszka Stępień

ORCID ID

http://orcid.org/0000-0003-3905-8229

Contact details

Józef Piłsudski University of Physical Education
Marymoncka 34
Warsaw
00-968
Poland
+48 (0)60 263 0627
orthosas@wp.pl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1/2016

Study information

Scientific title

The immediate effect of PNF specific mobilization on the angle of trunk rotation and Trunk-Pelvis-Hip Angle range of motion in adolescent girls with idiopathic scoliosis – a pilot study

Acronym

PNF ATR TPHA

Study hypothesis

Single unilateral muscle PNF mobilization, using bilateral leg patterns combined with contract – relax technique and asymmetrical breathing, decreases values angle of trunk rotation and increases range of rotation in the trunk- pelvis- hip complex.

Ethics approval

The Senate Research Ethics Committee at Józef Piłsudski University of Physical Education, 17/02/2015, ref: SKE 01-04/2015

Study design

Multi-centre non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Idiopathic scoliosis

Intervention

After the first assessment of the participant, a unilateral PNF specific mobilization is performed in a supine position with a stable chest, flexed lower limbs and rotated lower trunk. The total duration of mobilization is approximately three minutes. PNF - bilateral lower extremity patterns (flexion to the right and extension to the left) are used in combination with “contract-relax” technique and stimulation of asymmetrical breathing. Three cycles of three isometric contractions against resistance for 5 seconds and active increased range of motion are applied. Next participants perform ten active movements of lower extremities – bilateral flexion to the right with a stable chest. The last phase of mobilization involves asymmetrical breathing, i.e. 5 slow inspirations and expirations. An angle of trunk rotation in the thoracic and lumbar spine and range of rotation in the trunk-pelvis-hip complex are measured as re-assessment.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Angle of trunk rotation (ATR) is meausred with a scoliometer at baseline and after mobilization

Secondary outcome measures

Active range of movement in the trunk-pelvis-hip complex in transverse plane is measured with a Rippstein plurimeter at baseline and after mobilization.

Overall trial start date

01/12/2014

Overall trial end date

31/03/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female
2. Age 10-17 years
3. Double idiopathic scoliosis with a right-sided thoracic curve and a left-sided lumbar/thoracolumbar curve diagnosed on antero-posterior radiogram
4. Absence of systemic diseases

Participant type

Patient

Age group

Child

Gender

Female

Target number of participants

83

Participant exclusion criteria

1. Other than idiopathic type of scoliosis
2. A spinal curvature with a Cobb angle of less than 10 degrees
3. Pain
4. A history of traumatic injury

Recruitment start date

15/03/2015

Recruitment end date

15/09/2015

Locations

Countries of recruitment

Poland

Trial participating centre

Center of Functional Rehabilitation ORTHOS
Modzelewskiego 37
Warsaw
02-679
Poland

Trial participating centre

Regional Children’s Hospital
ul. Krasickiego 21
Jastrzębie Zdrój
44-335
Poland

Trial participating centre

Children's Memorial Health Institute
ul. Aleja Dzieci Polskich 20
Warsaw
04-730
Poland

Sponsor information

Organisation

Józef Piłsudski University of Physical Education

Sponsor details

Marymoncka 34
Warsaw
00-968
Poland

Sponsor type

University/education

Website

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 paper will be published in an orthopedic, physical therapy or rehabilitation journal.

IPD Sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

30/06/2017

Participant level data

Other

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28905003

Publication citations

Additional files

Editorial Notes

19/10/2017: Publication reference added.