Condition category
Signs and Symptoms
Date applied
16/07/2016
Date assigned
20/07/2016
Last edited
20/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Long-term pain in the neck/shoulder/upper back region is very common in people of all ages. It is especially common, even in young people, who take part in desk-based work and little physical exercise. The main reason for this is thought to be because of poor posture, which causes certain muscles to become overworked and others to be underused. This imbalance causes tightness in the overworked muscles and weakness in the underused ones. Over time, this creates discomfort during activity and thereby reduces daily activities. Traditionally, back and neck problems are treated separately, rather than working on the upper body as a whole. The back and neck are physically connected and so a problem that occurs in the upper back can lead to changes in the shoulders and neck. Stretching muscle groups is important for ensuring that underused muscles gain strength and overworked muscles relax, but there are different techniques for doing this. The aim of this study is to compare two stretching-based exercise programmes to find out whether they are able to improve function.

Who can participate?
Adults aged between 25 and 50 who have discomfort in the neck/shoulder/upper back region.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in an exercise programme which involves passive stretching of muscles (where the physiotherapist moves the body to cause the stretch) in order to improve the strength of lesser used muscles and increasing endurance of the deep neck muscles, as well as relaxed deep breathing exercises. Those in the second group take part in a conventional exercise programme which involves active stretching (where the participant stretches themselves) with deep breathing exercises. For both groups, sessions take place three times a week for eight weeks and last around 45 minutes each. Participants in both groups are examined at the start of the study and then again after 8 and 12 weeks to find out if their has been any improvement to their functioning.

What are the possible benefits and risks of participating?
All participants benefit from having a physical therapist examine their shoulder/neck/upper back region, which gives them information about what is causing their discomfort. Participants who take part in the exercise programme benefit from strengthening their muscles which could help to reduce tension in tight muscles, lessening pain and improving function. There are no notable risks involved with participating in this study.

Where is the study run from?
Mohamed Sathak AJ College of Physiotherapy (India)

When is the study starting and how long is it expected to run for?
February 2014 to August 2017

Who is funding the study?
Mohamed Sathak AJ College of Physiotherapy (India)

Who is the main contact?
Professor Purushothaman Senthil

Trial website

Contact information

Type

Scientific

Primary contact

Prof Purushothaman Senthil

ORCID ID

http://orcid.org/0000-0002-0472-0043

Contact details

5/738
G2
J.R. Nilayam
Vignarajapuram 3rd extn
Santhosapuram
Chennai
600073
India

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of corrective exercise strategy on upper body dysfunction

Acronym

UBD

Study hypothesis

Corrective exercise is better than conventional exercise on upper body dysfunction.

Ethics approval

Doctoral ethical committee, School of Physiotherapy, Vel's University, 28/08/2015, ref: EC/PHD/14/FEB/PHY/001

Study design

Single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

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

Condition

Shoulder/neck/upper back dysfunction

Intervention

Participants are randomised to one of two groups.

Experimental group: Participants undergo passive stretching of overactive muscles and graded strengthening of underactive muscles and training deep cervical flexors endurance and relaxed diaphragm breathing exercises.

Control group: Participants undergo conventional exercise of active stretching of overactive and free exercise and isometric exercise to underactive muscles with diaphragm breathing exercises.

For both groups, sessions last 45 minutes and take place three times a week for a total of eight weeks.

Participants in both groups are followed up at 8 and 12 weeks.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Functionality is measured using Patient specific functional scale at baseline, 8 and 12 weeks.

Secondary outcome measures

1. Postural analysis is conducted using Posture Pro 8 software with Photo-imaging of participants at baseline, 8 and 12 weeks
2. Scapula-humeral muscle strength is measured using the Push-Pull dynamometer (150 lb type) at baseline, 8 and 12 weeks
3. Deep cervical flexors endurance is measured using a biofeedback unit at baseline, 8 and 12 weeks

Overall trial start date

02/02/2014

Overall trial end date

30/08/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient with discomfort in the neck/shoulder/upper back region
2. Aged 25 to 50 years
3. Degeneration cervical spine

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Control (n) - 65; experimental (n) - 65.

Participant exclusion criteria

1. Patients with cervical disc diseases
2. Infection of neck/shoulder joints
3. Malignancy over the above region
4. Recent injuries/fractures over the above region

Recruitment start date

01/08/2015

Recruitment end date

01/02/2017

Locations

Countries of recruitment

India

Trial participating centre

Mohamed Sathak AJ College of Physiotherapy
144/1, Nungambakkam High Road Nungambakkam
Chennai
600034
India

Sponsor information

Organisation

Mohamed Sathak AJ College of Physiotherapy

Sponsor details

144/1
Nungambakkam High Road
Nungambakkam
Chennai
600034
India

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Mohamed Sathak AJ College of Physiotherapy

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publications in peer reviewed journals in the following areas:
1. Isolated activation of middle Trapezieus in subjects with protracted shoulder
2. Prevalence of the postural scapular dysfunction and corrective exercise training in school going children
3. Inter-reliability of posture analysis software in subjects with Kyphotic changes

Intention to publish date

30/01/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes