Condition category
Musculoskeletal Diseases
Date applied
20/06/2014
Date assigned
25/07/2014
Last edited
29/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Skeletal muscles (muscles that are under our control, allowing us, for example, to move and maintain our posture) are electrically active, and the signals measured from skeletal muscle cells can be used to detect medical problems. When we are resting, our skeletal muscles are normally electrically inactive, but pain can cause an increase in electrical activity. This activity can be measured using an instrument called an electromyograph. This study will use an electromyograph to find out how well a new spinal manipulation technique developed for relieving pain in thoracic spine muscles (muscles in the middle of your back) performs compared to an established manipulation technique. If the new technique results in greater pain relief than the conventional treatment, the electromyograph will record less electrical activity.

Who can participate?
Participants aged between 18 and 30 with acute or chronic pain in their thoracic spine muscles.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in group 1 undergo the new spinal manipulation technique. Group 2 are treated using the established technique. Pain and tenderness felt by each participant and the electromyography activity of their thoracic spine muscles are measured before treatment begins, immediately after the treatment and a week after treatment.

What are the possible benefits and risks of participating?
Not provided at registration

Where is the study run from?
Alcalá University (Spain)

When is the study starting and how long is it expected to run for?
July 2014 to October 2014

Who is funding the study?
Alcalá University (Spain)

Who is the main contact?
Dr Daniel Pecos-Martin
daniel.pecos@uah.es

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Pecos-Martin

ORCID ID

Contact details

Departamento de Enfermería y Fisioterapia
Universidad de Alcalá
Alcalá de Henares
28871
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Manual therapy effects on the electromyographic activity of the thoracic erector spinal muscles

Acronym

Study hypothesis

An anterior/posterior articular manipulation technique on the thoracic spine produces better changes in electromyography activity and the pain related with erector spinal muscle.

Ethics approval

Alcalá ethics committee, 3/2/2014, ref. M2013/044/20140131

Study design

Single-blind randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Subjects with localized pain in the thoracic region of the back. Musculoskeletal pain related to activity.

Intervention

1. Experimental group: application of a PA contact mobilization using the T7 vertebra pisiforme about 3 minutes, with 20 seconds interval, with a frequency of 1 to 2 Hz. The mobilization amplitude grade III was applied.
2. Placebo group: application of a PA contact mobilization using the T7 vertebra pisiforme about 3 minutes, with 20 seconds interval, with a frequency of 1 to 2 Hz. The mobilization to a lower grade was applied as described by Maitland

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Electromyography activity of thoracic spine muscles

Secondary outcome measures

Pain in thoracic spine muscles

The primary and secondary outcomes will be measured before treatment, immediately after and, finally, a week later.
Instruments used:
1. Pain: VAS
2. Tenderness: Algometry
3. Muscle activity: superficial electromyography

Overall trial start date

01/07/2014

Overall trial end date

01/10/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Acute or chronic pain in the thoracic spine of nonspecific origin
2. Aged 18 to 30 years
3. Body Mass Index (BMI) < 29

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

42

Participant exclusion criteria

1. Previous history of surgery
2. Cardiovascular disorders
3. Neurological, musculoskeletal, osteoporosis, tumor, cancer diseases, radicular pain and / or neuropathy

Recruitment start date

01/07/2014

Recruitment end date

01/10/2014

Locations

Countries of recruitment

Spain

Trial participating centre

Universidad de Alcalá
Alcalá de Henares
28871
Spain

Sponsor information

Organisation

Alcalá University (Spain)

Sponsor details

Campus Externo
S/N
Crta. Madrid - Barcelona
km 33,600
Facultad de Fisioterapia
Att: Daniel Pecos-Martin
Alalá de Henares
28871
Spain

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Alcalá University (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/27012824

Publication citations

Additional files

Editorial Notes

29/03/2016: Publication reference added.