Effects of manual therapy for thoracic muscle pain

ISRCTN	ISRCTN47601528
DOI	https://doi.org/10.1186/ISRCTN47601528
Protocol serial number	N/A
Sponsor	Alcalá University (Spain)
Funder	Alcalá University (Spain)

Submission date: 20/06/2014
Registration date: 25/07/2014
Last edited: 29/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Daniel Pecos-Martin
Scientific

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

Study information

Primary study design	Interventional
Study design	Single-blind randomized clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Manual therapy effects on the electromyographic activity of the thoracic erector spinal muscles
Study objectives	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(s)	Alcalá ethics committee, 3/2/2014, ref. M2013/044/20140131
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Electromyography activity of thoracic spine muscles
Key secondary outcome measure(s)	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
Completion date	01/10/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	42
Key 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
Key exclusion criteria	1. Previous history of surgery 2. Cardiovascular disorders 3. Neurological, musculoskeletal, osteoporosis, tumor, cancer diseases, radicular pain and / or neuropathy
Date of first enrolment	01/07/2014
Date of final enrolment	01/10/2014

Locations

Countries of recruitment

Spain

Study participating centre

Universidad de Alcalá

Alcalá de Henares
28871
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

29/03/2016: Publication reference added.