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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/27012824