Effects of manual therapy for thoracic muscle pain
| ISRCTN | ISRCTN47601528 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47601528 |
| Secondary identifying numbers | N/A |
- 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
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
Scientific
Departamento de Enfermería y Fisioterapia
Universidad de Alcalá
Alcalá de Henares
28871
Spain
Study information
| Study design | Single-blind randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/07/2014 |
| Completion date | 01/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
28871
Spain
Sponsor information
University/education
Campus Externo, S/N
Crta. Madrid - Barcelona, km 33,600
Facultad de Fisioterapia
Att: Daniel Pecos-Martin
Alalá de Henares
28871
Spain
"ROR" |
https://ror.org/04pmn0e78 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
29/03/2016: Publication reference added.
