Condition category
Musculoskeletal Diseases
Date applied
24/05/2017
Date assigned
24/05/2017
Last edited
24/05/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Musculoskeletal disorders (MSD) include different disorders such as osteoarthritis, rheumatoid arthritis, low back pain, neck pain and many more. They account for a large part of global disability and are predicted to increase over the next few years. Recent studies have stated that it is urgent to prevent and control the growth of musculoskeletal disorders by experts in this field; therefore there is a need for changes in the health system and research to understand the management and prevention of such MSD. There is a need to know whether people suffer from a certain “musculo-skeletal” health problem and what tests can be performed by clinicians to detect it in order to direct more research. The aim of this study is to evaluate the accurateness of using a mechanical chiropractic device using different diagnostic tests.

Who can participate?
Adults aged 18 to 70 years old who have a history of back pain.

What does the study involve?
Participants who attend the clinic for back pain undergo two different tests. They first undergo an assessment of their muscles using the modified ankle rigidity test and a leg length inequality test using a motion capture device. They then undergo a chiropractic procedure using a mechanical device that is applied to their neck area. They then repeat the measurements. After this, they undergo an x-ray. The results from the tests are compared to the results from the x-ray to see if the are any differences.

What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating in this study.

Where is the study run from?
1. Centre Quiropràctica Girona (Spain)
2. Gabinet Mèdic de Diagnosi i Tractament: GD mèdic Girona (Spain)

When is the study starting and how long is it expected to run for?
March 2017 to December 2018

Who is funding the study?
Investigator initiated and funded (Spain)

Who is the main contact?
Dr Joaquin Valdivia Tor
migdiaquiro@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joaquin Valdivia Tor

ORCID ID

http://orcid.org/0000-0002-2404-9373

Contact details

Gran Via Jaume I
42
2
2
Girona
17001
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

study protocol

Study information

Scientific title

Prediction of the axial rotation of the atlantooccipital joint by means of the modified manual ankle rigidity test and radiography: Study protocol of a randomized double-blind controlled trial

Acronym

Study hypothesis

The aim of this study is to evaluate the accurateness of the predicted rotational degree set on a mechanical chiropractic device by the main assessor in 50 subjects through the elicited immediate neurophysiological response as measured by one diagnostic test (modified ankle rigidity test) as compared to the radiographic measurement of the atlantooccipital joint. Another diagnostic test (leg length inequality test) is used to assess possible changes in (functional leg discrepancy).

Ethics approval

Not provided at time of registration.

Study design

Randomized prospective double-blind trial of one diagnostic test as primary outcome compared to radiographic measurement outcomes

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Musculo-skeletal

Intervention

Participants consent to participate in the study and have their medical history and physical examination in order to confirm eligibility.

Participants undergo the treatment session. This starts with an assessment of muscle dysfunction using the modified ankle rigidity test, followed by the leg length inequality test with the motion capture device. Next, treatment is applied with the mechanical chiropractic device applied in their neck area according to some specifications and to the criteria of the main assessor. After each application or attempt, the assessor uses the modified ankle rigidity test to evaluate changes. If no changes are observed, a second attempt is carried out and so on. If changes are observed, the assessor stops treatment and performs the leg length inequality test.

After data is recorded, the assessor and the subject go to the X-ray clinic (Gabinet Mèdic de Diagnosi i Tractament)) to take the radiographic view. The assessor is blinded to the results by not seeing the X-ray at any time. They only position the patient, following similar instructions as described for this purpose and the clinic X-ray technician takes the radiograph. The radiographic equipment is regularly aligned by the clinic owners. The results are kept in the X-ray clinic and at the end of the study they are sent to the independent assessor for evaluation. Then, all the results will be sent to the statistician for compilation.

At this point, there is no follow up for participants except for continuing care under main assessor's private clinic if they decide to.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Muscle rigidity is measured using the modified ankle rigidity test and Ashworth scale at baseline and after the treatment.

Secondary outcome measures

1. Leg length discrepancy is measured in sub-millimeters using the leg length inequality test at baseline and after the treatment
2. Degrees of rotation of the atlanto-occipital joint are measured using radiographic views at baseline and after treatment

Overall trial start date

03/03/2017

Overall trial end date

03/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Present or past history of back pain
2. Any gender aged from 18 to 70 years old
3. Consent to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Tumour
2. Spinal fracture
3. Back pain associated with externalized cervical disc herniation
4. Previous back surgery
5. Dizziness and vertigo
6. Spasmodic torticollis
7. Can't sit for more than 30 minutes
8. Received other manual therapies in the previous ten days of the study
9. Under similar care other than the one used in this study in the past.
10. Pregnancy

Recruitment start date

04/01/2018

Recruitment end date

03/10/2018

Locations

Countries of recruitment

Spain

Trial participating centre

Centre Quiropràctica Girona
Gran Via Jaume I 42,2,2
Girona
17001
Spain

Trial participating centre

Gabinet Mèdic de Diagnosi i Tractament: GD mèdic Girona
Plaça josep Pla
Girona
17001
Spain

Sponsor information

Organisation

Joaquin Valdivia

Sponsor details

Gran Via Jaume I
42,2,2
Girona
17001
Spain

Sponsor type

Other

Website

Funders

Funder type

Other

Funder name

Investigator initated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a BioMed Central journal

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository and will be made available from the main assessor, the independent assessor and the statistician.

Intention to publish date

30/06/2017

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes