Low Back PainNCT03794830
The Influence of the Manipulation of the Sacroiliac Joint on Low Back Pain
A study testing manipulation group (MG) and electrotheraphy group (EG) in people with Low Back Pain and Sacroiliac Disorder, run by University of Extremadura at 1 site in Spain.
Trial summary
The primary focus of this study is to know the influence of sacroiliac joint manipulation on low back pain with or without radiation to lower limbs, in the lumbopelvic-hip joint Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Sacroiliac Disorder
- What is being tested?
- manipulation group (MG) and electrotheraphy group (EG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteSpain
- Study dates
- 4 Dec 2018to 4 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- dysfunction or sacroiliac joint hypomobility (SI)
- having stopped taking anti-inflammatory medicines or analgesics three days before the study began
Who cannot join
- destructive injuries of the spine and pelvis
- fractures
- lumbar surgery
- sacroiliac instability
- spondylolisthesis
- pregnancy in progress
Show all 12Show fewer
- cauda equina syndrome
- abdominal aneurysm
- infection
- inflammatory arthritis
- tumors
- osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of the Manipulation of the Sacroiliac Joint on Low Back Pain With or Without Radiation to Lower Limbs
The primary focus of this study is to know the influence of sacroiliac joint manipulation on low back pain with or without radiation to lower limbs, in the lumbopelvic-hip joint
Read the detailed description
One of the main problems faced by physiotherapists in primary care is low back pain with or without radiation to lower limbs. Nowadays, there are a lot of types of low back pain interventions, yet despite the vast amount of research findings, the evidence remains contradictory and inconclusive: Pharmacological treatments like NSAIDs have shown result in acute low back pain but not in chronic pain; conservative interventions (ultrasound, interferential currents, mechanical traction and massage) have been studied and found ineffective.
A total of 151 low back pain patients with or without radiation to lower limbs between 18-70 years old derived from the Physiotherapy Unit of Gévora Health Center (Badajoz, Spain) voluntarily entered the study
- Conditions
- Low Back Pain, Sacroiliac Disorder
- Being tested
- manipulation group (MG), electrotheraphy group (EG)
- Keywords
- sacroiliac joint, low back pain, Osteopathic manipulation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manipulation group (MG)Other
Patients were treated with sacroiliac joint osteopathic semidirect manipulation twice a week every 3 to 4 days over a period of time of 3 weeks
electrotheraphy group (EG)Other
Patients were treated with micro-waves (circular antenna in lumbar area, pulsating-mode 120W for 12 minutes) and later conventional analgesic TENS (80Hz frequency, 30 minutes) 5 days per week over a period of time of 3 weeks (15 sessions)
| Study group | Role | What they receive |
|---|---|---|
| manipulation group (MG) | Experimental | Patients were treated with sacroiliac joint osteopathic semidirect manipulation twice a week every 3 to 4 days over a period of time of 3 weeks Receives: Other: manipulation group (MG) |
| electrotherapy group (EG) | Active comparator | Patients were treated with micro-waves (circular antenna in lumbar area, pulsating-mode 120W for 12 minutes) and later conventional analgesic TENS (80Hz frequency, 30 minutes) 5 days per week over a period of time of 3 weeks (15 sessions of electrotherapy). Receives: Other: electrotheraphy group (EG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS)
Pain assessment from 0 to 10. 0: no pain 10: maximum pain
Measured: 1 week
Oswestry disability index (ODI)
disability assessment 0% -20% (Minimum Disability) 21% -40% (Moderate disability) 41% -60% (Severe disability) 61% -100% (Disabled):
Measured: 1 week
Roland Morris questionnaire
disability assessment The extreme values oscillate between 0 (absence of disability due to low back pain) and 24 (maximum possible disability)
Measured: 1 week
digital algometer (Wagner, FPIX model)
Pain threshold assessment by pressing the sensitive points of the muscle
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start4 Dec 2018
- Primary completion4 Jan 2019
- Study completion4 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Caña Pino, University of Extremadura
- Investigators
- Jose Antonio JA Rodriguez-Pastor, PhD, Principal investigator, Universidad de Extremadura. Facultad de Medicina (Badajoz). SpainMª Dolores MD Apolo-Arenas, PhD, Study director, Universidad de Extremadura. Facultad de Medicina (Badajoz). SpainBerta BC Caro-Puértolas, PhD, Study director, Universidad de Extremadura. Facultad de Medicina (Badajoz). SpainAlejandro AC Caña-Pino, PT,MSc, Principal investigator, Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794830
- Sponsor's protocol ID
- 041218
- Status last verified
- Feb 2019
- First submitted
- 3 Jan 2019
- Last updated
- 8 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Manipulation of the Sacroiliac Joint on Low Back Pain With or Without Radiation to Lower Limbs
- ClinicalTrials.gov ID
- NCT03794830
- Acronym / sponsor ID
- 041218
- Conditions
- Low Back Pain, Sacroiliac Disorder
- Keywords
- sacroiliac joint, low back pain, Osteopathic manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 4 Jan 2019 (actual)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary focus of this study is to know the influence of sacroiliac joint manipulation on low back pain with or without radiation to lower limbs, in the lumbopelvic-hip joint
Detailed description
One of the main problems faced by physiotherapists in primary care is low back pain with or without radiation to lower limbs. Nowadays, there are a lot of types of low back pain interventions, yet despite the vast amount of research findings, the evidence remains contradictory and inconclusive: Pharmacological treatments like NSAIDs have shown result in acute low back pain but not in chronic pain; conservative interventions (ultrasound, interferential currents, mechanical traction and massage) have been studied and found ineffective.
A total of 151 low back pain patients with or without radiation to lower limbs between 18-70 years old derived from the Physiotherapy Unit of Gévora Health Center (Badajoz, Spain) voluntarily entered the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manipulation group (MG) | Experimental | Other: manipulation group (MG)Patients were treated with sacroiliac joint osteopathic semidirect manipulation twice a week every 3 to 4 days over a period of time of 3 weeks |
| electrotherapy group (EG) | Active comparator | Other: electrotheraphy group (EG)Patients were treated with micro-waves (circular antenna in lumbar area, pulsating-mode 120W for 12 minutes) and later conventional analgesic TENS (80Hz frequency, 30 minutes) 5 days per week over a period of time of 3 weeks (15 sessions of electrotherapy). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- dysfunction or sacroiliac joint hypomobility (SI)
- having stopped taking anti-inflammatory medicines or analgesics three days before the study began
Key exclusion criteria (12 listed)
- destructive injuries of the spine and pelvis
- fractures
- lumbar surgery
- sacroiliac instability
- spondylolisthesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manipulation group (MG)Patients were treated with sacroiliac joint osteopathic semidirect manipulation twice a week every 3 to 4 days over a period of time of 3 weeks | Other | manipulation group (MG) |
| electrotheraphy group (EG)Patients were treated with micro-waves (circular antenna in lumbar area, pulsating-mode 120W for 12 minutes) and later conventional analgesic TENS (80Hz frequency, 30 minutes) 5 days per week over a period of time of 3 weeks (15 sessions) | Other | electrotherapy group (EG) |
Primary outcome
visual analogue scale (VAS)
Time frame: 1 week
Pain assessment from 0 to 10. 0: no pain 10: maximum pain
Oswestry disability index (ODI)
Time frame: 1 week
disability assessment 0% -20% (Minimum Disability) 21% -40% (Moderate disability) 41% -60% (Severe disability) 61% -100% (Disabled):
Roland Morris questionnaire
Time frame: 1 week
disability assessment The extreme values oscillate between 0 (absence of disability due to low back pain) and 24 (maximum possible disability)
digital algometer (Wagner, FPIX model)
Time frame: 1 week
Pain threshold assessment by pressing the sensitive points of the muscle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Antonio JA Rodriguez-Pastor, PhD principal investigator
Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
Mª Dolores MD Apolo-Arenas, PhD study director
Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
Berta BC Caro-Puértolas, PhD study director
Universidad de Extremadura. Facultad de Medicina (Badajoz). Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manipulation group (MG) and electrotheraphy group (EG) in people with Low Back Pain and Sacroiliac Disorder, run by University of Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (VAS) (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.