Back PainNCT00757016
Injection Treatment of Corticosteroid to Pelvic Ligament Insertions on Women With Longlasting Backpain After Pregnancy
A study testing Triamcinolone and Saline solution in people with Back Pain, run by Sundsvall Hospital at 1 site in Sweden.
Trial summary
To evaluate the pain relief effect of locally injected corticosteroid treatment in women with long-lasting low back pain beginning in pregnancy. We hypothesize that the insertion of the sacrospinous ligament on the ischial spine would be a source of pain and therefore be a target for therapy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Back Pain
- What is being tested?
- Triamcinolone and Saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2004to Nov 2007
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- reported ongoing pain in the sacral region with onset during pregnancy with six months to seven years duration after delivery
- reported pain intensity at present between 30 and 50 mm on a 100 mm horizontal visual analogue scale (VAS)
- at least one positive pain provocation test out of three and pain elicited on internal palpation at the ischial spine at least unilaterally.
Who cannot join
- on-going low back pain with onset before pregnancy
- previous back surgery
- positive straight leg-raising test
- loss of tendinous reflex in the legs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Injection Treatment of Slow-Release Corticosteroid to the Sacrospinous Ligament Insertions on Women With Long-Lasting Low Back Pain Starting in Pregnancy.
To evaluate the pain relief effect of locally injected corticosteroid treatment in women with long-lasting low back pain beginning in pregnancy. We hypothesize that the insertion of the sacrospinous ligament on the ischial spine would be a source of pain and therefore be a target for therapy.
Primary outcome measure is reported pain intensity on visual analogue scale and secondary outcome measures number of pain-drawing locations, pain-provoking test results and tests of function.
Read the detailed description
Pregnancy related low back pain is a global problem. In most women low back pain induced in pregnancy disappears during the first six months after delivery. However, one of five women with pain during pregnancy from both sacroiliac regions and the symphysis still experienced disabling daily back pain two years after childbirth, which corresponded to 8% of the total study population. Hence, long-lasting low back pain with onset during pregnancy has to be considered a major public health problem, with high impact on the individual, family and society. Despite this, treatment and care is directed to general pain relief methods.
Precise localization of the site of pain release is fundamental in the search for an effective treatment. To date, the source of such pregnancy related low back pain is uncertain. However, the pelvic ligaments or their insertions have been proposed a source of pain and in particular the sacrospinous/sacrotuberous ligament has been indicated in this respect in pregnant and non-pregnant women.
Injection treatment with slow-release corticosteroid has shown a positive effect on pain conditions where the pain is thought to derive from collagen tissues.
We hypothesize that the insertion of the sacrospinous ligament on the ischial spine could be a source of pain in women with long-lasting low back pain beginning in pregnancy and might therefore be a target for therapy.
The women included will be randomized according to a computer generated random allocation sequence, with block size of four, concealed from the investigators until study closure.
A physiotherapist will perform the assessments at baseline and follow up four weeks after treatment. The assessment will consist of a questionnaire and a clinical examination of the back and pelvis.
Participants will be randomized to receive an injection treatment of either a compound of 1 ml triamcinolone 20mg/ml (Lederspan), Meda AB, Solna, Sweden) and 1 ml lidocaine hydrochloride 10mg/ml (Xylocain), Astra Zeneca, Södertälje, Sweden) or 0.99 ml saline solution 9mg/ml, 1 ml lidocaine hydrochloride and 0.01 ml fat emulsion (Intralipid), Fresenius Kabi, Uppsala, Sweden), the latter to make the solution opalescent as Lederspan.
Not the participant, the physician who will give the injection or the assessing physiotherapist will have information about what treatment that will be given.
- Conditions
- Back Pain
- Being tested
- Triamcinolone, Saline solution
- Keywords
- low back pain, randomised controlled trial, slow release corticosteroid, injection treatment
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriamcinoloneDrug
Also called Lederspan, Meda AB, Solna, Sweden (Triamcinolone)
1 ml triamcinolone 20mg/ml will be given once to the insertion of the sacrospinous ligament bilaterally.
Saline solutionDrug
Saline solution
| Study group | Role | What they receive |
|---|---|---|
| B | Placebo comparator | 0.99 ml saline solution 9mg/ml and 0.01 ml fat emulsion will be given once to the sacrospinous ligament insertion. Receives: Drug: Saline solution |
| A | Active comparator | 1 ml triamcinolone 20mg/ml (Lederspan), Meda AB, Solna, Sweden) and 1 ml lidocaine hydrochloride 10mg/ml (Xylocain), Astra Zeneca, Södertälje, Sweden) Receives: Drug: Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported pain intensity on visual analogue scale
Secondary outcomes (1)
Physical function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startOct 2004
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sundsvall Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Per OJ Kristiansson, M.D., Ph.D., Principal investigator, County Council of Västernorrland, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757016
- Sponsor's protocol ID
- SundsvallH
- Status last verified
- Sep 2008
- First submitted
- 19 Sep 2008
- Last updated
- 22 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Torstensson T, Lindgren A, Kristiansson P. Improved function in women with persistent pregnancy-related pelvic pain after a single corticosteroid injection to the ischiadic spine: a randomized double-blind controlled trial. Physiother Theory Pract. 2013 Jul;29(5):371-8. doi: 10.3109/09593985.2012.734009.
PubMed 23713407
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection Treatment of Slow-Release Corticosteroid to the Sacrospinous Ligament Insertions on Women With Long-Lasting Low Back Pain Starting in Pregnancy.
- ClinicalTrials.gov ID
- NCT00757016
- Acronym / sponsor ID
- SundsvallH
- Conditions
- Back Pain
- Keywords
- low back pain, randomised controlled trial, slow release corticosteroid, injection treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Sundsvall HospitalUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 22 Sep 2008 (estimated)
- 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.
To evaluate the pain relief effect of locally injected corticosteroid treatment in women with long-lasting low back pain beginning in pregnancy. We hypothesize that the insertion of the sacrospinous ligament on the ischial spine would be a source of pain and therefore be a target for therapy.
Primary outcome measure is reported pain intensity on visual analogue scale and secondary outcome measures number of pain-drawing locations, pain-provoking test results and tests of function.
Detailed description
Pregnancy related low back pain is a global problem. In most women low back pain induced in pregnancy disappears during the first six months after delivery. However, one of five women with pain during pregnancy from both sacroiliac regions and the symphysis still experienced disabling daily back pain two years after childbirth, which corresponded to 8% of the total study population. Hence, long-lasting low back pain with onset during pregnancy has to be considered a major public health problem, with high impact on the individual, family and society. Despite this, treatment and care is directed to general pain relief methods.
Precise localization of the site of pain release is fundamental in the search for an effective treatment. To date, the source of such pregnancy related low back pain is uncertain. However, the pelvic ligaments or their insertions have been proposed a source of pain and in particular the sacrospinous/sacrotuberous ligament has been indicated in this respect in pregnant and non-pregnant women.
Injection treatment with slow-release corticosteroid has shown a positive effect on pain conditions where the pain is thought to derive from collagen tissues.
We hypothesize that the insertion of the sacrospinous ligament on the ischial spine could be a source of pain in women with long-lasting low back pain beginning in pregnancy and might therefore be a target for therapy.
The women included will be randomized according to a computer generated random allocation sequence, with block size of four, concealed from the investigators until study closure.
A physiotherapist will perform the assessments at baseline and follow up four weeks after treatment. The assessment will consist of a questionnaire and a clinical examination of the back and pelvis.
Participants will be randomized to receive an injection treatment of either a compound of 1 ml triamcinolone 20mg/ml (Lederspan), Meda AB, Solna, Sweden) and 1 ml lidocaine hydrochloride 10mg/ml (Xylocain), Astra Zeneca, Södertälje, Sweden) or 0.99 ml saline solution 9mg/ml, 1 ml lidocaine hydrochloride and 0.01 ml fat emulsion (Intralipid), Fresenius Kabi, Uppsala, Sweden), the latter to make the solution opalescent as Lederspan.
Not the participant, the physician who will give the injection or the assessing physiotherapist will have information about what treatment that will be given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Placebo comparator | Drug: Saline solution0.99 ml saline solution 9mg/ml and 0.01 ml fat emulsion will be given once to the sacrospinous ligament insertion. |
| A | Active comparator | Drug: Triamcinolone1 ml triamcinolone 20mg/ml (Lederspan), Meda AB, Solna, Sweden) and 1 ml lidocaine hydrochloride 10mg/ml (Xylocain), Astra Zeneca, Södertälje, Sweden) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- reported ongoing pain in the sacral region with onset during pregnancy with six months to seven years duration after delivery
- reported pain intensity at present between 30 and 50 mm on a 100 mm horizontal visual analogue scale (VAS)
- at least one positive pain provocation test out of three and pain elicited on internal palpation at the ischial spine at least unilaterally.
Key exclusion criteria (4 listed)
- on-going low back pain with onset before pregnancy
- previous back surgery
- positive straight leg-raising test
- loss of tendinous reflex in the legs
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 |
|---|---|---|
| TriamcinoloneAlso: Lederspan, Meda AB, Solna, Sweden (Triamcinolone)1 ml triamcinolone 20mg/ml will be given once to the insertion of the sacrospinous ligament bilaterally. | Drug | A |
| Saline solutionSaline solution | Drug | B |
Primary outcome
Reported pain intensity on visual analogue scale
1 secondary outcome
Physical function
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 22 Sep 2008.
- Derived from this study: PubMed 23713407Torstensson T, Lindgren A, Kristiansson P. Improved function in women with persistent pregnancy-related pelvic pain after a single corticosteroid injection to the ischiadic spine: a randomized double-blind controlled trial. Physiother Theory Pract. 2013 Jul;29(5):371-8. doi: 10.3109/09593985.2012.734009.
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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.
Per OJ Kristiansson, M.D., Ph.D. principal investigator
County Council of Västernorrland, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone and Saline solution in people with Back Pain, run by Sundsvall Hospital at 1 site in Sweden.
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 3 inclusion and 4 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 22 Sep 2008. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
Reported pain intensity on visual analogue scale. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00757016, which also lists 1 linked publication.
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 22 Sep 2008.