Spinal Stensis-Clinical Trials- Part II of a II Part Article on Stenosis

(7/5/14)- The results of a study involving 400 patients at 16 sites throughout the U.S. found that the subjects who received a spinal steroidal cortisone shot along with a local anesthetic (lidocaine) had no less pain and virtually no greater function after 6 weeks than those who received only the local injection.

The FDA had warned in April that steroidal injections are safe but that in addition to a slight increased  risk of infection, headaches and sleeplessness, that in rare cases in may cause blindness, stroke, paralysis or even death. The effectiveness of the shot “has not been established.”

Research has shown that a third of the population over 60 have some narrowing of the spine, which in turn narrows the space between the vertebrae in the spine putting pressure on nerves and causing pain or numbness in the back and the legs.

Steroidal injections reduce the inflammation, and are ofter tried when physical therapy and anti-inflammatory medications do not work. These injections are considered effective for other conditions like herniated discs. About 2.2 million of these shots were given to people on Medicare last year.

Dr. Janna  Friedly, a professor of rehabilitation medicine at the University of Washington was the lead author of the study. She said the injections cost about $500 to $2,000 each The study hel;ps answer questions raised by the Spine Society and the Cochrane Collaboration, a group of medical experts, that found that the shot has not be proven to be effective in treating stenosis.

The research was funded by the federal Agency for Healthcare Research and Quality.

The study did not involve patients with central stenosis, not stenosis on one side, which was my problem that I had written about in my article on my “Personal Battle with Stenosis”.

(12/6/12)- Postmenopausal women suffered significant bone density loss in their hip after they were treated with an epidural steroid injection for back pain relief, according to a new study. Bone density loss after six months was six times greater when compared to the typical bone density loss seen in a year in a postmenopausal woman who doesn't receive steroid injection, researchers say. The study will be published in the Dec.1 edition of Spine.

(2/12/09)- The North American Spine Society (NASS), a medical society representing over 5,000 spine surgeons has adopted a new disclosure policy that will apply to doctors who present studies at future medical conferences. The policy requires that researchers disclose not just the existence of financial ties to medical-device companies, but the dollar amounts as well.

The society said its policy "is not a voluntary guideline, but a binding covenant which applies to all relationships engaged in by all participants in all" activities of the spine society. Violations of this policy could include suspension, expulsion or public censure to a member of the society. The sanction would not restrict a violator from continuing to practice medicine, but would be a blot on the record of a member who was censured.

(10/21/06)- Sadly, stenosis is a not uncommon issue in the elderly. The figures indicate that 5 out of every 1000 person over 50 has stenosis. We are listing some of the different clinical trials that have already taken place or will be taking place involving studies of spinal stenosis in the hope that this information may be of some use to our viewers.

Department of Orthopaedics, University Hospitals of Leicester, Leicestershire, UK,
a.. Tafazal SI,
b.. Ng L,
c.. Sell P.

This is a double blind randomized controlled trial to assess the effectiveness of nasal salmon calcitonin in the treatment of lumbar spinal stenosis. The trial compared the outcome of salmon calcitonin nasal spray to placebo nasal spray in patients with MRI confirmed lumbar spinal stenosis. Lumbar spinal stenosis is one of the commonest conditions encountered by spine surgeons. It more frequently affects elderly patients and lumbar decompression has been used to treat the condition with variable success. Non operative measures have been investigated, but their success ranges from 15% to 43% in patients followed up for 1-5 years (Simotas in Clin Orthop 1(384):153-161, 2001). Salmon calcitonin injections have been investigated in previous trials and may have a treatment effect. Nasal salmon calcitonin has become available and if effective would have advantages over injections. Forty patients with symptoms of neurogenic claudication and MRI proven lumbar spinal stenosis were randomly assigned either nasal salmon calcitonin or placebo nasal spray to use for 4 weeks. This was followed by a 'washout' period of 6 weeks, and subsequent treatment with 6 weeks of nasal salmon calcitonin. Standard spine outcome measures including Oswestry disability index (ODI), low back outcome score, visual analogue score and shuttle walking test were administered at baseline, 4, 10 and 16 weeks. Twenty patients received nasal salmon calcitonin and twenty patients received placebo nasal spray. At 4 weeks post treatment there was no statistically significant difference in the outcome measures between the two groups. The change in ODI was a mean 1.3 points for the calcitonin group and 0.6 points for the placebo group (P = 0.51), the mean change in visual analogue score for leg pain was 10 mm in the calcitonin group and 0 mm in the placebo group (P = 0.51). There was no significant difference in walking distance between the two groups, with a mean improvement in walking distance of 21 m in the calcitonin group and 8 m in the placebo group (P = 0.78). At the end of the trial the ODI had improved by a mean of 3.7 points in the calcitonin group and 3.8 points in the placebo group (P = 0.44). This randomised placebo controlled trial has not shown any treatment effect in patients with lumbar spinal stenosis treated with nasal salmon calcitonin.

Effects of lumbar acupuncture stimulation on blood flow to the sciatic nerve trunk--an exploratory study.
a.. Inoue M,
b.. Hojo T,
c.. Yano T,
d.. Katsumi Y.
Meiji University of Oriental Medicine, Kyoto, Japan.
Acupunct Med. 2005 Dec;23(4):166-70. Links

INTRODUCTION: Acupuncture may have a role in the treatment of intermittent claudication of the cauda equina due to lumbar spinal canal stenosis. The aim of this study was to explore the possible physiological mechanisms. METHODS: In a laboratory experiment, manual acupuncture was performed at a point adjacent to the sixth lumbar vertebra of 13 animals and its effect on sciatic nerve blood flow was measured using a laser Doppler flowmetry. Simultaneously, changes in blood pressure and cardiac rate were observed. Each animal was stimulated four to eight times, making a total of 58 experiments. RESULTS: Acupuncture stimulation did not produce consistent changes in sciatic nerve blood flow, with increased and decreased blood flow as well as no change in blood flow observed. Among the 58 individual experiments, sciatic nerve blood flow was increased in 33, reduced in 12, and unchanged in 13. Approximately half of the stimulations showed a correlation between blood flow and blood pressure change. CONCLUSION: Our results indicate that lumbar acupuncture stimulation can have an influence on sciatic nerve blood flow. The effect is dependent not only on blood pressure but also other factors, for example vasodilator and vasoconstrictor nerve activity. This mechanism may contribute to a clinical effect on intermittent claudication of the cauda equina.

Please see our other article on Spinal Stenosis- A Personal Chronicle - Part I
Spinal Stenosis- What has Worked or not Worked for our Viewers- Part III


Compiled by Harold Rubin
updated July 5, 2014

e-mail: or

Return to Home